Banzel Side Effects
Generic Name: rufinamide
Please note - some side effects for Banzel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Banzel - for the Consumer
Banzel
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Banzel:
Seek medical attention right away if any of these SEVERE side effects occur when using Banzel:Dizziness; drowsiness; headache; nausea; tiredness; vomiting.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); appetite changes; behavioral, mental, or mood changes (eg, aggression, agitation, anger, anxiety, depression, mania); blood in the urine; changes in the amount of urine produced; blurred vision or other vision changes; decreased coordination or trouble walking; fever; irregular heartbeat; new or worsening seizures; severe or persistent dizziness, drowsiness, tiredness, or weakness; sore throat; suicidal thoughts or attempts; tremor; trouble sleeping.
Banzel Side Effects - for the Professional
Banzel
Placebo-controlled double-blind studies were performed in adults and in pediatric patients, down to age of 4, in other forms of epilepsy, in addition to the trial in Lennox-Gastaut syndrome. Data on CNS Reactions from the Lennox-Gastaut study are presented first. Because there is no reason to suspect that adverse reactions would substantially differ between these patient populations, safety data from all of these controlled studies are then presented. Most of these adverse reactions were mild to moderate and transient in nature.
Common central nervous system reactions in the controlled trial of patients 4 years or older with Lennox-Gastaut syndrome treated with Banzel as adjunctive therapy
:
Somnolence was reported in 24.3% of Banzel-treated patients compared to 12.5% of placebo patients and led to study discontinuation in 2.7% of treated patients compared to 0% of placebo patients. Fatigue was reported in 9.5% of Banzel-treated patients compared to 7.8% of placebo patients. It led to study discontinuation in 1.4% of treated patients and 0% of placebo patients.
Dizziness was reported in 2.7% of Banzel-treated patients compared to 0% of placebo patients, and did not lead to study discontinuation.
Ataxia and gait disturbance were reported in 5.4% and 1.4% of Banzel-treated patients, respectively, and in no placebo patients. Balance disorder and abnormal coordination were each reported in 0% of Banzel-treated patients and 1.6% of placebo patients. None of these reactions led to study discontinuation.
All Adverse Reactions for All Treated Patients with Epilepsy, Double-blind Adjunctive Therapy Studies: The most commonly observed (≥10%) adverse reactions in Banzel-treated patients, when used as adjunctive therapy at all doses studied (200 to 3200 mg/day) with a higher frequency than in placebo were: headache, dizziness, fatigue, somnolence, and nausea.
At the target dose of 45 mg/kg/day in children, the most commonly observed (≥5%) adverse reactions in Banzel-treated patients, given as adjunctive therapy, with a higher frequency than placebo were: somnolence, vomiting, headache, fatigue, dizziness, nausea, and convulsion.
At doses up to 3200 mg/day in adults, the most commonly observed (≥5%) adverse reactions in Banzel-treated patients, given as adjunctive therapy, at all doses studied, with a higher frequency than placebo were: headache, dizziness, fatigue, nausea, somnolence, diplopia, nasopharyngitis, tremor, nystagmus, vision blurred and vomiting.
Table 4 lists treatment-emergent adverse reactions that occurred in at least 3% of pediatric patients with epilepsy treated with Banzel in controlled adjunctive studies and were numerically more common in patients treated with Banzel than placebo.
| Preferred Term | Banzel (N=187) % |
Placebo (N=182) % |
|---|---|---|
| Somnolence | 17 | 9 |
| Vomiting | 17 | 7 |
| Headache | 16 | 8 |
| Fatigue | 9 | 8 |
| Dizziness | 8 | 6 |
| Nausea | 7 | 3 |
| Influenza | 5 | 4 |
| Nasopharyngitis | 5 | 3 |
| Decreased Appetite | 5 | 2 |
| Rash | 4 | 2 |
| Ataxia | 4 | 1 |
| Diplopia | 4 | 1 |
| Bronchitis | 3 | 2 |
| Sinusitis | 3 | 2 |
| Psychomotor Hyperactivity | 3 | 1 |
| Abdominal Pain Upper | 3 | 2 |
| Aggression | 3 | 2 |
| Ear Infection | 3 | 1 |
| Disturbance in Attention | 3 | 1 |
| Pruritis | 3 | 0 |
Table 5 lists treatment-emergent adverse reactions that occurred in at least 3% of adult patients with epilepsy treated with Banzel (up to 3200mg/day) in adjunctive controlled studies and were numerically more common in patients treated with Banzel than placebo. In these studies, either Banzel or placebo was added to current AED therapy.
| Preferred Term | Banzel (N=823) % |
Placebo (N=376) % |
|---|---|---|
| Headache | 27 | 26 |
| Dizziness | 19 | 12 |
| Fatigue | 16 | 10 |
| Nausea | 12 | 9 |
| Somnolence | 11 | 9 |
| Diplopia | 9 | 3 |
| Tremor | 6 | 5 |
| Nystagmus | 6 | 5 |
| Vision Blurred | 6 | 2 |
| Vomiting | 5 | 4 |
| Ataxia | 4 | 0 |
| Abdominal Pain Upper | 3 | 2 |
| Anxiety | 3 | 2 |
| Constipation | 3 | 2 |
| Dyspepsia | 3 | 2 |
| Back Pain | 3 | 1 |
| Gait Disturbance | 3 | 1 |
| Vertigo | 3 | 1 |
Discontinuation in Controlled Clinical Studies
In controlled double-blind adjunctive clinical studies, 9.0% of patients receiving Banzel as adjunctive therapy and 4.4% receiving placebo discontinued as a result of an adverse reaction. The adverse reactions most commonly leading to discontinuation of Banzel (>1%) used as adjunctive therapy were generally similar in adults and children.
In pediatric double-blind adjunctive clinical studies, 8.0% of patients receiving Banzel as adjunctive therapy and 2.2% receiving placebo discontinued as a result of an adverse reaction. The adverse reactions most commonly leading to discontinuation of Banzel (>1%) used as adjunctive therapy are presented in Table 6.
| Preferred Term | Banzel (N=187) % |
Placebo (N=182) % |
|---|---|---|
| Convulsion | 2 | 1 |
| Rash | 2 | 1 |
| Fatigue | 2 | 0 |
| Vomiting | 1 | 0 |
In adult double-blind adjunctive clinical studies (up to 3200 mg/day), 9.5% of patients receiving Banzel as adjunctive therapy and 5.9% receiving placebo discontinued as a result of an adverse reaction. The adverse reactions most commonly leading to discontinuation of Banzel (>1%) used as adjunctive therapy are presented in Table 7.
| Preferred Term | Banzel (N=823) % |
Placebo (N=376) % |
|---|---|---|
| Dizziness | 3 | 1 |
| Fatigue | 2 | 1 |
| Headache | 2 | 1 |
| Nausea | 1 | 0 |
| Ataxia | 1 | 0 |
Other Adverse Events Observed During Clinical Trials
Banzel has been administered to 1978 individuals during all epilepsy clinical trials (placebo-controlled and open-label). Adverse events occurring during these studies were recorded by the investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of patients having adverse events, these events were grouped into standardized categories using the MedDRA dictionary. Adverse events occurring at least three times and considered possibly related to treatment are included in the System Organ Class listings below. Terms not included in the listings are those already included in the tables above, those too general to be informative, those related to procedures, and terms describing events common in the population. Some events occurring fewer than 3 times are also included based on their medical significance. Because the reports include events observed in open label, uncontrolled observations, the role of Banzel in their causation cannot be reliably determined.
Events are classified by body system and listed in order of decreasing frequency as follows: frequent adverse events- those occurring in at least 1/100 patients; infrequent adverse events- those occurring in 1/100 to 1/1000 patients; rare- those occurring in fewer than 1/1000 patients.
Blood and Lymphatic System Disorders: Frequent: anemia. Infrequent: lymphadenopathy, leukopenia, neutropenia, iron deficiency anemia, thrombocytopenia.
Cardiac Disorders: Infrequent: bundle branch block right, atrioventricular block first degree
Metabolic and Nutritional Disorders: Frequent: decreased appetite, increased appetite.
Renal and Urinary Disorders: Frequent: pollakiuria. Infrequent: urinary incontinence, dysuria, hematuria, nephrolithiasis, polyuria, enuresis, nocturia, incontinence.
TopSide Effects by Body System
Nervous system
Nervous system side effects have included headache (27%), dizziness (19%), somnolence (11%), tremor (6%), ataxia (4%), gait disturbance (3%), vertigo (3%), status epilepticus, seizures, insomnia, and psychomotor hyperactivity.
General
General side effects have included fatigue (16%) and upper abdominal pain (3%).
Gastrointestinal
Gastrointestinal side effects have included nausea (12%), vomiting (5%), constipation (3%), dyspepsia (3%), abdominal pain, diarrhea, and decreased appetite.
Ocular
Ocular side effects have included diplopia (9%), blurred vision (6%), and nystagmus (6%).
Psychiatric
Psychiatric side effects have included anxiety (3%).
Musculoskeletal
Musculoskeletal side effects have included back pain (3%).
Metabolic
Metabolic side effects including decreased appetite and increased appetite have been reported frequently.
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