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Clobazam

Clobazam is a benzodiazepine seizure medicine used along with other medicines to treat seizures linked to Lennox-Gastaut syndrome in people 2 years and older.

Brand names OnfiSympazan
Drug class Benzodiazepine
Rx Schedule CIV Forms 3
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 23 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026 🚨Recall on record · 3
Clobazam at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Clobazam (Onfi, Sympazan) is a benzodiazepine that boosts GABA, the brain's calming messenger, and is a well-established add-on medicine for seizures from Lennox-Gastaut syndrome, a severe form of epilepsy, in people 2 and older; it has been on the U.S. market since about 2010 and is available as a generic. Most people tolerate it reasonably well, though sleepiness and low energy are common, sometimes with drooling or irritability. Its boxed warning covers dangerous sedation and slowed breathing with opioids, plus abuse, addiction and dependence, so never stop it suddenly, because withdrawal can trigger seizures. Call the prescriber at the first sign of a rash, since serious skin reactions can occur, mostly early on.

Clinical pearls

  • Hormonal birth control may work less well on clobazam, so add a non-hormonal method such as condoms.
  • Skip alcohol, which deepens the drowsiness and also pushes clobazam levels higher in the blood.
  • Tell every prescriber you take clobazam; fluconazole, fluvoxamine and omeprazole can raise its active form enough to need a dose change.
  • If cannabidiol is added to the seizure plan, watch for extra sleepiness, since it can intensify clobazam side effects.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Taking clobazam with opioids can cause extreme sleepiness, slowed breathing, coma, and death. It should be combined with opioids only when other options are not enough, at the lowest dose and shortest time.

Benzodiazepines like clobazam can lead to abuse, misuse, and addiction, which can cause overdose or death. The risk is higher when mixed with alcohol, other medicines, or illicit substances.

With continued use, your body can become physically dependent. Stopping suddenly or cutting the dose too fast can cause life-threatening withdrawal, including seizures. Risk rises with higher doses and longer use. Your prescriber should lower the dose gradually.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Oral suspension, Dissolving oral film
Earliest FDA record2010
Companies listing it with the FDA18
FDA label last updatedMar 12, 2024
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Clobazam, written from its FDA label.

What Clobazam is used for

▾

Clobazam is used for one approved condition across its products.

  • Add-on treatment of seizures from Lennox-Gastaut syndrome (LGS) in people 2 years and older.
  • This applies to Sympazan (oral film), Onfi (tablets and oral suspension), and clobazam tablets and oral suspension.

How Clobazam works

▾

Clobazam is a benzodiazepine. It is thought to work by binding to the benzodiazepine site on the GABA-A receptor in the brain. This boosts GABA, a calming chemical messenger, which helps quiet overactive brain signals. The exact mechanism is not fully understood.

Clobazam dosage

▾

Clobazam is taken by mouth as a tablet, oral suspension, or dissolving film (Sympazan). Dosing depends on body weight and is increased slowly, no faster than weekly. Amounts above the lowest daily dose are split into two doses a day.

  • It can be taken with or without food.
  • Tablets can be swallowed whole, split along the score, or crushed in applesauce.
  • Sympazan is placed on the tongue and not taken with liquids.
  • Suspension is measured with the provided syringe.
  • Do not stop suddenly. Your prescriber will taper the dose slowly.

Follow your prescriber and the product label.

Dosing details from the FDA-approved label

From the Clobazam prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Patients ≤30 kg body weight (30 kg or less)
    • Initiate at 5 mg daily
    • Starting day 7: 10 mg
    • Starting day 14: 20 mg
    • Titrate as tolerated
    • Do not escalate more rapidly than weekly
    • Doses above 5 mg/day are given in two divided doses
    • A 5 mg daily dose can be given as a single dose
    • Maximum: 20 mg daily
    • Individualize dosing within each weight group based on clinical efficacy and tolerability
  • Patients >30 kg body weight
    • Initiate at 10 mg daily
    • Starting day 7: 20 mg
    • Starting day 14: 40 mg
    • Titrate as tolerated
    • Do not escalate more rapidly than weekly
    • Doses above 5 mg/day are given in two divided doses
    • Maximum: 40 mg daily
    • Individualize dosing within each weight group based on clinical efficacy and tolerability
  • Geriatric patients
    • Starting dose 5 mg/day for all elderly patients
    • Titrate according to weight, but to half the dose presented in Table 1, as tolerated
    • If necessary, an additional titration to the maximum dose may be started on day 21
    • Maximum: 20 mg/day or 40 mg/day, depending on weight
    • Plasma concentrations are generally higher in the elderly; proceed slowly with dose escalation
  • Known CYP2C19 poor metabolizers
    • Starting dose 5 mg/day
    • Titrate slowly according to weight, but to half the dose presented in Table 1, as tolerated
    • If necessary, an additional titration to the maximum dose may be started on day 21
    • Maximum: 20 mg/day or 40 mg/day, depending on weight group
    • Levels of N-desmethylclobazam, the active metabolite, will be increased
  • Mild to moderate hepatic impairment (Child-Pugh score 5-9)
    • Starting dose 5 mg/day in both weight groups
    • Titrate according to weight, but to half the dose presented in Table 1, as tolerated
    • If necessary, start an additional titration on day 21
    • Maximum: 20 mg/day or 40 mg/day, depending on weight group
    • Proceed slowly with dose escalations; no dosing recommendation can be given for severe hepatic impairment
  • Mild and moderate renal impairment
    • No dose adjustment is required
    • No experience in severe renal impairment or ESRD
  • Discontinuation or dosage reduction
    • Use a gradual taper: decrease the total daily dose by 5-10 mg/day on a weekly basis until discontinued
    • If withdrawal reactions develop, consider pausing the taper or increasing to the previous tapered dosage level, then decrease more slowly
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION For doses above 5 mg/day administer in two divided doses ( 2.1 ) Patients ≤30 kg body weight: Initiate at 5 mg daily and titrate as tolerated up to 20 mg daily ( 2.1 ) Patients >30 kg body weight: Initiate at 10 mg daily and titrate as tolerated up to 40 mg daily ( 2.1 ) Dosage adjustment needed in following groups: Geriatric patients ( 2.4 , 8.5 ) Known CYP2C19 poor metabolizers ( 2.5 ) Mild or moderate hepatic impairment; no information for severe hepatic impairment ( 2.7 , 8.8 ) Tablets: Administer whole, broken in half along the score, or crush and mix in applesauce ( 2.3 ) Measure prescribed amount of oral suspension using provided adapter and dosing syringe ( 2.3 ) Tablets and Oral suspension: Can be taken with or without food ( 2.3 ) 2.1 Dosing Information A daily dose of ONFI greater than 5 mg should be administered in divided doses twice daily; a 5 mg daily dose can be administered as a single dose. Dose patients according to body weight. Individualize dosing within each body weight group, based on clinical efficacy and tolerability. Each dose in Table 1 (e.g., 5 to 20 mg in ≤30 kg weight group) has been shown to be effective, although effectiveness increases with increasing dose [see Clinical Studies ( 14 )] . Do not proceed with dose escalation more rapidly than weekly, because serum concentrations of clobazam and its active metabolite require 5 and 9 days, respectively, to reach steady-state. Table 1. Recommended Total Daily Dosing by Weight Group ≤30 kg Body Weight >30 kg Body Weight Starting Dose 5 mg 10 mg Starting Day 7 10 mg 20 mg Starting Day 14 20 mg 40 mg 2.2 Discontinuation or Dosage Reduction of ONFI To reduce the risk of withdrawal reactions, increased seizure frequency, and status epilepticus, use a gradual taper to discontinue ONFI or reduce the dosage. Taper by decreasing the total daily dose by 5-10 mg/day on a weekly basis until discontinued. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly [see Warnings and Precautions ( 5.3 ) and Drug Abuse and Dependence ( 9.3 )] . 2.3 Important Administration Instructions Instruct patients to read the "Instructions for Use" carefully for complete directions on how to properly dose and administer ONFI oral suspension.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Clobazam side effects

▾

Common side effects seen in studies include:

Common side effects

  • Sleepiness or sedation
  • Lethargy (low energy)
  • Fever
  • Constipation
  • Drooling
  • Irritability or aggression
  • Vomiting
  • Trouble with balance or coordination (ataxia)
  • Poor balance or coordination

When to get medical help

  • Get help right away for slow or troubled breathing, extreme drowsiness, or being unable to wake up, especially if you also take opioids or alcohol.
  • Call your doctor right away at the first sign of a rash. Serious skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported.
  • Seek care for fever, rash, swollen glands, or facial swelling, which can signal a serious allergic reaction (DRESS).
  • Tell your doctor about new or worsening depression, unusual mood or behavior changes, or thoughts of self-harm.
  • Call your doctor if you have withdrawal symptoms or more seizures after lowering or missing doses.
  • Seek help if you feel you are misusing the medicine or craving it.

Clobazam warnings and precautions

▾
  • Opioids: combined use can cause profound sedation, slowed breathing, coma, and death.
  • Abuse, misuse, and addiction: can lead to overdose or death.
  • Dependence and withdrawal: stopping suddenly can cause life-threatening reactions, including seizures. Withdrawal symptoms can last weeks to over a year in some people.
  • Sleepiness: use caution driving or with machinery.
  • Serious skin reactions and DRESS: stop and call your doctor at the first sign of a rash.
  • Suicidal thoughts: seizure medicines can raise this risk, so watch for mood changes.
  • Newborns: use late in pregnancy can cause sedation or withdrawal in the baby.

Clobazam interactions

▾

Several medicines and substances can change how clobazam works or add to its effects.

  • Opioids: higher risk of dangerous slowed breathing.
  • Alcohol: more drowsiness and about 50% higher clobazam levels.
  • Other CNS depressants: added sleepiness.
  • CYP2C19 inhibitors (fluconazole, fluvoxamine, ticlopidine, omeprazole): may raise active metabolite levels.
  • Cannabidiol: may increase side effects.
  • Hormonal contraceptives: may be less effective.
  • CYP2D6 drugs: may need lower doses.

Interactions listed in the FDA-approved label

From the Clobazam prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Opioids: Concomitant use of benzodiazepines and opioids increases the risk of respiratory depression. Limit dosage and duration of concomitant use, and follow patients closely for respiratory depression and sedation.
  • Other CNS depressants: Concomitant use may increase the risk of sedation and somnolence. Caution patients or caregivers against simultaneous use with other CNS depressant drugs, as their effects may be potentiated.
  • Alcohol: Alcohol, as a CNS depressant, interacts in a similar way and increases clobazam's maximum plasma exposure by approximately 50%. Caution patients or caregivers against simultaneous use with alcohol, as its effects may be potentiated.
  • Hormonal contraceptives: Clobazam is a weak CYP3A4 inducer, so the effectiveness of some hormonal contraceptives may be diminished. Additional non-hormonal forms of contraception are recommended.
  • Drugs metabolized by CYP2D6: Clobazam inhibits CYP2D6. Dose adjustment of drugs metabolized by CYP2D6 may be necessary.
  • Strong CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine, ticlopidine) and moderate CYP2C19 inhibitors (e.g., omeprazole): May result in increased exposure to N-desmethylclobazam, the active metabolite, which may increase the risk of dose-related adverse reactions. Dosage adjustment of clobazam may be necessary.
  • Cannabidiol: Coadministration may increase the risk of clobazam-related adverse reactions. Consider a reduction in dosage of cannabidiol or clobazam if adverse reactions known to occur with clobazam are experienced.
Read the label’s full interactions text

