Prescribing medicines in pregnancy, 4th edition
Australian categorisation of drugs
This document is part of Prescribing medicines in pregnancy, 4th edition <http://www.tga.gov.au/docs/html/medpreg.htm>.
Australian categorisation of drugs
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Alimentary system
Hyperacidity, reflux, ulcers
Alginates/antacids Category A
Bismuth subcitrate Category B2
Cimetidine, cisapride, famotidine, ranitidine, sucralfate Category B1
Lansoprazole, nizatidine, omeprazole, pantoprazole Category B3
Misoprostol Category X
This drug can produce serious birth defects. It also can cause miscarriage that could lead to potentially dangerous bleeding.
Antispasmodics
Atropine Category A
Glycopyrrolate, hyoscine-N-butylbromide, mebeverine, propantheline Category B2
Laxatives
Bisacodyl, cascara, docusate sodium, senna Category A
Dicyclomine hydrochloride Category B1
Phenolphthalein Category B2
Antidiarrhoeals
Diphenoxylate Category C
This drug is chemically related to the narcotic analgesic pethidine. Narcotic analgesics may cause respiratory depression in the newborn infant. This drug should not be given at or near term.
Hyoscyamine Category B2
Loperamide Category B3
Mesalazine, olsalazine Category C
Non-steroidal anti-inflammatory drugs inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with non-steroidal anti-inflammatory drugs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided.
Sulfasalazine Category A
Systemic budesonide Category B3
Cholelitholytics
Chenodeoxycholic acid Category B3
Cardiovascular system
Antihypertensives
Clonidine, doxazosin Category B3
Diazoxide Category C
This drug may cause fetal bradycardia. Hyperglycaemia has been observed in the newborn. Diazoxide is a potent relaxant of uterine smooth muscle and may inhibit uterine contraction if given during labour. Diazoxide should be used with extreme caution during pregnancy.
Guanethidine, methyldopa Category A
Hydralazine Category C
Following intravenous administration, hydralazine has been associated with fetal distress and fetal arrhythmia in the last trimester of pregnancy.
Minoxidil Category C
This drug has been associated with hypertrichosis in the newborn infant following exposure in utero.
Prazosin, terazosin Category B2
Sodium nitroprusside Category C
Short term use for the control of hypertensive crises may be safe provided that the pH and cyanide concentrations in maternal blood are monitored.
Angiotensin converting enzyme (ACE) inhibitors
When taken during the second and third trimesters, ACE inhibitors cause a range of abnormalities including renal dysfunction and oligohydramnios. These can be associated with fetal death in utero.
Although no adverse fetal effects have been linked to first trimester drug use of ACE inhibitors, the number of exposures reported is too small to determine conclusively that ACE inhibitors are safe in the first trimester. Pregnant women who are taking ACE inhibitors should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure.
It is generally advisable not to use ACE inhibitors for the management of hypertension in women who are likely to become pregnant.
Captopril, cilazapril, enalapril, fosinopril, lisinopril, perindopril, quinapril, ramipril, trandolapril Category D
Angiotensin II receptor antagonists (ARAs)
When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus.
Although no adverse fetal effects have been linked to first trimester drug use of ARAs, the number of exposures reported is too small to determine conclusively that ARAs are safe in the first trimester. Pregnant women who are taking ARAs should be changed as quickly as possible to other antihypertensive medication to maintain normal blood pressure. It is generally advisable not to use ARAs for the management of hypertension in women who are likely to become pregnant.
Candesartan cilexetil, eprosartan, irbesartan, losartan, valsartan Category D
Calcium channel blockers
These drugs carry the potential to produce fetal hypoxia associated with maternal hypotension.
Amlodipine, diltiazem, felodipine, isradipine, nicardipine, nifedipine, nimodipine, nisoldipine, verapamil Category C
Beta-adrenergic blocking agents
These agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant.
Alprenolol, atenolol, betaxolol, bevantolol, carvedilol, esmolol, labetalol, levobunolol, metoprolol, oxprenolol, pindolol, propranolol, sotalol, timolol Category C
Diuretics
Carbonic anhydrase inhibitor
Acetazolamide Category B3
Thiazides, related diuretics and loop diuretics
These drugs may cause electrolyte disturbances in the fetus. Neonatal thrombocytopenia has been reported with thiazides and related diuretics. Loop diuretics, like frusemide and bumetanide, are probably also associated with this risk. During the latter part of pregnancy products of this type should only be given on sound indications, and then in the lowest effective dose.
Bendrofluazide, bumetanide, chlorothiazide, chlorthalidone, clopamide, cyclopenthiazide, ethacrynic acid, frusemide, hydrochlorothiazide, indapamide, mefruside, methychlothiazide, metolazone, quinethazone Category C
Potassium sparing diuretics
Amiloride, triamterene Category C
These drugs may result in electrolyte disturbances in the fetus.
Spironolactone Category B3
This drug carries the potential to cause feminisation of the male fetus and should be avoided during pregnancy.
Antiarrhythmics
Adenosine, disopyramide, procainamideCategory B2
Amiodarone Category C
Because of the long half-life of amiodarone and its major metabolite, and the potential to cause abnormal thyroid function and bradycardia in the fetus, its use is probably best avoided in the three months before and throughout the duration of pregnancy. When exposure of the fetus is unavoidable, thyroid function (including TSH) should be assessed promptly in the newborn infant.
Bretylium tosylate Category C
This drug carries the potential for fetal hypoxia associated with maternal hypotension.
Flecainide Category B3
Lignocaine Category A
Mexiletine Category B1
Quinidine Category C
This drug is structurally similar to quinine, which in high doses, has been shown to cause fetal damage. It has been used to treat fetal cardiac arrhythmia.
Antiangina agents
Glyceryl trinitrate, isosorbide mononitrate, perhexilene Category B2
Isosorbide dinitrate, tirofiban hydrochloride Category B1
Nicorandil Category B3
Hypolipidaemic agents
The physiological hyperlipidaemia of pregnancy does not require treatment.
Atorvastatin, cerivastatin, fluvastatin, pravastatin, simvastatin Category D
Cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, these drugs may cause fetal harm when administered to a pregnant woman.
Cholestyramine, colestipol, nicotinic acid Category B2
Clofibrate, probucol Category B1
Gemfibrozil Category B3
Cardiac inotropic agents
Digoxin and other cardiac glycosides Category A
Milrinone Category B3
Adrenergic stimulants
Adrenaline, ephedrine, fenoterol, isoprenaline, orciprenaline, rimiterol, salbutamol, terbutaline Category A
Dobutamine, phenylephrine, phenylpropanolamine, pseudoephedrine Category B2
Dopamine Category B3
Metaraminol Category C
This drug may cause fetal hypoxia by constricting the uterine vessels thereby limiting placental perfusion.
Vasodilators
Betahistine, glyceryl trinitrate, nicotinic acid Category B2
Dipyridamole, isosorbide dinitrate, nicotinyl alcohol, oxpentifylline, phentolamine, sildenafil citrate Category B1
Isoxsuprine Category C
Maternal isoxsuprine administration for prevention of premature labour has been associated with tachycardia, hypoglycaemia, hypocalcaemia, ileus and hypotension in the neonate.
Papaverine Category A
Phenoxybenzamine Category B2
This drug is known to be mutagenic and carcinogenic in rodents.
Antimigraine preparations
Dihydroergotamine, ergotamine, methysergide Category C
Standard oral dose regimens for migraine headaches in the first half of pregnancy do not appear to pose hazards to the fetus. Ergotamine induces uterine contraction and may therefore cause premature parturition or hypertonic labour. Larger doses or more frequent use may jeopardise the fetus because of the potential for impeding fetal blood supply.
Naratriptan, sumatriptan, zolmitriptan Category B3
Pizotifen Category B1
Anticoagulants and thrombolytic agents
All of these agents can produce placental haemorrhage and subsequent prematurity and fetal loss.
Abciximab Category C
Dalteparin, danaparoid, enoxaparin, nadroparin, Category C
Desirudin Category B3
Heparin Category C
Phenindione Category D
This drug can cause birth defects when used in the first trimester of pregnancy.
Ticlopidine Category B1
Warfarin Category D
Warfarin has been associated with the development of a specific embryopathy following exposure at 6 to 9 weeks post conception. Exposure following first trimester of pregnancy can cause fetal bleeding leading to CNS damage. There is also an increased risk of spontaneous abortion and perinatal bleeding. It should not be used in the last few weeks of pregnancy.
Haemostatic agents
Aprotinin, eptacog alfa, tranexamic acid Category B1
Human coagulation factor IX Category C
The safe use of this drug during pregnancy has not been established in controlled clinical trials.
Kogenate, protamine Category B2
Aminocaproic acid, ornipressin Category B3
Fibrinolytic agents
Alteplase, urokinase Category B1
Reteplase Category C
Streptokinase Category C
Only minimal amounts of streptokinase cross the placenta. Streptokinase-specific antibodies are found in fetal blood.
Other cardiovascular agents
Oxpentifylline Category B1
Tirilazad Category B2
Drugs affecting blood and haemopoietic tissues
Iron and haemopoietic agents
Erythropoietin, filgrastim, lenograstim, molgramostim Category B3
Folic acid Category A
Folinic acid Category A
Oral iron preparations (with or without folic acid), parenteral iron preparations Category A
Central nervous system
Analgesics, antipyretics
(See also non-steroidal anti-inflammatory drugs)
Opioid analgesics
Opioid analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs.
Alfentanil, buprenorphine, dextromoramide, dextropropoxyphene, fentanyl, hydromorphone, methadone, morphine, oxycodone, papaveretum, pentazocine, pethidine, phenoperidine, remifentanil, tramadol Category C
Aspirin Category C
Aspirin inhibits prostaglandin synthesis. When given late in pregnancy, it may cause premature closure of the fetal ductus arteriosus, delay labour and birth. Aspirin increases the bleeding time both in the newborn infant and in the mother because of its antiplatelet effects. Products containing aspirin should be avoided in the last trimester. Low-dose aspirin (100mg/day) does not affect bleeding time.
Codeine, dihydrocodeine Category A
Prolonged high-dose use of codeine prior to delivery may produce codeine withdrawal symptoms in the neonate.
Paracetamol Category A
Hypnotics and sedatives
Barbiturates
These drugs can give rise to hypotension, respiratory depression and hypothermia in the newborn infant. Continuous treatment during pregnancy and administration during labour should be avoided.
Amylobarbitone, pentobarbitone Category C
Other hypnotics and sedatives
Chloral hydrate, chlormethiazole Category A
Meprobamate Category C
This drug may cause hypotension, respiratory depression and hypothermia in the newborn infant.
Zolpidem tartrate Category B3
Zopiclone Category C
This drug is likely to produce CNS depression in newborn infants when given during labour.
Antianxiety agents
Buspirone Category B1
Benzodiazepines
Benzodiazepines may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with prolonged use of this class of drugs.
