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Riluzole use while Breastfeeding

Medically reviewed by Last updated on Apr 11, 2023.

Drugs containing Riluzole: Rilutek, Exservan, Tiglutik

Riluzole Levels and Effects while Breastfeeding

Summary of Use during Lactation

Limited information indicates that maternal doses of riluzole up to 100 mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Until more data are available, use riluzole with caution, particularly when breastfeeding a newborn.

Drug Levels

Maternal Levels. A woman who was breastfeeding her 18-month-old infant 3 to 4 times a day was diagnosed with amyotrophic lateral sclerosis and started on riluzole 50 mg twice daily by mouth. On the third day of therapy, milk samples were collected before and at 1, 2, 4, 8, and 12 hours after the first dose of the day. The pre-dose sample contained 33.8 mcg/L of riluzole. The peak concentration in milk was 229.5 mcg/L at 2 hours after the dose. The average milk concentration was 94.4 mcg/L over the 12-hour collection time, which would provide the infant with an estimated daily dosage 14.1 mcg/kg. Based on the 12-hour collection period, the maternal weight-adjusted dosage was 0.8%. Riluzole metabolites were not measured.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.


Datta P, Rewers-Felkins K, Aurora N, et al. Estimation of riluzole levels in human milk and infant exposure during its use in a patient with ALS. J Hum Lact. 2018;34:355–7. [PubMed: 29100479]

Substance Identification

Substance Name


CAS Registry Number


Drug Class

Breast Feeding


Excitatory Amino Acid Antagonists

Neuroprotective Agents

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Further information

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