Prescription medicine
Clobazam Brand names: Sympazan, Onfi
Clobazam (Onfi) is a prescription medicine with an FDA approval on record since 2011. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.243 per clobazam 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
- DEA Schedule IV
Check it at the source: the clobazam FDA label on DailyMed (effective March 12, 2024, Lundbeck Pharmaceuticals LLC); the NDA 202067 record on Drugs@FDA; every clobazam label on DailyMed.
Highlights of the record
FDA label of March 12, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION.
and DEPENDENCE AND WITHDRAWAL REACTIONS 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 [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )]. The use of benzodiazepines, including ONFI, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing ONFI and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction [see Warnings and Precautions ( 5.2 )]. The continued use of benzodiazepines, including ONFI, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of ONFI after continued use may precipitate acute withdrawal reactions, which can be life-threatening. […]
Used for
From the label: indications and usageONFI ® (clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Forms and strengths
- 5 mg
- 10 mg
- 20 mg
- 2.5 mg/ml
Tablet; suspension; film.
On the market
- Earliest approval on file
- October 21, 2011 Onfi, Lundbeck Pharms Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 31 first October 22, 2018; 17 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 18 of which 16 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- January 31, 2040 Sympazan film; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.243 per tablet Clobazam 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 7 since 2019 0 Class I among all firms' recalls; latest January 7, 2025
- FAERS reports
- 24,270 through July 30, 2026
What is clobazam used for?
From the label: indications and usageONFI ® (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
FDA pharmacologic class: Benzodiazepine.
Source: FDA drug label (Onfi), Lundbeck Pharmaceuticals LLC, effective March 12, 2024 (SPL set de03bd69-2dca-459c-93b4-541fd3e9571c), via openFDA; the full label on DailyMed
What does the patient leaflet for clobazam 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 ONFI?ONFI is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death. Get emergency help right away if any of the following happens: shallow or slowed breathing breathing stops (which may lead to the heart stopping) excessive sleepiness (sedation) Do not drive or operate heavy machinery until you know how taking ONFI with opioids affects you. Risk of abuse, misuse, and addiction. There is a risk of abuse, misuse, and addiction with benzodiazepines, including ONFI, which can lead to overdose and serious side effects including coma and death. Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including ONFI. These serious side effects may also include delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these serious side effects. You can develop an addiction even if you take ONFI as prescribed by your healthcare provider. Take ONFI exactly as your healthcare provider prescribed. Do not share your ONFI with other people. Keep ONFI in a safe place and away from children. Physical dependence and withdrawal reactions. ONFI can cause physical dependence and withdrawal reactions. Do not suddenly stop taking ONFI . […]
From the patient leaflet: What should I avoid while taking ONFI?See “What is the most important information I should know about ONFI?”
From the patient leaflet: How should I store ONFI?Store ONFI tablets and oral suspension at room temperature between 68°F to 77°F (20°C to 25°C). Tablets Keep ONFI tablets in a dry place. Oral Suspension Replace the cap securely after opening. Store and dispense the oral suspension in its original bottle in an upright position. Use ONFI oral suspension within 90 days of first opening the bottle. After 90 days safely throw away any ONFI oral suspension that has not been used. Keep ONFI and all medicines out of the reach of children. General Information about the safe and effective use of ONFI. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ONFI for a condition for which it was not prescribed. Do not give ONFI to other people, even if they have the same symptoms that you have. It may harm them. […]
Source: FDA drug label (Onfi), Lundbeck Pharmaceuticals LLC, effective March 12, 2024 (SPL set de03bd69-2dca-459c-93b4-541fd3e9571c), via openFDA; the full label on DailyMed
Is there a generic for clobazam (Onfi)?
The FDA approved the first generic clobazam on October 22, 2018. 31 generic applications are approved; 17 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists clobazam from 16 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Onfi tablets; a patent listed only for Sympazan film runs to January 31, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 earliest approval on file
- 2018 first generic approved
- 2040 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for clobazam (Onfi)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.243 per Clobazam 10 mg tablet, down 3% from $0.250 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Clobazam 10 mg tablet (generic)
- Onfi 2.5 mg/mL suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clobazam 10 mg tablet | Generic | $0.243 per tablet | $7.28 | -3% |
| Clobazam 2.5 mg/mL suspension | Generic | $0.173 per mL | n/a | -10% |
| Clobazam 20 mg tablet | Generic | $0.432 per tablet | $12.96 | +4% |
| Onfi 10 mg tablet | Brand | $29.91 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $897.39 | -0.2% |
| Onfi 2.5 mg/mL suspension | Brand | $12.47 per mL | n/a | -0.1% |
| Onfi 20 mg tablet | Brand | $59.82 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $1,794.48 | -0.4% |
| Sympazan 10 mg film | Brand | $32.76 per film many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +2% |
| Sympazan 20 mg film | Brand | $65.43 per film many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +2% |
| Sympazan 5 mg film | Brand | $16.40 per film many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has clobazam been recalled?
The FDA's Enforcement Report lists 7 recalls naming clobazam since 2019: 0 Class I (the most serious), 7 Class II, 0 Class III; 3 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| January 7, 2025 | Class II | Amerisource Health Services LLC | Presence of Foreign Tablets/Capsules |
| December 13, 2024 | Class II | Amerisource Health Services LLC | Presence of Foreign Tablets/Capsules |
| February 12, 2024 | Class II | Micro Labs Limited | CGMP Deviations: Out of specification for residual solvents. |
| March 2, 2023 | Class II | Breckenridge Pharmaceutical, Inc | CGMP Deviations: Potential risk of Cross Contamination |
| January 7, 2022 | Class II | VistaPharm, Inc. | Failed Stability Specifications |
| July 16, 2019 | Class II | Bionpharma Inc. | Microbial Contamination of Non-Sterile Products: Out-of-specification results for Microbial Enumeration Tests USP <61> was observed. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the clobazam label say about other medicines?
The clobazam label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name clobazam. 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 |
|---|---|---|
| Cannabidiol | drug interactions | Dosage adjustment of SYMPAZAN ® may be necessary ( 7.4 ) Cannabidiol: May increase risk of SYMPAZAN-related adverse reactions; consider dosage adjustment if this occurs |
| Fluconazole | drug interactions | Dosage adjustment of ONFI may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole) [see Clinical Pharmacology ( 12.3 )]. |
| Flumazenil | warnings and precautions | Abrupt discontinuation or rapid dosage reduction of ONFI after continued use, or administration of flumazenil (a benzodiazepine antagonist) may precipitate acute withdrawal reactions, which can be life-threatening (e.g., seizures) [see Drug Abuse and Dependence ( 9.3 )]. |
| Fluvoxamine | drug interactions | Dosage adjustment of ONFI may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole) [see Clinical Pharmacology ( 12.3 )]. |
| Omeprazole | drug interactions | Dosage adjustment of ONFI may be necessary when co-administered with strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) or moderate CYP2C19 inhibitors (e.g., omeprazole) [see Clinical Pharmacology ( 12.3 )]. |
Other labels that name clobazam
Source: FDA drug label (Onfi), Lundbeck Pharmaceuticals LLC, effective March 12, 2024 (SPL set de03bd69-2dca-459c-93b4-541fd3e9571c), via openFDA; the full label on DailyMed
What do FAERS reports show for clobazam?
The FDA Adverse Event Reporting System holds 24,270 reports that list clobazam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,565 are coded as a death and 8,270 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?
- Other benzodiazepines
- the pharmacologic class, with prices and generics
- Clobazam side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other