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clobazam

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Brand names: Onfi, Sympazan

Benzodiazepine (Anticonvulsant) Rx

Clobazam oral suspension is a medicine used with other medicines to treat seizures caused by Lennox-Gastaut syndrome. It is a type of drug called a benzodiazepine.

Drug Pricing (NADAC)

Brand Price

$28.58/unit

Generic Price

$0.24/unit

Generic Savings

99%

Generic Available

Yes (15 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Clobazam oral suspension is used to treat seizures in people 2 years and older who have Lennox-Gastaut syndrome (LGS).

Common side effects

Constipation, Sleepiness or drowsiness, Fever

Key warnings

Clobazam can cause serious side effects: * **Risk of Using with Opioids:** Taking clobazam with opioid medicines can cause severe sleepiness, slowed breathing, coma, and death.

How It Works

Clobazam belongs to a class of drugs called benzodiazepines. It works by affecting certain chemicals in the brain that may be unbalanced in people with seizures. This helps to reduce the frequency of seizures.

How to Take It

Take clobazam oral suspension as your doctor tells you. If your daily dose is more than 5 mg, take it in two divided doses. You can take it with or without food. Use the provided syringe to measure your dose. Shake the bottle well before each use.

Pregnancy & Breastfeeding

Clobazam may harm your unborn baby. If you are pregnant or plan to become pregnant, talk to your doctor. There is a pregnancy registry for women who take anti-epilepsy drugs like clobazam. You can enroll by calling 1-888-233-2334.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.

Storage

Store clobazam oral suspension in its original bottle in an upright position at room temperature (68°F to 77°F).

Side Effects (from patient reports)

Based on 16,662 FDA adverse event reports.

Seizure
4,619
Medicine not working
3,007
Using medicine for unapproved condition
2,034
Sleepiness
1,798
Medicine interaction
1,123
Tiredness
1,090
Epilepsy
805
Condition worsened
794
Prolonged seizure
698
Using product for unapproved condition
694

FDA Adverse Event Report Analysis

Detailed analysis of 23,107 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.

Total Reports

23,107

Death-Related Reports

1,511

Hospitalization Reports

7,829

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 9,125 (51%)
Male 8,533 (48%)

Age Distribution

0–17 5,637
18–44 4,606
45–64 1,861
65–74 567
75+ 360

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 SEIZURE 4,619
2 DRUG INEFFECTIVE 3,007
3 OFF LABEL USE 2,034
4 SOMNOLENCE 1,798
5 DRUG INTERACTION 1,123
6 FATIGUE 1,090
7 EPILEPSY 805
8 CONDITION AGGRAVATED 794
9 STATUS EPILEPTICUS 698
10 PRODUCT USE IN UNAPPROVED INDICATION 694
11 PNEUMONIA 663
12 FALL 630
13 AGGRESSION 622
14 DECREASED APPETITE 607
15 DIARRHOEA 598

Reactions in Death Reports

DEATH 439
TOXICITY TO VARIOUS AGENTS 147
OFF LABEL USE 137
DRUG INEFFECTIVE 115
CARDIAC ARREST 107
SEIZURE 98
RESPIRATORY FAILURE 87
PNEUMONIA 83
STATUS EPILEPTICUS 79
COMPLETED SUICIDE 75

Reactions in Hospitalization Reports

SEIZURE 1,647
DRUG INEFFECTIVE 965
OFF LABEL USE 864
SOMNOLENCE 600
PNEUMONIA 517
DRUG INTERACTION 495
STATUS EPILEPTICUS 398
HOSPITALISATION 352
PYREXIA 349
EPILEPSY 337

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Clobazam can cause serious side effects: * **Risk of Using with Opioids:** Taking clobazam with opioid medicines can cause severe sleepiness, slowed breathing, coma, and death. Only take them together if no other treatment works, and use the lowest dose for the shortest time. * **Risk of Abuse, Misuse, and Addiction:** Clobazam can be abused, misused, and lead to addiction, overdose or death. Your doctor will assess your risk before and during treatment. * **Risk of Dependence and Withdrawal:** Taking clobazam can lead to physical dependence. Stopping it suddenly can cause life-threatening withdrawal symptoms. To stop, your doctor will slowly lower your dose.

Known Drug Interactions

moderate cannabidiol

7.2 Effect of EPIDIOLEX on Other Drugs Antiepileptic Drugs Clobazam Concomitant use of EPIDIOLEX with clobazam increases plasma concentrations of N‑desmethylclobazam, the active metabolite of clobazam [see Clinical Pharmacology ( 12.3 )], which may increase the risk of clobazam-related adverse reactions [see Adverse Reactions ( 6.1 ) and Warnings and Precautions ( 5.1 , 5.2 )]. Consider a reduction in dosage of clobazam if adverse reactions known to occur with clobazam are experienced when concomitantly used with EPIDIOLEX.

Mechanism: Cannabidiol increases the amount of an active byproduct of clobazam in your blood, which can lead to more side effects.