7 DRUG INTERACTIONS Alcohol: Increases blood levels of clobazam by about 50% ( 7.2 ) Drugs metabolized by CYP2D6: Lower doses of these drugs may be required when used concomitantly with SYMPAZAN ® ( 7.3 ) Strong or Moderate CYP2C19 Inhibitors: Dosage adjustment of SYMPAZAN ® may be necessary ( 7.4 ) Cannabidiol: May increase risk of SYMPAZAN-related adverse reactions; consider dosage adjustment if this occurs ( 7.4 ) 7.1 Opioids The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at GABA A sites, and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists. Limit dosage and duration of concomitant use of benzodiazepines and opioids, and follow patients closely for respiratory depression and sedation [see Warnings and Precautions (5.1) ]. 7.2 CNS Depressants and Alcohol Concomitant use of SYMPAZAN ® with other CNS depressants may increase the risk of sedation and somnolence [see Warnings and Precautions (5.4) ]. Alcohol, as a CNS depressant, will interact with SYMPAZAN ® in a similar way and also increases clobazam's maximum plasma exposure by approximately 50%. Therefore, caution patients or their caregivers against simultaneous use with other CNS depressant drugs or alcohol, and caution that the effects of other CNS depressant drugs or alcohol may be potentiated [see Warnings and Precautions (5.4) ]. 7.3 Effect of SYMPAZAN ® on Other Drugs Hormonal Contraceptives SYMPAZAN ® is a weak CYP3A4 inducer. As some hormonal contraceptives are metabolized by CYP3A4, their effectiveness may be diminished when given with SYMPAZAN ® . Additional non-hormonal forms of contraception are recommended when using SYMPAZAN ® [see Clinical Pharmacology (12.3) , Patient Counseling Information (17) ].

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿109 supplements and herbs with documented Clobazam interactions, ranked by severity Check Clobazam against a supplement or herb →

Before taking Clobazam

▾
  • Do not use if you have had a hypersensitivity reaction to clobazam or its ingredients.
  • Pregnancy: may harm a fetus based on animal data. Use only if the benefit justifies the risk.
  • Breastfeeding: passes into milk. Watch infants for sleepiness and poor sucking.
  • Children: not established under 2 years.
  • Older adults: slower clearance, so dose adjustment is needed.
  • Liver impairment (mild or moderate): dose adjustment needed.
  • Known CYP2C19 poor metabolizers: dose adjustment needed.

Clobazam overdose

▾

Too much clobazam can cause drowsiness, confusion, poor coordination, and weak muscles. Severe cases can lead to slowed breathing and coma, and mixing with alcohol or opioids can be fatal. Seek emergency help or call Poison Help at 1-800-222-1222.

What Clobazam does in the body

▾

Clobazam acts on the brain as a central nervous system depressant, causing sleepiness and sedation. In a study of healthy volunteers at twice the maximum recommended dose, it did not lengthen the QTc interval (a heart rhythm measure) in any clinically meaningful way.

How your body processes Clobazam

▾

Clobazam is absorbed quickly and well after swallowing. Food does not change absorption of the tablets. The liver breaks it down into an active metabolite, N-desmethylclobazam, which is weaker and builds up to higher levels than clobazam itself. Half-lives are about 36 to 42 hours for clobazam and 71 to 82 hours for the metabolite. Most is cleared through urine. Older adults clear it more slowly, and people who are CYP2C19 poor metabolizers have higher metabolite levels.

How to store Clobazam

▾

Store and dispense clobazam oral suspension in its original bottle in an upright position. Store oral suspension at 20° to 25°C (68° to 77°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

109

Supplements & herbs that interact with Clobazam

109 supplements and herbal products have documented interactions with Clobazam in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 8
  • Moderate · 85
  • Minor · 16
1,4-BUTANEDIOL Major ACTIVATED CHARCOAL Major BEER Major GAMMA-HYDROXYBUTYRATE (GHB) Major GRAPEFRUIT Major KAVA Major L-TRYPTOPHAN Major WINE Major +101 more
Every supplement checked against Clobazam — ranked by severity The full interaction hub: 8 major · 85 moderate · 16 minor · every one linked to its full report. Check Clobazam against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Clobazam has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

VITAMIN K Insignificant Depletion
See the full Clobazam nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Clobazam: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Clobazam — the kind of thing our pharmacy team would talk through with you at the counter.

