15/10/2023
FDA Pregnancy Categories
Category A
Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
Category B
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Category C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category D
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category X
Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits
Category A Drugs
Thiamine, Pyridoxine, Folic acid
Docusate, Senna, Bisacodyl
Dextromethorphan
Doxylamine
Levothyroxine
Isoniazid
Category B Drugs
Antibiotics
Penicillin V, Penicillin G Benzathine, Amoxicillin, Amoxicillin/Clavulanate, Oxacillin, Ampicillin, Ampicillin/Sulbactam, Ticarcillin/Clavulanate, Dicloxacillin, Cloxacillin, Nafcillin
Ceftriaxone, Cephalexin, Cefazolin, Cefepime, Cefuroxime, Ceftaroline fosamil, Cefdinir, Cefadroxil, Cefpodoxime, Cefprozil, Ceftolozane/tazobactam, Cefditoren
Clindamycin, Azithromycin, Erythromycin, Fidaxomicin, Spiramycin
Metronidazole
Daptomycin
Nitrofurantoin, Fosfomycin
Aztreonam, Meropenem, Ertapenem, Doripenem
Mupirocin
Quinupristin/dalfopristin
Other Antimicrobials
Acyclovir, Famciclovir
Valacyclovir
Amphotericin B
Clotrimazole (topical, vulvovaginal)
Terbinafine
Mefloquine
Permethrin
Emtricitabine/tenofovir (Truvada)
Nitazoxanide
Praziquantel
Raxibacumab
Antiemetics and other GI medications
Metoclopramide
Ondansetron
Dimenhydrinate
Famotidine
Lansoprazole, Pantoprazole
Lactulose, Psyllium
Loperamide
Dicyclomine
Ursodiol
Sucralfate
Analgesics and other neuro/psych meds
Acetaminophen
Ketamine
Meperidine
Cyclobenzaprine
Indomethacin
Meclizine
Clozapine
Benztropine
Buspirone
Methylphenidate
Cardiovascular Medications
Hydrochlorothiazide
Fenoldopam
Torsemide, Ethacrynic acid, Amiloride
Epoprostenol (prostacyclin)
Sildenafil
Dobutamine
Sotalol
Antiplatelet and Anticoagulants
Clopidogrel, Prasugrel
Eptifibatide
Ticlopidine
Tirofiban
Apixaban
Argatroban, Bivalirudin
Fondaparinux
Enoxaparin
Antidotes
EDTA
Levocarnitine
Cyproheptadine
Idarucizumab
N-acetylcysteine
Miscellaneous
Ipratropium, Budesonide
Ranitidine, Cimetidine
Metformin
Oxybutynin, Tamsulosin, Phenazopyridine
Bromocriptine
Glycopyrrolate
Montelukast
Desmopressin
Glucagon
Prilocaine
Propofol
Sodium polystyrene sulfonate
Sulfasalazine
Category C Drugs
Includes most medications not listed elsewhere here
Category D Drugs
Antimicrobials
Gentamicin, Neomycin, Amikacin, Streptomycin, Kanamycin
Trimethoprim-sulfamethoxazole
Doxycycline, Minocycline, Tetracycline, Tigecycline
Fluconazole, Voriconazole
Primaquine, Hydroxychloroquine
AEDs and other neuro/psych meds
Phenytoin, Fosphenytoin
Carbamazepine
Midazolam, Alprazolam, Clonazepam, Diazepam
Phenobarbital
Magnesium sulfate (despite being drug-of-choice for eclampsia!)
Lithium
Topiramate
Pentobarbital
Cardiovascular
Amiodarone
Atenolol
Lisinopril, Captopril, Enalapril, Benazepril
Losartan, Valsartan
Aspirin (3rd trimester)
Edoxaban
Warfarin
Miscellaneous
Cortisone, Flunisolide
Mycophenolate mofetil
Penicillamine
Methimazole, Propylthiouracil, Potassium iodide
Hydroxyurea
Zoledronate
Bismuth subsalicylate (3rd trimester only)
Cyclophosphamide
Ibuprofen (3rd trimester only, otherwise category C)
Meloxicam (if >30wks, otherwise category C)
Tamoxifen
Category X Drugs
Valproate
Methotrexate
Ribavirin
Triazolam
Bosentan
Aliskiren
Emergency contraception: Levonorgestrel, Ulipristal
Griseofulvin
Methylene blue
Oxytocin
Riociguat
Isotretinoin
