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Clobazam is associated with several important safety considerations that must be understood and followed closely to minimize risks.

• Risk of Abuse and Addiction: Clobazam is a controlled substance due to its potential for misuse and addiction. Misuse can lead to serious side effects, including memory issues, confusion, and muscle pain. It can also cause life-threatening respiratory depression and coma. Individuals with a personal or family history of substance use disorder or mental health problems may be at higher risk.

• Interactions with Opioids: Concurrent use of clobazam with opioid medications can cause severe drowsiness, dangerously slow breathing, coma, or even death. Only combine these medications if absolutely necessary, and your healthcare provider should prescribe the lowest effective doses for the shortest duration.

• Extreme Drowsiness: Clobazam may cause significant sleepiness, impacting concentration and reaction time. This effect is more pronounced when taken with other sedative medications or alcohol. Be cautious when engaging in activities that require alertness, such as driving.

• Withdrawal and Dependence: Stopping clobazam abruptly can lead to withdrawal symptoms, which may include nausea, tremors, sweating, and in severe cases, seizures and psychosis. Your doctor may gradually reduce your dose to prevent withdrawal.

• Serious Skin Reactions: There is a risk of life-threatening skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis. Be vigilant for symptoms like rash, blisters, or skin peeling, especially during the first two months of treatment, and seek immediate medical attention if they occur.

• Suicidal Thoughts or Behavior: Clobazam can increase the risk of suicidal thoughts and behaviors. This risk can appear early in treatment and persist throughout. It is crucial to seek help if you experience symptoms such as anxiety, panic attacks, irritability, or restlessness.

• Use During Pregnancy: Clobazam may cause side effects in newborns if used during late pregnancy, including weakness, slowed breathing, and withdrawal symptoms. Discuss the risks and benefits with your healthcare provider if you are pregnant or planning to become pregnant. Participation in the North American Antiepileptic Drug (NAAED) Pregnancy Registry is encouraged to monitor medication safety during pregnancy.

In case of any severe side effects or overdose, such as slow or difficult breathing and extreme drowsiness, seek emergency medical assistance immediately. Always take clobazam exactly as prescribed, and consult your healthcare provider before making any changes to your dosage or medication regimen.

Common side effects:

• drowsiness
• dizziness
• tiredness
• headache
• constipation
• weight gain
• drooling
• trouble sleeping
• nausea
• fever
• upper respiratory tract infection
• low energy
• vomiting
• cough

Less common but important to monitor:

• slurred speech
• trouble swallowing
• changes in appetite
• pain with urination
• problems with coordination

Serious side effects:

• severe allergic reactions
• severe skin reactions
• severe sleepiness
• severe dizziness
• signs of suicidal thoughts or behaviors

Interactions with high risk of serious adverse effects and should be avoided:

• Flumazenil
• Thioridazine

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Alprazolam
• Codeine
• Hydrocodone
• Lorazepam
• Carisoprodol
• Cyclobenzaprine
• Diphenhydramine
• Sodium Oxybate
• Orlistat
• Etravirine
• Felbamate
• Ketoconazole
• Phenytoin