Note: This document contains side effect information about clobazam. Some dosage forms listed on this page may not apply to the brand name Sympazan.
Applies to clobazam: oral film, oral suspension, oral tablet.
Warning
Oral route (Film; Suspension; Tablet)
Warning: Risks from Concomitant Use with Opioids; Abuse, Misuse, and Addiction: and Dependence and Withdrawal ReactionsConcomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.The use of benzodiazepines, including clobazam, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Before prescribing clobazam and throughout treatment, assess each patient's risk for abuse, misuse, and addiction.The continued use of benzodiazepines, including clobazam, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of clobazam after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue clobazam or reduce the dosage.
Serious side effects of Sympazan
Along with its needed effects, clobazam (the active ingredient contained in Sympazan) 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:
More common
- Difficulty with swallowing
- fever
- shakiness and unsteady walk
- unsteadiness, trembling, or other problems with muscle control or coordination
Less common
- Change in speech pattern
- restlessness
- slurred speech
- trouble sitting still
- trouble speaking
Incidence not known
- Agitation
- black, tarry stools
- bleeding gums
- blistering, peeling, or loosening of the skin
- blood in the urine or stools
- chest pain
- chills
- confusion as to time, place, or person
- cough
- diarrhea
- difficult or trouble breathing
- holding false beliefs that cannot be changed by fact
- irregular, fast or slow, or shallow breathing
- itching, rash, hives, or welts
- joint or muscle pain
- lack of feeling or emotion
- painful or difficult urination
- pale or blue lips, fingernails, or skin
- pinpoint red spots on the skin
- red skin lesions, often with a purple center
- red, irritated eyes
- seeing, hearing, or feeling things that are not there
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- swollen glands
- unusual bleeding or bruising
- unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
Get emergency help immediately if any of the following symptoms of overdose occur while taking clobazam:
Symptoms of overdose
- Agitation
- blurred vision
- change or loss of consciousness
- changes in patterns and rhythms of speech
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- loss of strength or energy
- nightmares
- shakiness and unsteady walk
- slurred speech
- sweating
- talkativeness
- trouble speaking
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- unusual excitement, nervousness, restlessness, or irritability
Other side effects of Sympazan
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:
More common
- Aggressive
- body aches or pain
- decreased appetite
- difficulty having a bowel movement
- drooling
- ear congestion
- irritability
- loss of voice
- runny or stuffy nose
- sneezing
- vomiting
Less common
- Bladder pain
- cloudy urine
- cough with mucus
- frequent urge to urinate
- increased appetite
- lower back or side pain
Incidence not known
- Double vision
- full or bloated feeling
- headache
- muscle spasms
- pressure in the stomach
- red skin
- swelling of the stomach area
For Healthcare Professionals
Applies to clobazam: oral film, oral suspension, oral tablet.
General
The most commonly reported side effects included sedation or somnolence, tiredness, pyrexia, and lethargy.[Ref]
Nervous system
Altered consciousness more commonly occurred in older patients, and may have been combined with respiratory disorders.
Anterograde amnesia occurred in the normal dose range, but was more frequently reported with higher doses.
Articulation disorders, gait disorders, other motor function disorders, slow speech, and/or speech disorder were typically reversible and occurred more frequently with higher doses and/or at the beginning of treatment.
Fine tremor of the fingers typically occurred at the beginning of treatment, and usually disappeared with continued treatment.
Nystagmus occurred more frequently with higher doses and/or with prolonged treatment.
Somnolence occurred more frequently with higher doses and/or at the beginning of treatment.[Ref]
Very common (10% or more): Sedation or somnolence (up to 32%), somnolence (up to 25%), lethargy (up to 15%), drooling (up to 14%)
Common (1% to 10%): Ataxia, dizziness, disturbance in attention, dysarthria, headache, psychomotor hyperactivity, sedation, slow speech, slurred speech, speech disorder, tremor
Uncommon (0.1% to 1%): Amnesia, anterograde amnesia, memory impairment
Very rare (less than 0.01%): Impaired consciousness
Frequency not reported: Articulation disorders, cognitive disorder, fine tremor of the fingers, gait disorders, indistinct speech, nystagmus, other motor function disorders, slow response to stimuli, unsteady gait/movement[Ref]
Other
Very common (10% or more): Tiredness (up to 32%), pyrexia (up to 17%)
Common (1% to 10%): Drug tolerance, fatigue
Uncommon (0.1% to 1%): Fall
Frequency not reported: Hangover, hypothermia, paradoxical reaction, reaction time slowed[Ref]
Psychiatric
Very common (10% or more): Aggression (up to 14%), irritability (up to 11%)
Common (1% to 10%): Confusion/confusional state, depression/unmasked preexisting depression, insomnia, restlessness
Uncommon (0.1% to 1%): Abnormal behavior, anxiety, delusion, loss of libido, nightmare, numbed emotions
Frequency not reported: Abuse, acute agitational states/agitation, anger, decreased libido, dependence/physical dependence/psychic dependence, difficulty falling asleep/staying asleep, euphoria, fits of rage, habituation, hallucinations, inappropriate behavior, initial insomnia, poor quality sleep, psychotic disorder/reactions, rebound phenomena, suicidal ideation, suicidal tendencies, withdrawal
Postmarketing reports: Apathy, delirium[Ref]
Dependence more commonly occurred during prolonged use.
Loss of libido was typically reversible and occurred more frequently with higher doses and/or with prolonged treatment.
Withdrawal and rebound phenomena have occurred with discontinuation of treatment.[Ref]
Respiratory
Very common (10% or more): Upper respiratory tract infection (up to 14%)
Common (1% to 10%): Bronchitis, cough, pneumonia
Very rare (less than 0.01%): Respiratory disorders
Frequency not reported: Respiratory depression, respiratory failure
Postmarketing reports: Aspiration[Ref]
Respiratory failure more commonly occurred with high doses and/or in patients with preexisting compromised respiratory function (e.g., bronchial asthma, brain damage).[Ref]
Gastrointestinal
Common (1% to 10%): Constipation, diarrhea, dry mouth, dysphagia, nausea
Frequency not reported: Vomiting
Postmarketing reports: Abdominal distention, lip edema[Ref]
Metabolic
Common (1% to 10%): Decreased/increased appetite
Uncommon (0.1% to 1%): Weight increased
Frequency not reported: Anorexia[Ref]
Dermatologic
Common (1% to 10%): Rash
Very rare (less than 0.01%): Cutaneous reactions, urticaria
Frequency not reported: Photosensitivity reaction, pruritus, Stevens-Johnson syndrome, sweating, toxic epidermal necrolysis (TEN)/fatal TEN
Postmarketing reports: Facial edema[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection
Postmarketing reports: Urinary retention[Ref]
Cardiovascular
Common (1% to 10%): Hypotension[Ref]
Ocular
Uncommon (0.1% to 1%): Diplopia
Frequency not reported: Blurred vision, visual disorders[Ref]
Diplopia was typically reversible and occurred more frequently with higher doses and/or at the beginning of treatment.[Ref]
Musculoskeletal
Frequency not reported: Muscle aches, muscle spasms/frequent muscle spasms, muscle weakness, spasm, stiffness[Ref]
Hematologic
Frequency not reported: Abnormal hematologic tests
Postmarketing reports: Anemia, eosinophilia, leukopenia, thrombocytopenia[Ref]
Hepatic
Frequency not reported: Abnormal liver function tests
Postmarketing reports: Increased liver enzymes[Ref]
Hypersensitivity
Postmarketing reports: Angioedema[Ref]
