Condition |
FDA Pregnancy Category |
Comments |
Acne |
|
Adapalene |
C |
No malformations seen in animal studies, but no well-controlled human trials available |
|
Isotretinoin |
X |
Absolute contraindication, no safe dose, monthly pregnancy testing and two forms of contraception are required throughout therapy |
|
Tazarotene |
X |
Absolute contraindication, negative pregnancy test should be obtained 2 weeks before therapy initiation |
|
Tretinoin |
C |
Case reports of malformations with topical administration during the first trimester |
Anti-infectives |
|
Aminoglycosides |
D |
Streptomycin and kanamycin have been reported to cause congenital deafness. Serious side effects in the fetus have not been reported with other aminoglycosides |
|
Azithromycin |
B |
No evidence of congenital defects |
|
Cephalosporins |
B |
Less data than with penicillins, but generally considered safe in pregnancy |
|
Daptomycin |
B |
Unknown risk to the fetus because of limited safety data |
|
Erythromycin |
B |
The base is considered safe for use during pregnancy. No significant evidence of congenital defects reported. The estolate salt has been reported to cause hepatotoxicity in pregnant women |
|
Linezolid |
C |
Unknown risk to the fetus because of limited safety data |
|
Metronidazole |
B |
No compelling evidence of fetal harm. Recommended by CDC for treatment of trichomoniasis and bacterial vaginosis during pregnancy. Manufacturer lists first trimester use as a contraindication |
|
Nitrofurantoin |
B |
Considered safe. Theoretically, could cause hemolytic anemia in newborn. Avoid in bacteremia, urosepsis, and pyelonephritis |
|
Penicillins |
B |
Generally considered safe in pregnancy. Most safety experience with penicillin G |
|
Quinupristin/dalfopristin |
C |
Unknown risk to the fetus due to limited safety data |
|
Quinolones |
C |
Avoid use during pregnancy. Have been associated with arthropathies in animals and children |
|
Tetracyclines |
D |
Avoid if possible, especially during last half of pregnancy |
|
Trimethoprim/Sulfamethoxazole |
C |
Trimethoprim inhibits folic acid synthesis. Sulfonamides can induce kernicterus in the newborn if used late in pregnancy |
|
Vancomycin |
C |
Generally not thought to be teratogenic. Links to ototoxicity and nephrotoxicity not established |
Analgesia |
|
Acetaminophen |
B |
Analgesic and antipyretic of choice in pregnancy |
|
Aspirin |
C |
May produce adverse effects in the mother and the fetus. Can inhibit labor if used late in pregnancy. Avoid if possible |
|
Codeine |
C/D |
High doses or long term use is not recommended. Likely to cause neonatal respiratory depression and withdrawal if used near term |
|
Nonsteroidal anti-inflammatories |
B/C/D |
No association to date with congenital malformations. Can theoretically inhibit labor if used late in pregnancy. May cause constriction or closure of the ductus arteriosus if used near term |
|
Hydromorphone |
B/D |
Not associated with congenital defects. High doses or long-term use is not recommended. Likely to cause neonatal respiratory depression and withdrawal if used near term |
|
Fentanyl |
C/D |
Not associated with congenital defects. Likely to cause neonatal respiratory depression and withdrawal if used near term |
|
Morphine |
C/D |
Not associated with congenital defects. High doses or long-term use is not recommended. Likely to cause neonatal respiratory depression and withdrawal if used near term |
|
Oxycodone |
B/D |
Not associated with teratogenic effects. High doses or long-term use is not recommended. Likely to cause neonatal respiratory depression and withdrawal if used near term |
Asthma |
|
β-Agonists |
C |
Safety differences between agents have not been identified. Oral/parenteral agents may delay delivery based on alternative indications (i.e., preterm labor) |
|
Corticosteroids |
C |
Inhaled budesonide is preferred. ACOG does not mandate change from prior inhaled steroid agent despite category |
|
Inhaled anticholinergics |
B |
No reports of teratogenicity in animals exposed to ipratropium, but few human investigations. No well-controlled studies in humans with tiotropium |
|
Leukotriene receptor antagonists |
B |
No long-term data for this newer therapeutic class |
|
Theophylline |
C |
Does not appear teratogenic. Drug clearance may be altered in pregnancy, monitor dose |
Coagulation |
|
Coumarin derivatives (warfarin) |
X |
Generally considered contraindicated. Risks include embryopathy, spontaneous abortion, stillbirth, prematurity, and hemorrhage |
|
Heparin |
C |
Generally considered the agent of choice in pregnancy. Long-term therapy has been linked to maternal osteopenia |
|
Low molecular weight heparins |
B |
Alternative therapy to UFH. Use of enoxaparin in pregnant women with a mechanical heart valve is controversial due to valvular clotting and deaths reported in clinical trial and post-marketing surveillance |
|
Fondaparinux |
B |
Synthetic factor Xa inhibitor used in patients with heparin allergy or heparin |
Depression |
|
Monoamine oxidase inhibitors |
C |
Limited human data for pregnancy. Maybe increased risk for malformations; risk of use must be weighed against benefits |
|
Selective serotonin reuptake inhibitors (SSRIs) (Paroxetine = D) |
C |
Most experience with fluoxetine with no associated teratogenicity. Neonatal withdrawal syndrome has been estimated to occur in 30% of infants. Paroxetine use has been linked to cardiac malformations and PPHN |
|
Tricyclic antidepressants (TCAs) Imipramine = D |
C |
This drug class may be associated with neonatal withdrawal (colic, cyanosis, tachypnea, and irritability). Animal trials and human case reports have documented congenital abnormalities with imipramine |
|
Newer Antidepressants Bupropion = B Duloxetine = C Mirtazapine = C Nefaxodone = C Trazodone = Venlafaxine = C |
B/C |
Limited human data available for more recently approved agents. May consider for women refractory to other agents |
Diabetes |
|
Glyburide |
C |
One large prospective study has found that glyburide is as effective as insulin in women after the first trimester with gestational diabetes. Glyburide is a reasonable alternative to insulin in certain patients (e.g., fear of needles/injections) |
|
Insulin (human), short-acting |
|
Regular insulin is the agent of choice in pregnancy. Insulin aspart and lispro are alternatives for better postprandial glucose control. No human data available for glulisine |
|
|
Regular |
B |
|
|
|
Aspart |
B |
|
|
|
Lispro |
B |
|
|
|
Glulisine |
C |
|
|
Insulin (human), long-acting |
|
NPH insulin is the basal insulin agent of choice in pregnancy. Limited pregnancy data available for insulin glargine and detemir (peak-less insulins); clinical implications of their increase in IGF-1 receptor affinity unknown |
|
|
NPH |
Not available |
|
|
Detemir |
C |
|
|
|
Glargine |
C |
|
|
Metformin |
B |
No morphological abnormalities observed in animals but some conflicting human data; results of one large clinical trial found metformin (with supplemental insulin) to be as effective and safe as insulin alone for gestational diabetes (after first trimester). PCOS clinical trials demonstrate safety. More research needed |
Gastrointestinal Reflux |
|
Aluminum-containing antacids |
Not available |
Use is controversial. Severe developmental retardation reported in a child after high-dose use during pregnancy; normal doses during pregnancy may be acceptable. Co-ingestion of acidic foods or beverages should be avoided due to potential for increased GI absorption of aluminum |
|
Calcium/Magnesium-containing antacids |
Not available |
Generally considered first-line therapy for GERD in pregnancy; 10%-30% of calcium, 15%-30% of magnesium is absorbed |
|
H2 Receptor Antagonists |
|
|
Cimetidine |
B |
Antiandrogenic effects observed in animals and nonpregnant humans; Limited data in humans suggest no association with increased risk of malformations |
|
|
Ranitidine |
B |
Only H2RA with documented efficacy in pregnancy; available evidence suggests no congenital malformations or neonatal toxicity |
|
|
Famotidine |
B |
Limited safety data in humans |
|
|
Nizatidine |
B |
Caution recommended during pregnancy due to reports of abortions, low fetal weights, and fewer live fetuses in rabbits at doses significantly higher than recommended human doses |
|
Magnesium trisilicates |
Not available |
Avoid long-term, high-dose use due to potential for fetal nephrolithiasis, hypotonia, respiratory distress, and cardiovascular effects |
|
Proton Pump Inhibitors |
|
Omeprazole |
C |
Reports regarding use in pregnancy are conflicting; use of safer alternatives preferred whenever possible (especially in the first trimester) |
|
|
Lansoprazole |
B |
Limited clinical experience available in humans. Use of safer alternatives preferred whenever possible (especially in the first trimester) |
|
|
Rabeprazole |
|
|
|
|
Pantoprazole |
|
|
|
|
Esomeprazole |
|
|
|
Metoclopromide |
B |
Available evidence suggests no congenital malformations or neonatal toxicity |
|
Sodium bicarbonate |
Not available |
Avoid in pregnancy due to potential for maternal/fetal fluid overload and potential for metabolic alkalosis |
|
Sucralfate |
B |
No data in animals, generally considered acceptable in pregnancy due to low absorption; Potential for fetal toxicity linked to aluminum content (1 g sucralfate = 207 mg aluminum) |
Hypertension |
|
Angiotensin-converting enzyme inhibitors (ACEIs) |
D |
Contraindicated in pregnancy. Can cause fetal toxicity and death |
|
Angiotensin II receptor antagonists |
D |
Contraindicated. Similar to ACEIs |
|
β-Blockers |
C |
Generally considered safe, but may be associated with fetal growth retardation |
|
Calcium antagonists nifedipine |
C |
Limited data. No increase in major teratogenicity noted, but generally not used due to its association with cardiovascular events. Nifedipine use is controversial |
|
Diuretics |
B/C |
Probably safe, but not first-line agents. Furosemide is embryotoxic. Thiazide diuretics considered safest in this class |
|
Hydralazine |
C |
May be used as first or second line for acute hypertensive crisis, but second line after methyldopa for chronic treatment during pregnancy |
|
Labetalol |
C |
May be used as first or second line for acute hypertensive crisis, but second line after methyldopa for chronic treatment during pregnancy. Should not be used in those with asthma or congestive heart failure |
|
Methyldopa |
B |
Preferred agent for chronic hypertension during pregnancy. No adverse effects noted in long term follow-up study |
Migraine/Headache |
|
Dihydroergotamine |
X |
Contraindicated. Has been linked to perinatal deaths and abnormalities |
|
Ergotamine |
X |
Contraindicated. Has been linked to perinatal deaths and abnormalities |
|
Sumatriptan |
C |
Not thought to be a human teratogen. Exposures, including those in the first trimester, linked to preterm labor and low birth weight infants |
Nausea and Vomiting |
|
Dimenhydrinate |
B |
Limited data available. Congenital defects were not found to be associated with dimenhydrinate |
|
Diphenhydramine |
B |
Avoid near delivery |
|
Doxylamine |
A |
Effective in combination with pyridoxine |
|
Hydroxyzine |
C |
Given orally or IM. Possible congenital defects when given in first trimester |
|
Meclizine |
B |
Several studies show safety in pregnancy |
|
Metoclopramide |
B |
Enhances upper GI tract motility, increases lower esophageal sphincter tone, and in high doses, blocks serotonin in CTZ. EPS may be seen |
|
Ondansetron |
B |
Blocks serotonin peripherally and in the CTZ |
|
Promethazine |
C |
Safety data are conflicting. Use in labor is common, however, limited data regarding its use for NVP |
|
Pyridoxine |
A |
Effective in combination with doxylamine |
Psychosis and Bipolar Disorder |
|
Benzodiazepines |
C |
Sedation and withdrawal seen in the neonate. Floppy infant syndrome (hypotonia, low Apgar scores, and neurological depression) |
|
|
|
D (near term) |
|
Low-potency antipsychotics Chlorpromazine Thioridazine |
C |
Tachycardia, GI dysfunction, sedation, and hypotension seen at birth and up to several days after delivery. Exposure during weeks 4-10 of gestation associated with increased risk of malformations. Chlorpromazine may cause insulin resistance in mother and respiratory depression in the newborn exposed during the third trimester. Dose reduction near term can be considered to reduce risk of toxicity in infant |
|
High-potency antipsychotics Fluphenazine Perphenazine Trifluoperazine Thiothixine Haloperidol |
C |
