Benzphetamine Pregnancy and Breastfeeding Warnings

Brand names: Didrex, Recede, Regimex

Medically reviewed by Drugs.com. Last updated on Jul 24, 2025.

Benzphetamine Pregnancy Warnings

Use is contraindicated.

US FDA pregnancy categories:
-Oral, 25 mg tablets: X
-Oral, 50 mg tablets: Not assigned.

Risk summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant patient.

Comment:
-The patient should be apprised of the potential hazard to the fetus if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug.

Animal studies conducted with amphetamines administered at doses in high multiples of the human dose have revealed evidence of teratogenicity and embryotoxicity. There are no controlled data in human pregnancy.

US FDA pregnancy 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.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Benzphetamine Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes

Comments:
-The effect of amphetamine in milk on the neurological development of the breastfed infant has not been well studied.
-Large dosages of amphetamine might interfere with milk production, especially in women whose lactation is not well established.

-Amphetamine was measured in a 12-hour urine collection in a breastfed infant whose mother was taking racemic amphetamine 5 mg four times daily. The infant's urinary excretion of amphetamine ranged from 0.1% to 0.3% of the mother's urinary excretion; this infant showed no signs of abnormal development during the first 2 years of life.
-A study that involved 20 postpartum women revealed evidence that amphetamines may affect serum prolactin levels. A 7.5 mg dose of dextroamphetamine reduced serum prolactin by 25% to 32%, and the 15 mg dose decreased serum prolactin by 30% to 37%. Another study of postpartum women showed a 20 mg dose of dextroamphetamine produced a sustained suppression of serum prolactin by 40%.
-The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

See references

Further information

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