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Banzel

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Banzel

Banzel

Banzel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Banzel (rufinamide) is used in combination with other medications to treat children with Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems. It is an anti-epileptic medication (anticonvulsant). Common side effects include drowsiness, dizziness, loss of coordination, trouble walking, tiredness, headache, nausea, vomiting, loss of appetite, or blurred/double vision.

The starting daily dose of Banzel for children four years and older is 10 mg/kg/day taken in two equally divided doses. The dose is increased approximately 10 mg/kg every other day to 45 mg/kg/day or 3200 mg/day, whichever is less, taken in two equally divided doses. The adult starting daily dose is 400-800 mg/day taken in two equally divided doses. The dose is increased by 400-800 mg every other day to 3200 mg/day, administered in two equally divided doses. Banzel may interact with carbamazepine, phenobarbital, phenytoin, or valproic acid. Tell your doctor all medications you use. During pregnancy, Banzel should be used only when prescribed. This medication may pass into breast milk. Consult your doctor before breastfeeding.

Our Banzel (rufinamide) 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.

Banzel 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, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, agitated, hostile, aggressive, restless, irritable, hyperactive, talkative, or have thoughts about suicide or hurting yourself.

Stop using rufinamide and call your doctor at once if you have any of these serious side effects:

  • fever, swollen glands, body aches, flu symptoms, feeling very weak or tired;
  • painful sores in or around your eyes or mouth, sore throat, trouble swallowing;
  • loss of balance or coordination, trouble walking;
  • skin rash, easy bruising or bleeding, severe tingling, numbness, pain, severe muscle pain or weakness;
  • upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • chest pain, irregular heart rhythm, feeling short of breath;
  • confusion, nausea and vomiting, swelling, rapid weight gain;
  • lower back pain, bloody urine, urinating less than usual;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
  • new or worsening cough with fever, trouble breathing; or
  • worsening of seizures.

Less serious side effects may include:

  • headache;
  • dizziness, drowsiness;
  • increased or decreased appetite;
  • nausea, vomiting;
  • stuffy nose, sinus pain; or
  • blurred vision.

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.

Read the entire detailed patient monograph for Banzel (Rufinamide Tablets) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Banzel Overview - Patient Information: Side Effects

SIDE EFFECTS: Drowsiness, dizziness, loss of coordination, trouble walking, tiredness, headache, nausea, vomiting, loss of appetite, or blurred/double vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor immediately if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.

Tell your doctor immediately if any of these rare but very serious side effects occur: stomach/abdominal pain, yellowing eyes/skin, dark urine, bloody urine, swollen glands.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, fever, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Banzel (Rufinamide Tablets)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Banzel FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Controlled Trials

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.

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 [see WARNINGS AND PRECAUTIONS] 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 (rufinamide tablets) as adjunctive therapy [see WARNINGS AND PRECAUTIONS]

Somnolence was reported in 24.3% of BANZEL (rufinamide tablets) -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 (rufinamide tablets) -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 (rufinamide tablets) -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 (rufinamide tablets) -treated patients, respectively, and in no placebo patients. Balance disorder and abnormal coordination were each reported in 0% of BANZEL (rufinamide tablets) -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 (rufinamide tablets) -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.

Table 2 lists treatment-emergent adverse reactions that occurred in at least 3% of pediatric patients with epilepsy treated with BANZEL (rufinamide tablets) in controlled adjunctive studies and were numerically more common in patients treated with BANZEL (rufinamide tablets) than placebo.

At the target dose of 45 mg/kg/day for adjunctive therapy in children, the most commonly observed ( ≥ 3%) adverse reactions with an incidence greater than in placebo, for BANZEL (rufinamide tablets) were somnolence, vomiting and headache.

Table 2: Incidence (%) of Treatment-Emergent Adverse Reactions in all Pediatric Double-Blind Adjunctive Trials by Preferred Term at the Recommended Dose of 45 mg/kg/day (Adverse Reactions occurred in at least 3% of BANZEL (rufinamide tablets) -treated patients and occurred more frequently than in Placebo Patients)

Preferred Term BANZEL (rufinamide tablets)
(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 3 lists treatment-emergent adverse reactions that occurred in at least 3% of adult patients with epilepsy treated with BANZEL (rufinamide tablets) (up to 3200mg/day) in adjunctive controlled studies and were numerically more common in patients treated with BANZEL (rufinamide tablets) than placebo. In these studies, either BANZEL (rufinamide tablets) or placebo was added to current AED therapy.

At all doses studied of up to 3200 mg/day given as adjunctive therapy in adults, the most commonly observed ( ≥ 3%) adverse reactions, and with the greatest increase in incidence compared to placebo, for BANZEL (rufinamide tablets) were dizziness, fatigue, nausea, diplopia, vision blurred, and ataxia.

Table 3: Incidence (%) of Treatment-Emergent Adverse Reactions in all Adult Double-Blind Adjunctive Trials (up to 3200mg/day) by Preferred Term (Adverse Reactions occurred in at least 3% of BANZEL (rufinamide tablets) -treated patients and occurred more frequently than in Placebo Patients)

Preferred Term BANZEL (rufinamide tablets)
(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 (rufinamide tablets) 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 (rufinamide tablets) ( > 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 (rufinamide tablets) 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 (rufinamide tablets) ( > 1%) used as adjunctive therapy are presented in Table 4.

Table 4: Adverse Reactions Most Commonly Leading to Discontinuation in Double-Blind Adjunctive Trials (At The Recommended Dose of 45mg/kg/day) in Pediatric Patients

Preferred Term BANZEL (rufinamide tablets)
(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 (rufinamide tablets) 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 (rufinamide tablets) ( > 1%) used as adjunctive therapy are presented in Table 5.

Table 5: Adverse Reactions Most Commonly Leading to Discontinuation in Double-Blind Adjunctive Trials (up to 3200 mg/day) in Adult Patients

Preferred Term BANZEL (rufinamide tablets)
(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 (rufinamide tablets) has been administered to 1978 individuals during all epilepsy clinical trials (placebo­controlled 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 (rufinamide tablets) 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.

Read the entire FDA prescribing information for Banzel (Rufinamide Tablets) »

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Banzel - User Reviews

Banzel User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Banzel sorted by most helpful. Patient Discussions FAQs

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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