Prescription medicine
Stiripentol Brand names: Diacomit
Stiripentol (Diacomit) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the stiripentol FDA label on DailyMed (effective April 27, 2026, BIOCODEX, INC.); the NDA 207223 record on Drugs@FDA; every stiripentol label on DailyMed.
Highlights of the record
FDA label of April 27, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more.
Forms and strengths
- 250 mg
- 500 mg
Powder for suspension; capsule.
On the market
- Earliest approval on file
- August 20, 2018 Diacomit, Biocodex Sa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,141 through July 30, 2026
What is stiripentol used for?
From the label: indications and usageDIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome. DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome.
Source: FDA drug label (Diacomit), BIOCODEX, INC., effective April 27, 2026 (SPL set 58304ba8-9779-4658-811e-94ffe08c3f16), via openFDA; the full label on DailyMed
What does the patient leaflet for stiripentol say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about DIACOMIT?DIACOMIT can cause serious side effects, including: Sleepiness and drowsiness. Sleepiness and drowsiness are serious and common side effects. DIACOMIT can make you sleepy or dizzy, and slow your thinking. Your healthcare provider may decrease your dose of clobazam or other seizure medicines. Do not drive, operate heavy machinery, or do other dangerous activities until you know how DIACOMIT affects you. Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking DIACOMIT until you talk to your healthcare provider. DIACOMIT, when taken with alcohol or medicines that cause sleepiness or dizziness, may make your sleepiness or dizziness worse. Loss of appetite and weight loss. Loss of appetite and weight loss are serious and common side effects. DIACOMIT can cause frequent nausea and loss of appetite that can cause weight loss. Your weight should be checked frequently during DIACOMIT treatment. Children who take DIACOMIT should have their weight and growth checked often. Low white blood cell counts (neutropenia) and low platelet counts (thrombocytopenia). Low white blood cell counts may occur during treatment with DIACOMIT and may cause serious infections. Low platelet counts may cause serious bleeding problems. Your healthcare provider should check your white blood cell count and platelet count before and during treatment. Do not stop taking DIACOMIT without first talking to your healthcare provider. Stopping a seizure medicine such as DIACOMIT should be done slowly to avoid having seizures more often, or seizures that do not stop (status epilepticus). Like other antiepileptic drugs, DIACOMIT may cause suicidal thoughts or actions in a very small number of people (about 1 in 500). […]
From the patient leaflet: What should I avoid while taking DIACOMIT?Do not drive, operate heavy machinery, or do other dangerous activities that need you to be alert until you know how DIACOMIT affects you. Do not drink alcohol or take other medicines that may make you sleepy or dizzy while taking DIACOMIT without first talking to your healthcare provider.
From the patient leaflet: How should I store DIACOMIT?Store DIACOMIT at room temperature between 68°F to 77°F (20°C to 25°C). Store in a dry place in the original package. Protect from light. Keep DIACOMIT and all medicines out of the reach of children.
Source: FDA drug label (Diacomit), BIOCODEX, INC., effective April 27, 2026 (SPL set 58304ba8-9779-4658-811e-94ffe08c3f16), via openFDA; the full label on DailyMed
Is there a generic for stiripentol (Diacomit)?
No generic stiripentol is approved (Drugs@FDA, October 8, 2026).
- 2018 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the stiripentol label say about other medicines?
The stiripentol label names 17 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name stiripentol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Caffeine | drug interactions | Because of potential drug-drug interactions, consider dose adjustment of CYP1A2 substrates (e.g., theophylline, caffeine), CYP2B6 substrates (e.g., sertraline, thiotepa), and CYP3A4 substrates (e.g., midazolam, triazolam, quinidine), as clinically appropriate, when administered concomitantly with DIACOMIT. |
| Carbamazepine | drug interactions | Because of potential inhibition of enzyme/transporter activity, consider a reduction in dosage of substrates of CYP2C8, CYP2C19 (e.g., diazepam, clopidogrel), P-gp (e.g., carbamazepine), and BCRP (e.g., methotrexate, prazosin, glyburide), if adverse reactions are experienced when administered concomitantly with … |
| Clobazam | drug interactions | DRUG INTERACTIONS DIACOMIT increases the plasma concentration of clobazam and its metabolite through metabolic inhibition of CYP3A4 and CYP2C19. |
| Clopidogrel | drug interactions | Because of potential inhibition of enzyme/transporter activity, consider a reduction in dosage of substrates of CYP2C8, CYP2C19 (e.g., diazepam, clopidogrel), P-gp (e.g., carbamazepine), and BCRP (e.g., methotrexate, prazosin, glyburide), if adverse reactions are experienced when administered concomitantly with … |
| Diazepam | drug interactions | Because of potential inhibition of enzyme/transporter activity, consider a reduction in dosage of substrates of CYP2C8, CYP2C19 (e.g., diazepam, clopidogrel), P-gp (e.g., carbamazepine), and BCRP (e.g., methotrexate, prazosin, glyburide), if adverse reactions are experienced when administered concomitantly with … |
| Glyburide | drug interactions | Because of potential inhibition of enzyme/transporter activity, consider a reduction in dosage of substrates of CYP2C8, CYP2C19 (e.g., diazepam, clopidogrel), P-gp (e.g., carbamazepine), and BCRP (e.g., methotrexate, prazosin, glyburide), if adverse reactions are experienced when administered concomitantly with … |
| Methotrexate | drug interactions | Because of potential inhibition of enzyme/transporter activity, consider a reduction in dosage of substrates of CYP2C8, CYP2C19 (e.g., diazepam, clopidogrel), P-gp (e.g., carbamazepine), and BCRP (e.g., methotrexate, prazosin, glyburide), if adverse reactions are experienced when administered concomitantly with … |
| Midazolam | drug interactions | Because of potential drug-drug interactions, consider dose adjustment of CYP1A2 substrates (e.g., theophylline, caffeine), CYP2B6 substrates (e.g., sertraline, thiotepa), and CYP3A4 substrates (e.g., midazolam, triazolam, quinidine), as clinically appropriate, when administered concomitantly with DIACOMIT. |
| Phenobarbital | drug interactions | Drugs on DIACOMIT Induction-based interactions leading to decreases in DIACOMIT concentrations are possible when co-administered with a potent CYP1A2, CYP3A4, or CYP2C19 inducer, such as rifampin, phenytoin, phenobarbital and carbamazepine, as these enzymes all metabolize stiripentol. |
| Phenytoin | drug interactions | Drugs on DIACOMIT Induction-based interactions leading to decreases in DIACOMIT concentrations are possible when co-administered with a potent CYP1A2, CYP3A4, or CYP2C19 inducer, such as rifampin, phenytoin, phenobarbital and carbamazepine, as these enzymes all metabolize stiripentol. |
| Prazosin | drug interactions | Because of potential inhibition of enzyme/transporter activity, consider a reduction in dosage of substrates of CYP2C8, CYP2C19 (e.g., diazepam, clopidogrel), P-gp (e.g., carbamazepine), and BCRP (e.g., methotrexate, prazosin, glyburide), if adverse reactions are experienced when administered concomitantly with … |
| Quinidine | drug interactions | Because of potential drug-drug interactions, consider dose adjustment of CYP1A2 substrates (e.g., theophylline, caffeine), CYP2B6 substrates (e.g., sertraline, thiotepa), and CYP3A4 substrates (e.g., midazolam, triazolam, quinidine), as clinically appropriate, when administered concomitantly with DIACOMIT. |
| Rifampin | drug interactions | Drugs on DIACOMIT Induction-based interactions leading to decreases in DIACOMIT concentrations are possible when co-administered with a potent CYP1A2, CYP3A4, or CYP2C19 inducer, such as rifampin, phenytoin, phenobarbital and carbamazepine, as these enzymes all metabolize stiripentol. |
| Sertraline | drug interactions | Because of potential drug-drug interactions, consider dose adjustment of CYP1A2 substrates (e.g., theophylline, caffeine), CYP2B6 substrates (e.g., sertraline, thiotepa), and CYP3A4 substrates (e.g., midazolam, triazolam, quinidine), as clinically appropriate, when administered concomitantly with DIACOMIT. |
Every other medicine the stiripentol label names
| Medicine named | Section | What the label says |
|---|---|---|
| Theophylline | drug interactions | Because of potential drug-drug interactions, consider dose adjustment of CYP1A2 substrates (e.g., theophylline, caffeine), CYP2B6 substrates (e.g., sertraline, thiotepa), and CYP3A4 substrates (e.g. … |
| Thiotepa | drug interactions | … (e.g., theophylline, caffeine), CYP2B6 substrates (e.g., sertraline, thiotepa), and CYP3A4 substrates (e.g., midazolam, triazolam, quinidine), as clinically appropriate, when administered … |
| Triazolam | drug interactions | … (e.g., sertraline, thiotepa), and CYP3A4 substrates (e.g., midazolam, triazolam, quinidine), as clinically appropriate, when administered concomitantly with DIACOMIT. |
Other labels that name stiripentol
Source: FDA drug label (Diacomit), BIOCODEX, INC., effective April 27, 2026 (SPL set 58304ba8-9779-4658-811e-94ffe08c3f16), via openFDA; the full label on DailyMed
What do FAERS reports show for stiripentol?
The FDA Adverse Event Reporting System holds 2,141 reports that list stiripentol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 108 are coded as a death and 723 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Stiripentol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other