What to do: If you experience increased side effects, your doctor may need to reduce your dose of clobazam.

moderate cenobamate

( 7.1 ) Phenobarbital and Clobazam: Reduce dosage as needed when used concomitantly with XCOPRI. phenobarbital ↑ plasma concentrations Because of a potential for an increase in the risk of adverse reactions from these drugs, consider a reduction in dosage of phenobarbital or clobazam, as clinically appropriate, when used concomitantly with XCOPRI. desmethylclobazam, the active metabolite of clobazam ↑ plasma concentrations CYP2B6 Substrates ↓ plasma concentrations Because of a potential for reduced efficacy of these drugs, increase the dosage of CYP2B6 or CYP3A4 substrates, as needed, when ...

Mechanism: Cenobamate increases the level of the active part of clobazam in your bloodstream. This can lead to more side effects from the clobazam.

What to do: Your doctor should consider lowering your clobazam dose if you are taking both of these medications.

Dosage adjustment of clobazam oral suspension 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 )].

Mechanism: Omeprazole slows down the liver's ability to process clobazam. This can cause the amount of clobazam in your body to rise to higher levels.

What to do: Your doctor may need to lower your clobazam dose while you are taking omeprazole. Watch for increased side effects like extreme sleepiness.

Dosage adjustment of clobazam oral suspension 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 )].

Mechanism: Fluconazole blocks the specific enzyme that clears clobazam from your system. This makes the clobazam stay in your body longer and can increase its effects.

What to do: Your healthcare provider may need to adjust your clobazam dosage. Let your doctor know if you feel more tired or dizzy than usual.

Dosage adjustment of clobazam oral suspension 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 )].

Mechanism: Fluvoxamine interferes with how your body breaks down clobazam. This can lead to a buildup of clobazam in your bloodstream.

What to do: Your doctor might need to change your dose of clobazam to keep it at a safe level. Monitor yourself for increased drowsiness or trouble with coordination.

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Common Questions

Can I drink alcohol while taking clobazam?
No, drinking alcohol while taking clobazam can increase sleepiness and other side effects.
What should I do if I have a rash while taking clobazam?
Stop taking clobazam and call your doctor right away if you get a rash.
Can clobazam cause suicidal thoughts?
Yes, clobazam may increase the risk of suicidal thoughts or behaviors. Tell your doctor right away if you have any of these thoughts.
How long does it take for clobazam to start working?
It takes about 5 days for clobazam and 9 days for its active ingredient to reach a steady level in your body.
Can I stop taking clobazam suddenly?
No, do not stop taking clobazam suddenly. Your doctor will slowly lower your dose to prevent withdrawal symptoms.
Does clobazam interact with birth control pills?
Yes, clobazam can make birth control pills less effective. Talk to your doctor about using other forms of birth control.
What should I do if my child is too sleepy while taking clobazam?
Tell your doctor if your child is too sleepy while taking clobazam. The doctor may need to adjust the dose.
How long can I use the bottle of oral suspension after opening it?
Use the bottle of oral suspension within 90 days of first opening it. Then, throw away any remaining medicine.
What should I do if I lose the oral syringe?
Each carton includes two syringes. Use the second syringe if the first one is damaged or lost.
Can clobazam cause problems with breathing?
Yes, clobazam can cause slowed or shallow breathing, especially when taken with opioids.
What are the common side effects of clobazam?
The most commonly reported side effects of clobazam include Constipation, Sleepiness or drowsiness, Fever, Sluggishness, Drooling. Based on 16,662 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does clobazam interact with other medications?
Yes, clobazam has 6 known drug interactions. Notable interactions include cannabidiol, cenobamate, omeprazole. Always inform your doctor about all medications you are taking.
What drug class is clobazam?
clobazam belongs to the Benzodiazepine (Anticonvulsant) drug class. It requires a prescription (Rx). Clobazam oral suspension is used to treat seizures in people 2 years and older who have Lennox-Gastaut syndrome (LGS).
Is there a generic version of clobazam?
Yes, generic clobazam is available from 15 manufacturers. The generic costs $0.24 per unit compared to $28.58 for the brand version, saving approximately 99%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.
Is clobazam safe during pregnancy?
Clobazam may harm your unborn baby. If you are pregnant or plan to become pregnant, talk to your doctor. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has clobazam been recalled?
There is 1 recall associated with clobazam products. Presence of Foreign Tablets/Capsules. Check the recalls section below for full details and affected products.

Active Recalls

Class II January 7, 2025

Presence of Foreign Tablets/Capsules

Amerisource Health Services LLC

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What the FDA Data Shows for clobazam

The FDA label for clobazam (sold under brand names such as Onfi, Sympazan) classifies it as a prescription-only medication in the Benzodiazepine (Anticonvulsant) class. Clobazam oral suspension is used to treat seizures in people 2 years and older who have Lennox-Gastaut syndrome (LGS). Official labeling lists 5 commonly reported side effects, including Constipation, Sleepiness or drowsiness, Fever.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 16,662 voluntary reports. The database also lists 6 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.24 versus $28.58 for the brand — a 99% generic savings.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: December 27, 2024

All federal data sources used on this page