What is clobazam for?

▾
Clobazam is an add-on medicine for seizures caused by Lennox-Gastaut syndrome in people 2 years and older. It is used along with other seizure medicines, not on its own.

How should I take it?

▾
Take it by mouth exactly as prescribed, usually split into two doses a day if your dose is above the lowest amount. You can take it with or without food. Tablets can be swallowed whole, split, or crushed in applesauce. Sympazan film goes on your tongue, and the suspension is measured with the provided syringe.

Can I stop it if I feel fine?

▾
No. Stopping suddenly can cause withdrawal reactions, including seizures, and can be life-threatening. Your prescriber will lower the dose slowly over time.

What side effects should I expect?

▾
Sleepiness is the most common. You may also notice tiredness, fever, constipation, drooling, irritability, or poor balance. Call your doctor right away for a rash, breathing trouble, or mood changes.

Can I have a drink or take other medicines with it?

▾
Avoid alcohol, since it adds to drowsiness and raises clobazam levels. Opioids are especially risky because of slowed breathing. Tell me about every medicine you take, including birth control, since clobazam may make hormonal contraceptives less effective.

What if I am pregnant or breastfeeding?

▾
Talk to your doctor first. Clobazam may harm a developing baby, and newborns can have sedation or withdrawal. It also passes into breast milk, so a nursing baby should be watched for sleepiness and poor feeding.

Is Clobazam available over the counter?

▾
No. Clobazam is a prescription medicine: every Clobazam product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Clobazam a controlled substance?

▾
Yes — Clobazam is a federally controlled substance (Schedule IV) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Clobazam first available?

▾
The earliest FDA record we hold for Clobazam is from 2010: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Clobazam was first used.

Who makes Clobazam?

▾
18 companies currently list Clobazam products in the FDA's NDC Directory, including Ascend Laboratories, LLC, Amneal Pharmaceuticals NY LLC, Aquestive Therapeutics. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Clobazam on HelloPharmacist

📊Clobazam supplement interactions109 checked — ranked by severity 🌿Drug & Supplement CheckerClobazam vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Clobazam NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Clobazam Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Clobazam forms and strengths (how it comes)

Clobazam is available in 3 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Onfi
How this form is used
What it may be used for
  • Onfi tablets and clobazam tablets are used as add-on treatment of seizures from Lennox-Gastaut syndrome in people 2 years and older.
Important instructions
  • Onfi tablets and clobazam tablets can be swallowed whole, broken in half along the score, or crushed and mixed in applesauce.
  • Onfi tablets and clobazam tablets can be taken with or without food.
Available strengths 3 strengths
5 mg 10 mg 20 mg
63 FDA-listed product records ⓘ

Oral suspension

By mouth
Brands Onfi
How this form is used
What it may be used for
  • Onfi and clobazam oral suspension are used as add-on treatment of seizures from Lennox-Gastaut syndrome in people 2 years and older.
Important instructions
  • Onfi and clobazam oral suspension are measured with the provided adapter and dosing syringe.
  • Onfi and clobazam oral suspension can be taken with or without food.
  • Read the Instructions for Use that come with Onfi or clobazam oral suspension.
Available strengths 1 strength
2.5 mg/mL
30 FDA-listed product records ⓘ

