"The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain"...
Onfi Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Onfi (clobazam) tablets are for use as an add-on treatment for seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Onfi is not available as a generic drug. Onfi causes drowsiness and sedation. Onfi may slow thinking and impair motor skills. Common adverse reactions may include somnolence, sedation, fever, drooling, constipation, cough, urinary tract infection, insomnia, aggression, fatigue, upper respiratory tract infection, irritability, vomiting, problems swallowing, problems with coordination, as well as bronchitis, and pneumonia.
Onfi is available in 5 mg, 10 mg, and 20 mg strengths and can be administered whole, or crushed and mixed in applesauce. Dosing depends on body weight. It is important that people taking Onfi not drive, operate heavy machinery, or engage in other dangerous activities. Onfi can cause abuse and dependence and should not be used with alcohol. Abrupt discontinuation of Onfi should be avoided. Other serious side effects include suicidal behavior. The risk of withdrawal symptoms (for example, seizures, tremors, anxiety) is greater with higher doses. Onfi may compromise the effectiveness of some birth control medications. Women should tell their healthcare providers if they are pregnant, planning to become pregnant, or are using birth control medications. Onfi may have harmful effects on unborn babies to include breathing and feeding problems, dangerously low body temperatures, and withdrawal symptoms. It is approved for children 2 years and older.
Our Onfi Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Onfi in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 may include:
- drowsiness, dizziness;
- feeling weak, tired, or irritable;
- slurred speech, loss of balance or coordination;
- appetite changes;
- sleep problems (insomnia);
- constipation, vomiting, trouble swallowing;
- mild fever;
- dry cough.
Read the entire detailed patient monograph for Onfi (Clobazam Tablets and Oral Suspension) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Onfi FDA Prescribing Information: Side Effects
Clinically significant adverse reactions that appear in other sections of the labeling include the following:
- Somnolence or Sedation [see WARNINGS AND PRECAUTIONS]
- Potentiation of Sedation from Concomitant Use with Central Nervous System Depressants [see WARNINGS AND PRECAUTIONS]
- Withdrawal Symptoms [see WARNINGS AND PRECAUTIONS]
- Serious Dermatological Reactions [see WARNINGS AND PRECAUTIONS]
- Physical and Psychological Dependence [see WARNINGS AND PRECAUTIONS]
- Suicidal Behavior and Ideation [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
During its development for the adjunctive treatment of seizures associated with LGS, ONFI was administered to 333 healthy volunteers and 300 patients with a current or prior diagnosis of LGS, including 197 patients treated for 12 months or more. The conditions and duration of exposure varied greatly and included single- and multiple-dose clinical pharmacology studies in healthy volunteers and two double-blind studies in patients with LGS (Study 1 and 2) [see Clinical Studies ]. Only Study 1 included a placebo group, allowing comparison of adverse reaction rates on ONFI at several doses to placebo.
Adverse Reactions Leading To Discontinuation In An LGS Placebo Controlled Clinical Trial (Study 1)
The adverse reactions associated with ONFI treatment discontinuation in ≥ 1% patients in decreasing order of frequency included lethargy, somnolence, ataxia, aggression, fatigue, and insomnia.
Most Common Adverse Reactions In An LGS Placebo Controlled Clinical Trial (Study 1)
Table 3 lists the adverse reactions that occurred in ≥ 5% of ONFI treated patients (at any dose), and at a rate greater than placebo treated patients, in the randomized, double-blind, placebo-controlled, parallel group clinical study of adjunctive AED therapy for 15 weeks (Study 1).
Table 3: Adverse Reactions Reported for ≥ 5% of
Patients and More Frequently than Placebo in Any Treatment Group
|ONFI Dose Level||All ONFI
|Highc N=59 %|
|General Disorders and Administration Site Conditions|
|Infections and Infestations|
|Upper respiratory tract infection||10||10||13||14||12|
|Urinary tract infection||0||2||5||5||4|
|Metabolism and Nutrition Disorders|
|Nervous System Disorders|
|Somnolence or Sedation||15||17||27||32||26|
|a Maximum daily dose of 5 mg for ≤ 30 kg
body weight; 10 mg for > 30 kg body weight
b Maximum daily dose of 10 mg for ≤ 30 kg body weight; 20 mg for > 30 kg body weight
c Maximum daily dose of 20 mg for ≤ 30 kg body weight; 40 mg for > 30 kg body weight
Post Marketing Experience
These reactions are reported voluntarily from a population of uncertain size; therefore, it is not possible to estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions are categorized by system organ class.
Eye Disorders: Diplopia, vision blurred
Gastrointestinal Disorders: Abdominal distention
Investigations: Hepatic enzyme increased
Musculoskeletal: Muscle spasms
Psychiatric Disorders: Agitation, anxiety, apathy, confusional state, depression, delirium, delusion, hallucination
Respiratory Disorders: Aspiration, respiratory depression
Skin and Subcutaneous Tissue Disorders: Rash, urticaria
Read the entire FDA prescribing information for Onfi (Clobazam Tablets and Oral Suspension) »
Additional Onfi Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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