Onfi Side Effects

Generic name: clobazam

Note: This document contains side effect information about clobazam. Some of the dosage forms listed on this page may not apply to the brand name Onfi.

Some side effects of Onfi may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to clobazam: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking clobazam (the active ingredient contained in Onfi) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Stop using clobazam and call your doctor at once if you have a serious side effect such as:

• confusion, hallucinations;

• fever, chills, cough with yellow or green mucus, feeling short of breath;

• feeling like you might pass out;

• pain or burning when you urinate;

• urinating less than usual or not at all; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of clobazam may include:

• drowsiness, dizziness;

• feeling weak, tired, or irritable;

• slurred speech, loss of balance or coordination;

• appetite changes;

• drooling;

• sleep problems (insomnia);

• constipation, vomiting, trouble swallowing;

• mild fever;

• dry cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to clobazam: oral tablet

Dermatologic

Dermatologic side effects reported postmarketing have included rash, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and urticaria.

Gastrointestinal

Gastrointestinal side effects have included vomiting (7%) and constipation (5%). Gastrointestinal side effects reported postmarketing have included abdominal distention.

General

General side effects have included dysphagia (2%).

Genitourinary

Genitourinary side effects have included urinary tract infection (4%).

Hematologic

Hematologic side effects reported postmarketing have included anemia, eosinophilia, leukopenia, and thrombocytopenia.

Metabolic

Metabolic side effects have included decreased appetite (3%) and increased appetite (3%).

Nervous system

Nervous system side effects have included pyrexia (13%), irritability (7%), fatigue (5%), somnolence (22%), sedation (5%), lethargy (10%), drooling (9%), ataxia (5%), psychomotor hyperactivity (4%), and dysarthria (3%).

Ocular

Ocular side effects reported postmarketing have included diplopia and blurred vision.

Psychiatric

Psychiatric side effects have included aggression (8%) and insomnia (5%). Psychiatric side effects reported postmarketing have included agitation, anxiety, apathy, confused state, depression, delirium, delusion, and hallucination.

Respiratory

Respiratory side effects have included upper respiratory tract infection (4%), pneumonia (4%), bronchitis (2%), and cough (5%). Respiratory side effects reported postmarketing have included aspiration and respiratory depression.

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