Dissolving oral film

By mouth
Brands Sympazan
How this form is used
What it may be used for
  • Sympazan is used as add-on treatment of seizures from Lennox-Gastaut syndrome in people 2 years and older.
Important instructions
  • Sympazan is placed on top of the tongue, where it sticks and dissolves.
  • Sympazan can be taken with or without food.
  • Sympazan should not be taken with liquids.
  • Sympazan comes with Instructions for Use that patients or caregivers should read.
Available strengths 3 strengths
5 mg 10 mg 20 mg
9 FDA-listed product records ⓘ

Clobazam on the U.S. market: products, makers and brands

How Clobazam appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

18 companies list 36 Clobazam product records with the FDA, mostly as tablet, oral suspension, dissolving oral film; the earliest marketing or approval year on record is 2010. Brand names on the directory include Onfi, Sympazan; the rest are generics.

3
Dose forms ⓘ
18
Labelers (makers, repackagers, distributors)
3
Brand names
36
FDA-listed product records ⓘ
2010
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (10) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Ascend Laboratories, LLC11%
Amneal Pharmaceuticals NY LLC8%
Aquestive Therapeutics8%
Camber Pharmaceuticals, Inc.8%
Lundbeck Pharmaceuticals LLC8%
NorthStar RxLLC8%
Other makers47%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Clobazam is used (Medicaid data)

A general measure of how commonly Clobazam is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Clobazam is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

496,684
Medicaid prescriptions filled (Q1–Q4 2025)
$95.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Clobazam prescribed? Of the 1,601 medications we measure, Clobazam ranks #261 by Medicaid prescriptions — more than 84% of them.

Where Clobazam ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #261 of 1,601
#256 Methotrexate 533,549 Rx #257 Labetalol 525,457 Rx #258 Propofol 520,319 Rx #259 Pioglitazone 511,848 Rx #260 Dextromethorphan / Gua... 511,044 Rx #261 Clobazam 496,684 Rx #262 Prednisolone Ophthalmi... 496,500 Rx #263 Mometasone Topical 494,371 Rx #264 Rimegepant 492,967 Rx #265 Phenazopyridine 491,698 Rx #266 Ofloxacin Ophthalmic 488,232 Rx

Utilization by Clobazam product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg oral tablet is the most-dispensed Clobazam product — about 45% of these Medicaid prescriptions.

clobazam 10 MG Oral Tablet Most dispensed

221,688 Medicaid prescriptions (Q1–Q4 2025) 45% of Clobazam prescriptions shown $27.6M gross reimbursement (before rebates) ≈ $124 per prescription (gross)

Summed across the 8 of 33 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199450

clobazam 2.5 MG/ML Oral Suspension

189,506 Medicaid prescriptions (Q1–Q4 2025) 38% of Clobazam prescriptions shown $38.5M gross reimbursement (before rebates) ≈ $203 per prescription (gross)

Summed across the 7 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1366192

clobazam 20 MG Oral Tablet

79,817 Medicaid prescriptions (Q1–Q4 2025) 16% of Clobazam prescriptions shown $18.3M gross reimbursement (before rebates) ≈ $230 per prescription (gross)

Summed across the 7 of 30 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 246172

clobazam 10 MG Oral Film

2,322 Medicaid prescriptions (Q1–Q4 2025) <1% of Clobazam prescriptions shown $4.5M gross reimbursement (before rebates) ≈ $1,921 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2058253

clobazam 5 MG Oral Film

2,204 Medicaid prescriptions (Q1–Q4 2025) <1% of Clobazam prescriptions shown $2.4M gross reimbursement (before rebates) ≈ $1,109 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2058255

clobazam 20 MG Oral Film

1,147 Medicaid prescriptions (Q1–Q4 2025) <1% of Clobazam prescriptions shown $3.9M gross reimbursement (before rebates) ≈ $3,412 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2058254

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Clobazam, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 25 of 87 listed Clobazam NDCs with Medicaid activity.