Extrapyramidal side effects (hyperactivity, tremor, hyperactive deep tendon reflexes, restlessness, abnormal movements, increased muscle tone, vigorous rooting or sucking, arching of back, and shrill crying) seen in newborn (especially if mother is given high doses). Exposure during weeks 4-10 of gestation associated with increased risk of malformations. Dose reduction near term can be considered to reduce risk of toxicity in the infant. Two case reports of limb reduction when haloperidol was administered in the first trimester; however, other studies have not confirmed this association |
|
Atypical Antipsychotics Clozapine |
B |
No defects seen in animals; one case report of intrauterine fetal death; accumulation of clozapine in neonate theoretically linked to floppy infant syndrome, neonatal seizures, gastrointestinal reflux disease, and agranulocytosis. Monitoring of white blood cells in newborns can be considered. Potential risk for gestational diabetes in mother |
|
|
Olanzapine |
C |
Potential risk for gestational diabetes in mother; Limited data suggest olanzapine does not increase fetal teratogenic risk or rates of spontaneous abortion, however, more data are needed |
|
|
Risperidone, Quetiapine, Ziprasidone |
C |
Data for these agents are limited or absent; ziprasidone is associated with developmental delays, possible teratogenic effects, and increased stillbirths in animals; however, limited human data are available |
|
|
Lithium |
D |
Based on voluntary Register of Lithium Babies: higher rate of cardiovascular malformation (Ebstein’s Anomaly); “floppy baby” syndrome (cyanosis and hypotonicity) common with exposure during labor; hypothyroidism and nephrogenic diabetes insipidus have been observed |
Seizure |
|
Carbamazepine |
D |
Estimated 1% risk of spina bifida; craniofacial defects, developmental delay (rate may be as high as 20%), may lessen effectiveness of contraceptives |
|
Gabapentin |
C |
Gabapentin: No pattern of malformations reported to date, but often used with other agents, making causal determination difficult |
|
Lamotrigine |
C |
Lamotrigine: may cause nervous system, heart, craniofacial, skeletal and urinary tract defects (Australian Birth Registry data) |
|
Levetiracetam |
C |
Levatiracetam: no malformations or developmental delay reported in limited human evaluations |
|
Oxcarbazepine |
C |
Oxcarbazepine: no major malformations reported to date; however, similar structure to carbamazepine which may cause neuronal tube defects; may lessen effectiveness of contraceptives |
|
Phenobarbital |
D |
Congenital heart defects, facial clefts, dysmorphic features, fetal withdrawal syndrome, may lessen effectiveness of contraceptives |
|
Phenytoin |
D |
Cleft palate, dysmorphic features, and craniofacial abnormalities; may lessen effectiveness of contraceptives |
|
Primidone |
D |
Neonatal hemorrhagic syndrome, neural tube defects, may lessen effectiveness of contraceptives |
|
Topiramate |
C |
Topiramate: developmental delay and teratogenicity in animal studies, may lessen effectiveness of contraceptives |
|
Valproic Acid and salt derivatives |
D |
Doses >1,000 mg/d may heighten risk for spina bifida; other effects: dysmorphic features, developmental delay, cardiovascular and urogenital malformations |
Herbal Products |
|
Ginkgo biloba |
Not applicable |
Ginkgo not recommended for use during pregnancy due to lack of standardization of products and need for further studies. No published evidence of major birth defects; however, more studies needed |
|
Mugwort, Blue Cohash, Tansy, Black Cohosh, Scotch Broom, Goldenseal, Juniper Berry, Pennyroyal Oil, Rue, Mistletoe, and Chaste Berry |
Not applicable |
All are considered uterine stimulants or abortifacients and therefore contraindicated in pregnancy |
|
Echinacea |
Not applicable |
Echinacea cannot be recommended for use during pregnancy, due to lack of standardization of products and need for further studies |
|
St. John’s wort |
Not applicable |
No studies regarding reproductive toxicity; animal studies suggest slight uterotonic activity. Due to lack of standardization of products and need for further studies, St. John’s wort cannot be recommended for use during pregnancy |
|
Ginger |
Not applicable |
Use could affect testosterone receptor binding in the fetus; use is controversial and not recommended |
|
Ginseng |
B |
Associated with hypertension and hypoglycemia in the mother |