Dichlorphenamide Pregnancy and Breastfeeding Warnings

Brand names: Daranide, Keveyis, Ormalvi

Medically reviewed by Drugs.com. Last updated on Feb 17, 2025.

Dichlorphenamide Pregnancy Warnings

This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: Based on animal data, this drug may cause fetal harm; animal studies have revealed evidence of teratogenicity. Inadequate data available on the use of this drug in pregnant women to inform of a drug-related risk.

Teratogenic effects (fetal limb reduction defects) were reported following oral administration of this drug in pregnant animals during organogenesis at 350 mg/kg, or 17 times the maximum recommended human dose (200 mg/day) on a body surface area (mg/m2) basis. A no-effect dose has not been established. There are no adequate and well-controlled studies in pregnant women.

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

Dichlorphenamide Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comment:
-The effects in the nursing infant are unknown.

See references

Further information

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