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.
Common side effects of Onfi include: constipation, drowsiness, fever, sedated state, aggressive behavior, ataxia, lethargy, drooling, and irritability. Other side effects include: pneumonia, urinary tract infection, cough, bronchitis, dysarthria, dysphagia, fatigue, insomnia, decreased appetite, and increased appetite. See below for a comprehensive list of adverse effects.
Applies to clobazam: oral suspension, oral tablet
Oral route (Suspension; Tablet)
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, or death. Reserve use for patients for whom alternative therapies are inadequate and limit use to lowest possible dose and shortest possible duration. Monitor for signs or symptoms of respiratory depression and sedation.
Along with its needed effects, clobazam (the active ingredient contained in Onfi) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking clobazam:
Incidence not known
Some side effects of clobazam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to clobazam: oral film, oral suspension, oral tablet
The most commonly reported side effects were somnolence or sedation, tiredness, pyrexia, and lethargy.
Very common (10% or more): Somnolence or sedation (up to 32%), drowsiness (up to 32%), somnolence (up to 25%), lethargy (up to 15%), drooling (up to 14%), ataxia (up to 10%)
Common (1% to 10%): Dizziness, dysarthria, headache, psychomotor hyperactivity, sedation, slurred speech, tremor
Frequency not reported: Amnesia, anterograde amnesia, disorders of articulation, disturbance in attention, fine finger tremor, hangover, impairment in consciousness, memory impairment, nystagmus, potentiation of sedation from concomitant use with central nervous system depressants, sleepiness, slowed/indistinct speech, slowing of reaction time, speech disorder, unsteadiness of gait and other motor functions, unsteady movement
Very common (10% or more): Tiredness (up to 32%), pyrexia (up to 17%)
Common (1% to 10%): Fatigue
Frequency not reported: Drug tolerance, fall, hypothermia, risks from concomitant use with opioids, paradoxical reactions
Very common (10% or more): Aggression/aggressiveness (up to 14%), irritability (up to 11%)
Common (1% to 10%): Confusion, depression, insomnia
Frequency not reported: Acute agitational states, agitation, anxiety, benzodiazepine abuse, decreased libido, delusion, difficulty falling asleep/sleeping through, euphoria, fits of rage, habituation, hallucinations, inappropriate behavior, loss of libido, nightmares, numbed emotions, physical and psychological dependence, psychotic reactions, restlessness, suicidal behavior and ideations, suicidal tendencies, unmasking of preexisting depression, withdrawal symptoms/rebound phenomena
Postmarketing reports: Apathy, confusional state, delirium
Very common (10% or more): Upper respiratory tract infection (up to 14%)
Common (1% to 10%): Bronchitis, cough, pneumonia
Frequency not reported: Deterioration of respiratory insufficiency, respiratory depression, respiratory disorders, respiratory insufficiency
Postmarketing reports: Aspiration
Very common (10% or more): Constipation (up to 10%)
Common (1% to 10%): Diarrhea, dry mouth, dysphagia, nausea, vomiting
Postmarketing reports: Abdominal distention
Common (1% to 10%): Decreased appetite, increased appetite
Frequency not reported: Anorexia, appetite loss, weight gain
Common (1% to 10%): Rash
Frequency not reported: Cutaneous reaction, photosensitivity reactions, pruritus, serious dermatological reactions, Stevens-Johnson syndrome (SJS)/fatal SJS, sweating, toxic epidermal necrolysis (TEN)/fatal TEN, urticaria
Postmarketing reports: Facial and lip edema
Common (1% to 10%): Urinary tract infection
Postmarketing reports: Urinary retention
Common (1% to 10%): Hypotension
Frequency not reported: Muscle aches, muscle spasm/frequent muscle spasms, muscle stiffness, muscle weakness
Frequency not reported: Blurred vision, diplopia/double vision, visual disorders
Frequency not reported: Abnormal hematologic laboratory tests
Postmarketing reports: Anemia, eosinophilia, leukopenia, thrombocytopenia
Frequency not reported: Abnormal liver function tests
Postmarketing reports: Increased hepatic enzymes
Postmarketing reports: Angioedema
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Onfi (www.drugs.com/onfi.html).
March 28, 2020
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