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The following tables summarize safety of drug use in pregnancy and lactation.
Medications of herbal origin are excluded from the list.
Under the column "Drug-Pregnancy Categories", letters A, B, C, D, and X signify the FDA Pregnancy
categories.
These five categories indicate the potential of a systemically-absorbed drug to cause birth defects;
the key differentiation among the categories rests upon the reliability of documentation and the
risk: benefit ratio.
A : Controlled studies in pregnant women fail to demonstrate a risk to the fetus in the first
trimester with no evidence of risk in later trimesters. The possibility of fetal harm
appears remote.
B : Either animal-reproductive studies have not demonstrated a fetal risk but there are no
controlled studies in pregnant women, or animal-reproduction studies have shown an
adverse effect (other than a decrease in fertility) that was not confirmed in controlled
studies in women in the first trimester and there is no evidence of risk in later
trimesters.
C : Either studies in animals have revealed adverse effects on the fetus (teratogenic or
embryocidal effects or other) and there are no controlled studies in women, or studies
in women and animals are not available. Drugs should be given only if the potential
benefits justify the potential risk to the fetus.
D : There is positive evidence of human fetal risk, but the benefit from use in pregnant
women may be acceptable despite the risk (If the drug is needed for life threatening
situations or for serious diseases for which safer drugs can not be used or are
ineffective).
X : Studies in animals or human beings have demonstrated fetal abnormalities or there is
evidence of fetal risk based on human experience, or both, and the risk of the use of the
drug in pregnant women clearly outweighs any possible benefit. The drug is
contraindicated in women who are or may become pregnant.
For drugs not FDA approved; other classification systems were used to identify the pregnancy
categories, whenever possible, the two other systems used are:
1. Micromedex Pregnancy Ratings:
Fetal risk has been Evidence has demonstrated fetal abnormalities or risks when used
demonstrated during pregnancy or in women of childbearing potential. An
alternative to this drug should be prescribed during pregnancy or
in women of childbearing potential.
Fetal risk is minimal The weight of an adequate body of evidence suggests this drug
poses minimal risk when used in pregnant women or women of
childbearing potential.
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.
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.
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.
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
Note: For drugs in the B1, B2 and B3 categories, human data are lacking or inadequate and sub-
categorization is therefore based on available animal data. The allocation of a B category does not
imply greater safety than the C category. 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'.
If there was no data under the previous three categorizations, the drug-pregnancy category is
assigned as "N/A"
Data for medication use during breast feeding, are complied from FDA data, WHO data and
Micromedex Lactation Ratings:
1. WHO Lactation Ratings:
Avoid breastfeeding
Avoid breastfeeding if possible. May inhibit lactation
Avoid breastfeeding if possible. Monitor infant for side effects
Compatible with breastfeeding
Compatible with breastfeeding. Monitor infant for side effects
WHO documentation states insufficient data
Infant risk has been Evidence and/or expert consensus has demonstrated harmful
demonstrated infant effects when used during breastfeeding. An alternative to
this drug should be prescribed or patients should be advised to
discontinue breastfeeding.
Infant risk is minimal The weight of an adequate body of evidence and/or expert
consensus suggests this drug poses minimal risk to the infant when
used during breastfeeding
Milk effects are Evidence suggests this drug may alter milk production or
possible composition. If an alternative to this drug is not prescribed,
monitor the infant for adverse effects and/or adequate milk intake
recommended
Doxycycline D Excreted in breast milk/not recommended
Duloxetine C Excreted in breast milk/use caution
Excretion in breast milk
Dutasteride X
unknown/contraindicated
Excretion in breast milk unknown/not
Dydrogesterone No data available
recommended
Excretion in breast milk unknown/use
Econazole C
caution
Eletriptan C Excreted in breast milk/use caution
Enalapril D Excreted in breast milk/not recommended
Enalapril and Refer to Individual
Refer to Individual Agents
Hydrochlorothiazide Agents
Excretion in breast milk unknown/not
Enoxaparin B
recommended
Excretion in breast milk unknown/not
Entecavir (P) C
recommended
Excretion in breast milk unknown/use
Epinastine C
caution
EPINEPHrine (Systemic, Oral Excretion in breast milk unknown/use
C
Inhalation) caution
Excretion in breast milk unknown/not
Epirubicin D
recommended
Excretion in breast milk unknown/not
Eprosartan D
recommended
Eprosartan/Hydrochlorothiazide D Excreted in breast milk/not recommended
Eptacog Alfa Factor VIIa Excretion in breast milk unknown/not
C
(Recombinant) recommended
Excretion in breast milk unknown/not
Eribulin D
recommended
Excretion in breast milk unknown/not
ERLOtinib D
recommended
Ertapenem B Excreted in breast milk/use caution
Excretion in breast milk unknown/use
Erythromycin (Ophthalmic) B
caution
Erythromycin (Systemic) B Excreted in breast milk/use caution
Excretion in breast milk unknown/use
Erythropoietin /Epoetin Alpha C
caution
Generic Name Pregnancy Category Breast Feeding Considerations
Escitalopram C Excreted in breast milk/consider
risk:benefit
Excretion in breast milk unknown/not
Esmolol C
recommended
Esomeprazole C Excreted in breast milk/use caution
Estradiol (Systemic) X Excreted in breast milk/use caution
Estradiol (Systemic) No data available Excreted in breast milk/use caution
Etanercept B Excreted in breast milk/use caution
Ethambutol C Excreted in breast milk/use caution
Ethamsylate No data available No data available
Ethinylestradiol [Ethinyl
X Excreted in breast milk/not recommended
Estradiol] and Desogestrel
Ethinylestradiol [Ethinyl
X Excreted in breast milk/not recommended
Estradiol] and Drospirenone
Ethinylestradiol [Ethinyl
X Excreted in breast milk/not recommended
Estradiol] and Etonogestrel
Ethinylestradiol [Ethinyl
X Excreted in breast milk/not recommended
Estradiol] and Norelgestromin
Excretion in breast milk unknown/use
Etomidate C
caution
MPR: Fetal risk
Etonogestrel Excreted in breast milk/use caution
cannot be ruled out
Excretion in breast milk unknown/not
Etoposide D
recommended
C (Prior to 30 weeks
Excretion in breast milk
Etoricoxib gestation)/D (≥30
unknown/contraindicated
weeks gestation)
D (Afinitor®)/C Excretion in breast milk unknown/not
Everolimus
(Zortress®) recommended
Excretion in breast milk unknown/not
Exemestane X
recommended
Excretion in breast milk unknown/use
Exenatide (P) C
caution
Excretion in breast milk unknown/not
Ezetimibe C
recommended
Refer to Individual
Ezetimibe and Simvastatin Refer to Individual Agents
Agents
Factor IX (Human) C No data available
Excretion in breast milk unknown/not
Famciclovir B
recommended
Generic Name Pregnancy Category Breast Feeding Considerations