Clobazam is a benzodiazepine indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. It is available as tablets, oral suspension and oral films. MedsAcross supplies Clobazam for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
ONFI ® (clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. ONFI is a benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older
Source: US FDA prescribing information
The exact mechanism of action for clobazam, a 1,5-benzodiazepine, is not fully understood but is thought to involve potentiation of GABAergic neurotransmission resulting from binding at the benzodiazepine site of the GABA A receptor.
Source: US FDA prescribing information
For doses above 5 mg/day administer in two divided doses. Patients ≤30 kg body weight: Initiate at 5 mg daily and titrate as tolerated up to 20 mg daily. Patients >30 kg body weight: Initiate at 10 mg daily and titrate as tolerated up to 40 mg daily. Dosage adjustment needed in following groups: Geriatric patients. Known CYP2C19 poor metabolizers. Mild or moderate hepatic impairment, no information for severe hepatic impairment. Tablets: Administer whole, broken in half along the score, or crush and mix in applesauce. Measure prescribed amount of oral suspension using provided adapter and dosing syringe. Tablets and Oral suspension: Can be taken with or without food
Source: US FDA prescribing information
ONFI is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. Hypersensitivity reactions have included serious dermatological reactions. History of hypersensitivity to the drug or its ingredients
Source: US FDA prescribing information
Boxed warning: Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. Somnolence or Sedation: Monitor for central nervous system (CNS) depression. Risk may be increased with concomitant use of other CNS depressants. Serious Dermatological Reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis): Discontinue ONFI at first sign of rash unless the rash is clearly not drug-related. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: Discontinue if no alternative etiology.
Source: US FDA prescribing information
Clinically significant adverse reactions that appear in other sections of the labeling include the following: Risks from Concomitant Use with Opioids Abuse, Misuse, and Addiction Dependence and Withdrawal Reactions Potentiation of Sedation from Concomitant Use with Central Nervous System Depressants Somnolence or Sedation Serious Dermatological Reactions Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Suicidal Behavior and Ideation Neonatal Sedation and Withdrawal Syndrome Adverse reactions that occurred at least 10% more frequently than placebo in any ONFI dose included constipation, somnolence or sedation, pyrexia, lethargy, and drooling
Source: US FDA prescribing information
Alcohol: Increases blood levels of clobazam by about 50%. Drugs metabolized by CYP2D6: Lower doses of these drugs may be required when used concomitantly with ONFI. Strong or Moderate CYP2C19 Inhibitors: Dosage adjustment of ONFI may be necessary
Source: US FDA prescribing information
Store tablets and oral suspension at 20°C to 25°C (68°F to 77°F). See USP controlled room temperature. Store and dispense ONFI oral suspension in its original bottle in an upright position.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
10 presentations of Clobazam, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Clobazam 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Clobazam 20 mg tabletOralGeneric name | — | US FDA | Available on request |
| Clobazam 2.5 mg/mL oral suspensionOralGeneric name | — | US FDA | Available on request |
| Clobazam 5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Onfi 10 mg tabletOral | Lundbeck Pharmaceuticals | US FDA | Available on request |
| Onfi 2.5 mg/mL oral suspensionOral | Lundbeck Pharmaceuticals | US FDA | Available on request |
| Onfi 20 mg tabletOral | Lundbeck Pharmaceuticals | US FDA | Available on request |
| Sympazan 10 mg oral filmOral | Aquestive Therapeutics | US FDA | Available on request |
| Sympazan 20 mg oral filmOral | Aquestive Therapeutics | US FDA | Available on request |
| Sympazan 5 mg oral filmOral | Aquestive Therapeutics | US FDA | Available on request |
2 brand names across 1 markets.
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 21 October 2011 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Clobazam in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 10 presentations of Clobazam and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Clobazam, including Onfi, Sympazan.
Yes. The US FDA first approved Clobazam on 21 October 2011, according to Drugs@FDA.
No listed presentation of Clobazam is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Clobazam is classified under ATC code N05BA09 (Clobazam).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.