Salsalate Pregnancy and Breastfeeding Warnings

Brand names: Amigesic, Anaflex, Argesic-SA, Disalcid, Marthritic, Mono-Gesic, Salflex, Salsitab

Medically reviewed by Drugs.com. Last updated on Oct 24, 2024.

Salsalate Pregnancy Warnings

Use should be avoided during the third trimester of pregnancy.
Prior to third trimester: Use only if potential benefit justifies the potential risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk Summary: Nonsteroidal anti-inflammatory drugs (NSAIDs) use in pregnant patients at 30 weeks gestation and later may cause premature closure of the fetal ductus arteriosus; NSAID use at 20 weeks gestation or later may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment.

Comments:
-If NSAID use is necessary between 20- and 30-weeks' gestation, limit use to the lowest effective dose for the shortest duration possible; ultrasound monitoring of amniotic fluid should be considered if NSAID use extends beyond 48 hours; if oligohydramnios occurs, discontinue NSAID and treat appropriately.

Animal studies have failed to reveal evidence of developmental abnormalities. Animal studies with other prostaglandin synthesis inhibitors revealed evidence of increased dystocia, delayed parturition, and decreased pup survival during labor and delivery. There are no controlled data in human pregnancy.

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

Salsalate Breastfeeding Warnings

Caution is recommended.
-According to some authorities: Use is not recommended.

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

Comments: The effects in the nursing infant are unknown.

Salicylic acid, the primary metabolite of this drug, has been shown to appear in human milk in concentrations approximating the maternal blood level. A nursing infant may ingest 30% to 80% as much salicylate per kilogram body weight as the mother is taking. The excretion of salicylate into breast milk increases disproportionately as the maternal dose increases. Reye's syndrome is associated with aspirin administration to infants with viral infections, but the risk of Reye's syndrome from salicylate in breast milk is unknown. An alternate drug is preferred over this drug during breastfeeding.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer