Topiramate

SFDA Saudi Arabia — SFDA human drug list

US FDA United States — FDA approvals (Drugs@FDA)

35 more — full table

Canada Canada — marketed products (Health Canada)

17 more — full table

Prices — United States and England

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

• US FDA 6 Mar 2026 EPRONTIA — safety-related labeling change
  Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
• US FDA 6 Mar 2026 QSYMIA — safety-related labeling change
  Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
• US FDA 6 Mar 2026 QUDEXY XR — safety-related labeling change
  Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
• US FDA 6 Mar 2026 TOPAMAX — safety-related labeling change
  Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
• US FDA 6 Mar 2026 TOPAMAX — safety-related labeling change
  Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
• US FDA 6 Mar 2026 TOPAMAX SPRINKLE — safety-related labeling change
  Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
• US FDA 6 Mar 2026 TROKENDI XR — safety-related labeling change
  Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
• MHRA 20 Jun 2024 Topiramate (Topamax): introduction of new safety measures, including a Pregnancy Prevention Programme
  Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled. This follows a review by the MHRA which concluded that the use of topiramate during pregnancy is associated with significant harm to the unborn child. Harms included a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autistic spectrum disorder and attention deficit hyperactivity disorder in children of mothers taking topiramate during pregnancy.
• EMA PRAC 1 Sep 2022 PRAC signal: Neurodevelopmental disorders due to in utero exposure
  Action for MAH: update of the product information: No
• MHRA 21 Jul 2022 Topiramate (Topamax): start of safety review triggered by a study reporting an increased risk of neurodevelopmental disabilities in children with prenatal exposure
  We have initiated a new safety review into topiramate as a result of an observational study reporting an increased risk of neurodevelopmental disabilities in children whose mothers took topiramate during pregnancy. Topiramate is known to be associated with an increased risk of congenital malformations and effects on fetal growth if used during pregnancy. Continue to counsel patients who can become pregnant on the known and emerging risks of topiramate for an unborn baby and on the need to use effective contraception throughout use.
• EMA PRAC 7 Jul 2022 PRAC signal: Neurodevelopmental disorders due to in utero exposure
  Action for MAH: update of the product information: No
• EMA PRAC 14 Jun 2019 PRAC signal: Uveitis
  Action for MAH: update of the product information: Yes
• EMA PRAC 17 Jan 2019 PRAC signal: Uveitis
  Action for MAH: update of the product information: No

All safety entries for topiramate →

Combinations containing Topiramate

• Phentermine + topiramate