Alprazolam, bromazepam, chlordiazepoxide, clobazam, clonazepam, clorazepate, diazepam, flunitrazepam, flurazepam, lorazepam, midazolam, nitrazepam, oxazepam, temazepam, triazolam Category C
Antipsychotic agents
Phenothiazines
When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the newborn infant.
Chlorpromazine, fluphenazine, pericyazine, perphenazine, promazine, thiopropazate, thioridazine, trifluoperazine Category C
Butyrophenones
When given in high doses during late pregnancy, butyrophenones may cause prolonged neurological disturbances in the newborn infant.
Droperidol, haloperidol Category C
Other antipsychotic drugs
Clozapine Category C
The adverse pharmacological and toxicological effects of clozapine in adults may also occur in the fetus.
Flupenthixol Category C
When given in high doses during late pregnancy, related compounds have caused prolonged neurological disturbances in the newborn infant.
Lithium salts Category D
The risk of birth defects may be increased when lithium is used during the first trimester. Second trimester detailed ultrasound examination and fetal echocardiography should be considered for women who have been treated with lithium during the first trimester of pregnancy. The newborn may show signs of lithium toxicity.
Olanzapine, risperidone Category B3
Pimozide, thiothixene Category B1
Zuclopenthixol Category C
When given in high doses during late pregnancy, related compounds have caused prolonged neurological disturbances in the newborn infant.
Antidepressants
Selective serotonin reuptake inhibitors (SSRIs)
SSRIs have had limited use in pregnancy without a reported increase in birth defects. The use of SSRIs in the third trimester may result in a withdrawal state in the newborn infant.
Citalopram, fluoxetine, fluvoxamine, paroxetine*, sertraline Category C
*In September 2005, the categorisation of paroxetine was changed from Category C to Category D. Further information can be located at:
Tricyclic antidepressants
Withdrawal symptoms in newborn infants have been reported with prolonged maternal use of this class of drugs.
Amitriptyline, clomipramine, desipramine, dothiepin, doxepin, imipramine, nortriptyline, protriptyline, trimipramine Category C
Tetracyclic antidepressants
Mianserin Category B2
Monoamine oxidase inhibitors
Phenelzine Category B3
Tranylcypromine Category B2
Other antidepressants
Mirtazapine, moclobemide, nefazodone Category B3
Venlafaxine Category B2
CNS stimulants
Caffeine Category A
Dextroamphetamine Category B3
Methylphenidate Category B2
Antiparkinson agents
Amantadine, apomorphine, benserazide, carbidopa, entacapone, levodopa, ropinirole Category B3
Benztropine, biperiden, selegiline Category B2
Benzhexol Category B1
Pergolide Category C
Studies in rodents have shown no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.
Procyclidine Category A
Anticonvulsants / Antiepileptics
The risk of having an abnormal child as a result of antiepileptic medication is far outweighed by the dangers to the mother and fetus of uncontrolled epilepsy.
It is recommended that:
- women on antiepileptic drugs (AEDs) receive prepregnancy counselling with regard to the risk of fetal abnormalities;
- AEDs should be continued during pregnancy and monotherapy should be used if possible at the lowest effective dose as risk of abnormality is greater in women taking combined medication;
- folic acid supplementation (5mg) should be commenced four weeks prior to and continue for twelve weeks after conception;
- Specialist prenatal diagnosis including detailed mid-trimester ultrasound should be offered.
Commonly Prescribed Anticonvulsants/Antiepileptics
Carbamazepine Category D
Spina bifida occurs in about one percent of pregnancies in which carbamazepine is used as monotherapy. Carbamazepine taken during pregnancy also has been associated with minor craniofacial defects, fingernail hypoplasia and developmental disability. Carbamazepine also can cause coagulation defects with consequent risk of haemorrhage in the fetus and the newborn infant which may be preventable by the prophylactic administration of vitamin K to the mother prior to delivery.
Phenytoin sodium Category D
This drug taken during pregnancy has been associated with craniofacial defects, fingernail hypoplasia, developmental disability, growth retardation and less frequently, oral clefts and cardiac anomalies. This clinical pattern is sometimes called the 'fetal hydantoin syndrome'. Phenytoin also can cause coagulation defects with consequent risk of haemorrhage in the fetus and the newborn infant which may be preventable by the prophylactic administration of vitamin K to the mother prior to delivery.
Methylphenobarbitone, phenobarbitone, primidone Category D
The use in pregnancy of primidone, phenobarbitone or methylphenobarbitone has been associated with minor craniofacial defects, fingernail hypoplasia and developmental disability. Their use in pregnancy alone, or in combination with other anticonvulsants, can cause coagulation defects in the newborn infant which may be preventable by the prophylactic administration of vitamin K to the mother prior to delivery.
Sodium valproate (valproic acid) Category D
If taken in the first trimester of pregnancy, sodium valproate (valproic acid) is associated with a one to two percent risk of neural tube defects (especially spina bifida) in the exposed fetus. Women taking sodium valproate (valproic acid) who become pregnant should be encouraged to consider detailed mid-trimester morphology ultrasound for prenatal diagnosis of such abnormalities.
Other anticonvulsants / antiepileptics
Compared to conventional anticonvulsants, the extent of the risk of the following drugs is unknown.
Clonazepam Category C
Clonazepam is a benzodiazepine. These drugs may cause hypotonia, respiratory depression and hypothermia in the newborn infant if used in high doses during labour. Withdrawal symptoms in newborn infants have been reported with this class of drugs.
Lamotrigine, ethosuximide, methsuximide, phensuximide, sulthiame, vigabatrin Category D
Gabapentin Category B1
Tiagabine, topiramate Category B3
Antiemetics, antinauseants
Phenothiazines
When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the infant.
Prochlorperazine, promethazine, thiethylperazine Category C
Others
Dimenhydrinate, diphenhydramine, metoclopramide Category A
Dolasetron, granisetron, ondansetron Category B1
Domperidone, hyoscine, hyoscine hydrobromide Category B2
Tropisetron Category B3
Other agents acting on the CNS
Tetrabenazine Category B2
Musculoskeletal system
Non-steroidal anti-inflammatory drugs (NSAIDs)
(See also analgesics, antipyretics)
These agents inhibit prostaglandin synthesis and, when given during the latter part of pregnancy, may cause closure of the fetal ductus arteriosus, fetal renal impairment, inhibition of platelet aggregation, and delay labour and birth. Continuous treatment with NSAIDs during the last trimester of pregnancy should only be given on sound indications. During the last few days before expected birth, agents with an inhibitory effect on prostaglandin synthesis should be avoided.
Diclofenac, diflunisal, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, nabumetone, naproxen, phenylbutazone, piroxicam, sodium salicylate, sulindac, tenoxicam, tiaprofenic acid Category C
Antirheumatoid agents
Aurothioglucose, sodium aurothiomalate, Category B2
Auranofin Category B3
Hydroxychloroquine Category D
When used in high doses and for prolonged periods, chloroquine and related substances may cause neurological disturbances and interference with hearing, balance and vision in the fetus.
Penicillamine Category D
This drug can cause cutis laxa in the human fetus.
Muscle relaxants
Baclofen, botulinum type A Category B3
Dantrolene, methocarbamol, orphenadrine Category B2
Physostigime Category C
Quinine Category D
At standard doses, quinine has not been associated with fetal damage. In toxic doses, quinine causes fetal damage including deafness. Its ability to induce uterine contractions also constitutes a risk of abortion.
Agents used in gout and hyperuricaemia
Allopurinol, colchicine, probenecid, sulfinpyrazone Category B2
Endocrine system
Oestrogens (see oral contraceptives)
Dienoestrol Category X
Ethinyloestradiol, mestranol Category B3
Oestradiol, oestriol, oestrone, piperazine oestrone sulfate Category B1
Oestrogens conjugated Category D
Progestogens (see oral contraceptives)
If taken by the mother at or after 8 weeks post conception, these drugs can cause virilisation of the female fetus. This is a dose-dependent effect. Prior to 8 weeks post conception, they have no virilising effects.
Dydrogesterone, hydroxyprogesterone, megestrol, norethisterone Category D
Medroxyprogesterone (oral high dose, 30-50mg daily) (see also contraceptives and anti-neoplastic agents) Category D
Antiandrogens
Antiandrogens carry the potential for feminisation of the male fetus at or after 8 weeks post conception and should be avoided during pregnancy.
Cyproterone acetate, spironolactone Category B3
Androgens and anabolic steroids
Anabolic steroids and other substances with androgenic effects may have a virilising effect on the female fetus and should be avoided during pregnancy.
Fluoxymesterone, methenolone, nandrolone, oxandrolone, oxymetholone, testosterone Category D
Corticosteroids
Systemic
Betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone, methylprednisolone, prednisolone, prednisone, triamcinolone Category A
Topical
Betamethasone, fludrocortisone, flumethasone, fluocinolone, fluocortolone, halcinonide, triamcinolone Category A
Methylprednisolone aceponate Category C
Mometasone Category B3
Inhalation/Intranasal
The benefits of asthma control outweigh any potential for an adverse pregnancy outcome.
Beclomethasone, flunisolide, fluticasone, triamcinolone Category B3
Budesonide Category A
Pituitary hormones
Corticotrophin Category A
Nafarelin, goserelin Category D
There is a theoretical risk of abortion or fetal abnormality if GnRH agonists are used during pregnancy.
Somatropin, thyrotrophin Category B2
Antidiuretics
Desmopressin, lypressin, vasopressin Category B2
Hypoglycaemic agents (oral)
It is important to achieve strict normoglycaemia during pregnancy. This may best be achieved by conversion to insulin therapy.
Acarbose, miglitol Category B3
Chlorpropamide, glibenclamide, gliclazide, glimepiride, glipizide, metformin, tolazamide, tolbutamide Category C
The sulphonylureas may enter the fetal circulation and may cause neonatal hypoglycaemia.
Thyroid hormones
Liothyronine, thyroxine Category A
Antithyroid agents
These agents may cause congenital goitre by inhibiting thyroxine synthesis in the fetus.
Carbimazole, propylthiouracil Category C
Agents affecting calcium and bone metabolism
Alendronate, clodronate, pamidronate Category B3
Calcitonin, salcatonin, tiludronate disodium Category B2
Calcitriol, dihydrotachysterol Category B3
Raloxifene Category X
This drug causes abnormalities of the developing reproductive system when administered to pregnant rabbits and may have a similar effect in human pregnancy.
Other hormonal agents
Aminoglutethimide Category D
There have been reports of pseudohermaphrodism with use of this drug in pregnancy.
Octreotide Category C
This drug may produce fetal growth retardation, probably due to suppression of growth hormone.
Pituitary inhibitors
Bromocriptine (oral) Category A
Bromocriptine (injection) Category B2
Cabergoline Category B1
Danazol Category D
If taken by the mother at or after 8 weeks post conception, danazol may cause virilisation of the female fetus. Prior to 8 weeks post conception it has no virilising effects. Danazol may not inhibit ovulation in all women.
Gestrinone Category D
This drug may interfere with pregnancy and in animal tests caused masculinisation of female fetuses. Gestrinone may not inhibit ovulation in all women.
Quinagolide Category B3
Ovulation inducers
Gonadotrophins
Human chorionic gonadotrophin Category A
Human menopausal gonadotrophin, urofollitrophin Category B2
Genitourinary system
Recombinant follicle stimulating hormone (FSH) Category B3
Clomiphene Category B3
Urinary antiseptics
Hexamine Category A
Bladder function disorders
Bethanechol Category B2
Bethanechol has a potent excitatory effect on smooth muscle and should be avoided during pregnancy.
Finasteride Category X
Finasteride may cause abnormalities of the external genitalia of a male fetus.
Oxybutynin, pentosan polysulfate sodium Category B1
Terazosin Category B2
Agents acting on the uterus
Ergometrine Category C
This drug induces uterine contraction and may cause premature or hypertonic labour. Products containing ergometrine should be avoided during pregnancy.
Gemeprost Category B3
Oxytocin Category A
There have been instances of idiosyncratic sensitivity of the uterus resulting in fetal anoxia.
Prostaglandin E2/Dinoprostone Category C
There have been instances of idiosyncratic sensitivity of the uterus resulting in fetal anoxia.
Salbutamol Category A
Topical vaginal medication
Clindamycin, clotrimazole, econazole, miconazole, nystatin Category A
Dienosliterol Category B1
Isoconazole Category B2
Antimicrobials
Cephalosporins
Cefaclor, cefotaxime, cefotetan, cefoxitin, cefpodoxime, ceftazidime, ceftriaxone, cephamandole, cephazolin Category B1
Cefodizime, cefpirome Category B2
Cephalexin, cephalothin Category A
Penicillins
Amoxycillin, ampicillin, benzathine penicillin, benzylpenicillin, phenoxymethylpenicillin, procaine penicillin Category A
Amoxycillin with clavulanic acid, flucloxacillin, mezlocillin, piperacillin, piperacillin with tazobactam Category B1
Azlocillin Category B3
Dicloxacillin, ticarcillin sodium with potassium clavulanate Category B2
Tetracyclines
Tetracyclines are safe for use during the first 18 weeks of pregnancy (16 weeks post conception) after which they cause discolouration of the baby's teeth.
Demeclocycline, doxycycline, minocycline, tetracycline Category D
Aminoglycosides
There is evidence of selective uptake of aminoglycosides by the fetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the fetus. It should also be noted that therapeutic blood concentrations in the mother do not equate with safety for the fetus.
Amikacin, gentamicin, kanamycin, neomycin, netilmicin, tobramycin Category D
Antifungal Agents (See also Topical antifungals)
Amphotericin Category B3
Fluconazole Category D
Single dose therapy (150mg) does not appear to cause adverse pregnancy effects. Repeated doses of fluconazole (400-800mg daily) have been associated with a consistent pattern of birth defects similar to those seen in animal studies.
Flucytosine, griseofulvin, itraconazole, ketoconazole Category B3
Terbinafine Category B1
Nystatin Category A
Quinolones
Alatrofloxacin, ciprofloxacin, enoxacin, fleroxacin, norfloxacin, ofloxacin Category B3
Macrolide antibiotics
Azithromycin, roxithromycin Category B1
Clarithromycin Category B3
Erythromycin Category A
Miscellaneous antibiotics
Atovaquone, colistin IV, meropenem, metronidazole, vancomycin Category B2
Aztreonam, mupirocin, spectinomycin Category B1
Chloramphenicol, clindamycin, lincomycin, nalidixic acid Category A
Clavulanic acid Category B1
Fusidic acid Category C
This drug may cause kernicterus in babies during the first month of life by displacing bilirubin from plasma albumin. Fusidic acid should be avoided if possible during the last month of pregnancy.
Imipenem-cilastatin combination, teicoplanin, tinidazole Category B3
Nitrofurantoin (short term therapy) Category A
Caution should be exercised when administering nitrofurantoin at term because of the possibility of producing haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency and due to immature enzyme systems in the early neonatal period.
Pentamidine Category B3
Trimethoprim Category B3
Sulfonamides
Sulfonamides may cause jaundice and haemolytic anaemia in the newborn.
Sulfadoxine, sulfadiazine, sulfamethizole, sulfamethoxazole Category C
Trimethoprim-sulfonamide combinations Category C
Antituberculotics and antileprotics
Ethambutol, isoniazid Category A
Clofazimine Category C
Clofazimine may cause discolouration of the skin of the baby. This is reversible but recovery may be delayed because clofazimine has an average serum half life of 70 days.
Dapsone, pyrazinamide Category B2
Rifabutin Category C
Bleeding attributable to hypoprothrombinaemia has been reported in newborn infants and in mothers after the use of rifampicin during late pregnancy. If rifabutin is used during the last few weeks of pregnancy, vitamin K should be given to the mother and the newborn infant.
Rifampicin Category C
Bleeding attributable to hypoprothrombinaemia has been reported in newborn infants and in mothers after the use of rifampicin during late pregnancy. If rifampicin is used during the last few weeks of pregnancy, vitamin K should be given to the mother and the newborn infant.
Antimalarials
The use of these drugs in the treatment of malaria is accepted because the small risk to the fetus is outweighed by the benefits to the mother and fetus. Prophylaxis in high risk situations is also justified.
Chloroquine (prophylaxis) Category A
Chloroquine (treatment), hydroxychloroquine Category D
When used in high doses and for prolonged periods, chloroquine and related substances may cause neurological disturbances and interference with hearing, balance and vision in the fetus.
Doxycycline Category D
Tetracyclines are safe for use during the first 18 weeks of pregnancy (16 weeks post conception) after which they cause discolouration of the baby's teeth.
Mefloquine, pyrimethamine-dapsone combination Category B3
Primaquine phosphate Category D
Avoid use in third trimester as primaquine may cause neonatal haemolysis and methaemoglobinaemia.
Proguanil Category B2
If given during pregnancy, folic acid supplementation should be given. Proguanil has been used extensively with no adverse pregnancy outcome.
Pyrimethamine Category B3
This drug may interfere with folic acid metabolism and animal experiments have shown that administration of very high doses of pyrimethamine during organ development may give rise to birth defects typical of folic acid antagonism. If pyrimethamine is given during pregnancy, folic acid supplementation should be given.
Pyrimethamine-sulfadoxine combination Category C
Pyrimethamine may interfere with folic acid metabolism and if it is given during pregnancy folic acid supplementation should be given. Sulfonamides may cause jaundice and haemolytic anaemia in the newborn.
Quinine (treatment) Category D
In toxic doses, quinine causes fetal damage including deafness. Its ability to induce uterine contractions also constitutes a risk of abortion.
Antiviral agents
Aciclovir, indinavir, ritonavir, valaciclovir Category B3
Cidofovir Category D
This drug could be expected to cause fetal loss and birth defects.
Delavirdine, foscarnet, lamivudine, nevirapine, stavudine, zidovudine Category B3
Didanosine Category B2
Famciclovir, saquinavir Category B1
Ganciclovir Category D
This drug has been shown to be teratogenic and embryotoxic in animals.
Nelfinavir Category B2
Ribavirin Category X
Although there are no pertinent human data, ribavirin has been found to be teratogenic and/or embryolethal in nearly all species in which it has been tested. Malformations of skull, palate, eye, jaw, skeleton and gastrointestinal tract were noted in animal studies. Survival of fetuses and offspring was reduced.
Zalcitabine Category D
This drug is teratogenic in two animal species.
Anthelmintics
Albendazole Category D
In animal studies albendazole is teratogenic in several species. Until human data are available, it must be suspected of being teratogenic.
Ivermectin, mebendazole, thiabendazole Category B3
Praziquantel Category B1
Pyrantel embonate, diethylcarbamazine Category B2
Antineoplastic agents
Cytotoxic agents can produce spontaneous abortion, fetal loss and birth defects.
Alkylating agents
Busulfan, carmustine, chlorambucil, cyclophosphamide, estramustine, fotemustine, ifosfamide, lomustine, melphalan, mustine, thiotepa Category D
Antimetabolites
Cladribine, colaspase, cytarabine, docetaxel, fluorouracil, gemcitabine, hydroxyurea, methotrexate, mercaptopurine, paclitaxel, raltitrexed, thioguanine, topotecan Category D
Vinca alkaloids
Vinblastine, vincristine, vindesine, vinorelbine tartrate Category D
Antibiotic cytotoxic agents
Bleomycin, dactinomycin, daunorubicin, doxorubicin, epirubicin, fludarabine, idarubicin, mitomycin, mitozantrone Category D
Hormonal antineoplastic agents
Aminoglutethimide Category D
There have been reports of pseudohermaphrodism with use of this drug in pregnancy.
Anastrozole Category C
This drug disrupts oestrogen dependent metabolism and may result in abortion.
Goserelin, letrozole, leuprorelin Category D
There is a theoretical risk of abortion or fetal abnormality if GnRH agonists are used during pregnancy.
Medroxyprogesterone (oral and IM high dose) Category D
May cause virilisation of fetus if taken 8 weeks after conception.
Tamoxifen, toremifene Category B3
Other Antineoplastic agents
Altretamine, amsacrine, carboplatin, cisplatin, dacarbazine, etoposide, irinotecan, procarbazine, samarium[153 Sm], teniposide Category D
Tretinoin (Oral) Category X
This is a potent teratogen when taken systemically during early preganancy, producing a pattern of birth defects termed retinoic acid embryopathy. The teratogenic effect is dose-dependent.
Non-cytotoxic supportive therapy
Amifostine Category B3
Mesna Category B1
Metabolism
Anorectic and weight reducing agents
Weight reduction using appetite suppressant drugs is not recommended in pregnancy.
Dexfenfluramine, mazindol, phentermine Category B3
Diethylpropion, fenfluramine Category B2
Other drugs used for the treatment of metabolic disorders
Alglucerase, cysteamine bitartrate Category B3
Respiratory system
Antitussives
Opium alkaloids and derivatives: codeine, dextromethorphan, dihydrocodeine, pholcodine Category A
Expectorants and mucolytics
Acetylcysteine (inhaled) Category B2
Ammonium chloride, bromhexine, emetine, guaiphenesin, ipecacuanha, saponins Category A
Decongestants
Phenylephrine, phenylpropanolamine, pseudoephedrine Category B2
Inhalational agents
The agents that contain norflurane as the propellant have had limited human exposure. Norflurane has been shown to be safe in animals. The prescriber should consult the full pi for more information.
Bronchospasm relaxants
Eformoterol, salmeterol Category B3
Ephedrine, fenoterol, isoprenaline, orciprenaline, rimiterol, salbutamol, terbutaline, theophylline derivatives Category A
Ipratropium bromide Category B1
Preventive aerosols and inhalations
Beclomethasone, budesonide, fluticasone, salmeterol Category B3
The benefits of asthma control outweigh any potential for an adverse pregnancy outcome.
Nedocromil Category B1
Sodium cromoglycate Category A
Other respiratory agents
Acetylcysteine Category B2
Dornase alfa, montelukast, zafirlukast Category B1
Allergy and immune system
Antihistamines
Azatadine, cetirizine, diphenylpyraline, fexofenadine, methdilazine, terfenadine Category B2
Brompheniramine, chlorpheniramine, clemastine,cyproheptadine, dexchlorpheniramine, diphenhydramine, diphenylamine, doxylamine, pheniramine, triprolidine Category A
Chlorcyclizine, cyclizine, hydroxyzine Category A
Levocabastine Category B3
Inadvertent short term exposure during the first trimester is unlikely to cause a hazard to the fetus but it has been shown to be teratogenic in two species of animals and until human data are available, it should be suspected of being teratogenic.
Loratadine Category B1
Trimeprazine, promethazine Category C
When given in high doses during late pregnancy, phenothiazines have caused prolonged neurological disturbances in the infant.
Vaccines
Live attenuated virus vaccines
Currently available live virus vaccines have not caused teratogenic effects in humans. The NHMRC publication, The Australian Immunisation Procedures Handbook, should be consulted for more comprehensive information.
B.C.G., measles, measles-mumps, measles-mumps-rubella, mumps, typhoid (oral), yellow fever Category B2
Poliomyelitis (oral), typhoid (injection) Category A
Rubella Category B2
Women of child bearing age should be tested for rubella antibodies prior to pregnancy. All seronegative women, provided they are not pregnant, should be offered rubella vaccine. Those administering the vaccine should be careful to instruct women to whom it is given that they should not become pregnant for at least two full menstrual cycles because rubella vaccine can cause fetal infection. However, to date, there have not been any rubella-like birth defects in the live born infants (about 400) of seronegative mothers vaccinated during or just before pregnancy. Based on this experience, rubella vaccination during pregnancy need not be the reason to recommend interruption of pregnancy.
Killed vaccines
Cholera, haemophilus influenzae type B, hepatitis A, hepatitis B, influenza, meningococcal, pneumococcal, poliomyelitis (injection) Category B2
Diphtheria, tetanus Category A
Rabies vaccine Category B2
The benefit clearly outweighs the risk for post exposure situations.
Immunomodifiers
Azathioprine Category D
This drug has been associated with a slightly increased risk of fetal malformations, neonatal immunosuppression and bone marrow suppression in the infant.
Cyclosporin Category C
This drug may cause immunosuppression in the infant.
Interferon alpha-2a, interferon alpha-2b, interferon gamma-1b Category B3
Interferon beta-1a Category D
Interferon beta-1a has abortifacient activity in monkeys.
Interferon beta-1b Category D
This drug has abortifacient activity in monkeys. Spontaneous abortions have been reported in subjects with multiple sclerosis in controlled clinical trials.
Levamisole Category B3
Mycophenolate mofetil Category D
Mycophenolate has been shown to be teratogenic in two species of animals. It inhibits nucleic acid synthesis and may cause fetal malformations/death.
Rituximab Category C
Antibodies of this class are known to cross the fetoplacental barrier and may cause B cell depletion and/or other unknown effects.
Tacrolimus Category C
This drug may cause immunosuppression in the infant. Use of tacrolimus during pregnancy has been associated with neonatal hyperkalaemia and renal dysfunction.
Mouth preparations
Benzydamine (topical oropharyngeal) Category B2
Ophthalmic drugs
Acetazolamide, apraclonidine, dorzolamide, latanoprost, levocabastine Category B3
Betaxolol, levobunolol, timolol Category C
Beta-adrenergic blocking agents may cause pharmacological effects such as bradycardia in the fetus and newborn infant.
Brimonidine tartrate, lodoxamide trometamol Category B1
Chloramphenicol Category A
Ecothiopate Category B2
Flurbiprofen Category B2
Idoxuridine Category B3
Drugs used in dermatology
Systemic
Acitretin, etretinate Category X
These drugs are teratogenic at doses within the therapeutic range. They are stored in the body for several months after cessation. Because of the long half-life of these drugs and storage in fat, patients are advised not to conceive until two years after cessation of treatment because of risk of birth defects. Should pregnancy occur during treatment with these drugs, there is a high risk of birth defects.
Isotretinoin Category X
Isotretinoin is teratogenic and must not be used by females who are pregnant or who may possibly become pregnant while undergoing treatment and for one month after isotretinoin has stopped. Should pregnancy occur during treatment with this drug, there is a high risk of birth defects (refer to current Product Information).
Topical
Adapalene Category D
There have been isolated reports of birth defects in babies born to women using this drug. Because of the potential risk of adverse effects on fetal development, adapalene should not be used by women who are pregnant or who plan to become pregnant during treatment.
Azelaic acid, calcipotriol Category B1
Desonide Category B3
Finasteride Category X
Finasteride may cause abnormalities of the external genitalia of a male fetus.
Isotretinoin Category D
Isotretinoin is known to be teratogenic when administered orally in human beings. It is associated with major birth defects and with a small risk of spontaneous abortion.
Methoxsalen Category B2
Tretinoin Category D
Use of tretinoin cream formulation during the first trimester does not appear to cause birth defects. Other formulations should not be used during pregnancy. There have been isolated reports of birth defects in babies born to women using topical tretinoin in pregnancy, some similar to those reported with oral retinoids. While a retrospective cohort study on women exposed to tretinoin in the first trimester did not reveal an association with this treatment, the numbers in this study are too small to establish the safety of use in pregnancy.
Topical antifungals, antiseptics
Amorolfine, bifonazole, Category B3
Cetylpyridinium, chlorhexidine, chlorquinaldol, clotrimazole, econazole, hydroxyquinoline, miconazole Category A
Topical antiparasitics
Benzyl benzoate, bioallethrin, crotamiton, maldison (malathion), permethrin, pyrethrins Category B2
Lindane Category B3
Lindane penetrates human skin and has been reported to cause signs of CNS irritation. Because of this toxic potential it is preferable, whenever possible, to use other medications during pregnancy.
Piperonyl butoxide Category B3
Topical antiviral
Aciclovir Category B3
Idoxuridine, imiquimod, penciclovir Category B1
Drugs used in anaesthesia
General anaesthetics
All general anaesthetics carry the potential to produce central nervous system and respiratory depression in the newborn infant. In routine practice this does not appear to be a problem. However, in the compromised fetus, careful consideration should be given to this potential depression and to the selection of particular anaesthetic drugs, doses and techniques.
Enflurane, halothane, ketamine, thiopentone Category A
Desflurane, isoflurane Category B3
Methohexitone, sevoflurane Category B2
Methoxyflurane Category C
Nitrous oxide Category A
Propofol Category C
Local anaesthetics
Bupivacaine, cinchocaine, lignocaine, mepivacaine, prilocaine Category A
Etidocaine, ropivacaine Category B1
Procaine hydrochloride Category B2
Neuromuscular blocking agents
Alcuronium, mivacurium, pancuronium, rocuronium Category B2
Atracurium, gallamine, pipecuronium, tubocurarine, vecuronium Category C
There have been no demonstrated adverse effects in the fetus or the newborn infant.
Suxamethonium Category A
Medroxyprogesterone (IM contraceptive dose) Category A
Contraceptive agents
Oral contraceptives
Combined, progestogen only Category B3
Accumulated evidence reports that inadvertent exposure to these agents in early pregnancy has not been associated with an increased risk of birth defects.
Vaginal spermicides
Nonoxynol 9, octoxinol Category A
If a radiological contrast or other diagnostic agent is not in this booklet refer to the product information or contact an obstetric drug information service (see Appendix B).
Diagnostic agents
sodium phosphate [32P] Category X
Technetium [99mTc] bicisate dihydrochloride kit, [99mTc] exametazine injection Category C
Radiographic Agents
Ioversol Category B1
Gadodiamide, iomeprol Category B3
Galactose and palmitic acid Category B2
Pituitary-adrenal response test
Metyrapone Category B2
Tetracosactrin Category D
There have been some reports of miscarriage or fetal malformation occurring in pregnant women treated with tetracosactrin.
Miscellaneous
Detoxifying agents, antidotes
Acetylcysteine (intravenous), digoxin immune fab Category B2
Desferrioxamine, flumazenil Category B3
Naloxone Category B1
Penicillamine Category D
Penicillamine can cause cutis laxa in the human fetus.
Cholinergic and anticholinergic agents
Atropine, hyoscine methobromide, papaverine Category A
Atropine methonitrate, belladonna, glycopyrrolate, hyoscine, hyoscine-N-butylbromide, hyoscyamine, propantheline Category B2
Bethanechol Category B2
This drug has a potent excitatory effect on smooth muscle and should be avoided during pregnancy.
Donepezil Category B3
Tacrine Category C
This drug may produce cholinergic effects in the fetus.
Drugs used in myasthenia gravis
Ambenonium chloride, neostigmine Category B2
Pyridostigmine Category C
The maternal requirement for this drug in the context of myasthenia gravis may be absolute. Cholinergic effects in the neonate are rare.
Agents used in dependency states
Calcium carbimide Category A
Disulfiram Category B2
Methadone Category C
Narcotic analgesics may cause respiratory depression in the newborn infant. Withdrawal symptoms in newborn infants have been reported with prolonged use of this drug.
Naltrexone Category B3
Nicotine
- transdermal Category D
- in chewing gum Category D
The harmful effects of cigarette smoking on maternal and fetal health are clearly established. The specific effects of nicotine therapy on fetal development are unknown. Short-term exposure during the first trimester is unlikely to cause a hazard to the fetus.
Vitamins
Nicotinic acid Category B2
Vitamin A Category D
Excess vitamin A may cause birth defects. Women should consider their dietary intake of vitamin A before taking supplements. The Australian diet usually contains the recommended daily allowance of 2500 IU.
The Australian categorisation consists of the following categories:
Category A
Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
Category C
Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
Category B1
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have not shown evidence of an increased occurrence of fetal damage.
Category B2
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
Category B3
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
Category D
Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
Category X
Drugs which have such a high risk of causing permanent damage to the fetus that they should not be used in pregnancy or when there is a possibility of pregnancy.
Note: For drugs in the B1, B2 and B3 categories, human data are lacking or inadequate and subcategorisation is therefore based on available animal data. Drugs in category D are not absolutely contraindicated in pregnancy (e.g. anticonvulsants). Moreover, in some cases the 'D' category has been assigned on the basis of 'suspicion'.
Due to legal considerations in this country, sponsor companies have, in some cases, applied a more restrictive category than can be justified on the basis of the available data.
In some cases there may be discrepancies between the published Product Information and the information in this booklet due to the process of ongoing document revision.