Compare Clobazam products

A representative set of FDA-listed product records for Clobazam — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 36 of 36 products — FDA National Drug Code Directory. See every product, package size and price: browse all 36 Clobazam NDCs →

Clobazam recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 3 Clobazam recalls since July 2021. All of them are still ongoing or began in the last six months. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Jan 7, 2025 · Amerisource Health Services LLC
Presence of Foreign Tablets/Capsules
  • Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-4… Lots: Lot #: 1018598, Exp. Date 10/31/2025 FDA record D-0201-2025 →
Ongoing Class II Dec 13, 2024 · Amerisource Health Services LLC
Presence of Foreign Tablets/Capsules
  • Clobazam Tablets, 10 mg, packaged in 30 tablets per carton (3x10 blister cards each), Rx Only, Amneal Pharmaceuticals LLC, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-4… Lots: Lot #: 1019594, Exp. Date 12/31/2025 FDA record D-0184-2025 →
Ongoing Class II Feb 12, 2024 · Micro Labs Limited
CGMP Deviations: Out of specification for residual solvents.
  • Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01 Lots: ZOAG043 FDA record D-0348-2024 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Clobazam RxCUI 21241 3 dose forms · 7 strengths
  1. Dose form (SCDF) Oral Film RxCUI 2269618 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 2058255 10 MG RxCUI 2058253 20 MG RxCUI 2058254
  2. Dose form (SCDF) Oral Suspension RxCUI 1366191 In current FDA listings
    Clinical drug / strength (SCD) 2.5 MG/ML RxCUI 1366192
  3. Dose form (SCDF) Oral Tablet RxCUI 371560 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 427538 10 MG RxCUI 199450 20 MG RxCUI 246172

Look up RxCUI 21241 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Clobazam costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet · Oral 10 mg $0.243 per tablet NDC details & price history
Tablet · Oral 20 mg $0.432 per tablet NDC details & price history
Suspension · Oral 2.5 mg/mL $0.173 per mL NDC details & price history
Film · Oral 5 mg $16.40 each NDC details & price history
Film · Oral 10 mg $32.76 each NDC details & price history
Film · Oral 20 mg $65.43 each NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Clobazam brand names

Clobazam is sold under 2 brand names in the FDA directory — Onfi, Sympazan. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Onfi Sympazan

Who makes Clobazam: manufacturers and labelers

18 companies list Clobazam products with the FDA. By number of product records, the largest are Ascend Laboratories, LLC, Amneal Pharmaceuticals NY LLC, Aquestive Therapeutics. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Ascend Laboratories, LLC 4 Amneal Pharmaceuticals NY LLC 3 Aquestive Therapeutics 3 Camber Pharmaceuticals, Inc. 3 Lundbeck Pharmaceuticals LLC 3 NorthStar RxLLC 3 Golden State Medical Supply, Inc. 2 Lupin Pharmaceuticals, Inc. 2 Micro Labs Limited 2 Novadoz Pharmaceuticals LLC 2 Upsher-Smith Laboratories, LLC 2 American Health Packaging 1 Aurobindo Pharma Limited 1 Bionpharma Inc. 1 Bryant Ranch Prepack 1 Chartwell RX, LLC 1 Precision Dose, Inc. 1 Taro Pharmaceuticals U.S.A., Inc. 1

Clobazam drug class (RxNorm)

Clobazam belongs to the Benzodiazepine class.

Pharmacologic class Benzodiazepine
Drug family (ATC) Benzodiazepine derivatives
How it works Cytochrome P450 2D6 Inhibitors, Cytochrome P450 3A4 Inducers

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Clobazam page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Mar 12, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Clobazam.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Clobazam after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
23
Finished products in the current FDA directory
36
Companies listing them (makers, repackagers, distributors)
18
FDA labeler codes behind them ⓘ
18
Linked representative label ⓘ
Lundbeck Pharmaceuticals LLC
Linked label effective
Mar 12, 2024
Composite sections available
27
Linked SPL Set ID
de03bd69-2dca-459c-93b4-541fd3e9571c
Linked SPL Document ID
68dbe31c-2dbe-49ad-8b2e-2cf1b8521167
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Lundbeck Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →