Sympazan Side Effects

This medicine may cause some people to be dizzy, drowsy, or less alert than normal.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent a possible worsening of your seizures and reduce the possibility of withdrawal symptoms such as changes in behavior, discouragement, feeling sad or empty, irritability, lack of appetite, loss of interest or pleasure, trouble concentrating, seeing or hearing things that others do not see or hear, thoughts of killing oneself, trouble sleeping, unusual movements, responses, or expressions.

Symptoms of an overdose include: 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, hallucinations, loss of strength or energy, muscle pain or weakness, nightmares, pale or blue lips, fingernails, or skin, shakiness, unsteadiness, trembling, or other problems with muscle control or coordination, slurred speech, trouble in speaking, sweating, trouble breathing, trouble sleeping, unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness, unusual excitement, nervousness, restlessness, or irritability, or unusual weak feeling. Call your doctor right away if you notice these symptoms.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

If you or your child develop any unusual or strange thoughts and behavior while taking this medicine, be sure to discuss it with your doctor. Some of the changes that have occurred in people taking this medicine are like those seen in people who drink too much alcohol. Clobazam may cause confusion, worsening of depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

Birth control pills may not work as well while you are using this medicine. To keep from getting pregnant, use another form of birth control together with your birth control pills during therapy and for 28 days after you take the last dose.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Sympazan

Along with its needed effects, clobazam 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:

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:

For healthcare professionals

Applies to clobazam: oral film, oral suspension, oral tablet.

General adverse events

The most commonly reported side effects included sedation or somnolence, tiredness, pyrexia, and lethargy.^[Ref]

Nervous system

• 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]

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]

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]

See also:

Frequently asked questions

• What is the difference between Sympazan and Onfi?

Further information

Sympazan side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer