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Felbatol

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Felbatol

Felbatol

Felbatol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Felbatol (felbamate) is used alone or in combination with other medications to treat seizures in adults with epilepsy. It is also used to treat children with Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems, and is usually given after other seizure medications have been tried without successful treatment of symptoms. It is an anti-epileptic medication (anticonvulsant). This medication is available in generic form. Common side effects include drowsiness, dizziness, nausea, vomiting, diarrhea, trouble sleeping, headache, hiccups, and loss of appetite.

The starting dose of Felbatol is 1200 mg/day in divided doses three or four times daily. A physician will monitor the patient, and increase the dosage if needed in 600-mg increments every 2 weeks to 2400 mg/day based on clinical response, and up to 3600 mg/day if indicated. Felbatol may interact with carbamazepine, clopidogrel, divalproex, oxcarbazepine, phenobarbital, phenytoin, or valproic acid. Tell your doctor all medications and supplements you use. During pregnancy, Felbatol should be used only when prescribed. This medication passes into breast milk. Consult your doctor before breastfeeding.

Our Felbatol (felbamate) 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.

Felbatol in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; fever; swollen glands; painful sores in or around your eyes or mouth; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • pale skin, weakness, easy bruising or bleeding (nosebleeds, bleeding gums);
  • fever, chills, body aches, flu symptoms;
  • fast or pounding heartbeats, feeling short of breath;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pain or burning when you urinate;
  • loss of balance or coordination; or
  • worsening of seizures.

Less serious side effects may include:

  • dizziness, drowsiness, nervousness, tired feeling;
  • headache;
  • sleep problems (insomnia);
  • changes in weight or appetite;
  • acne, mild itching or skin rash;
  • diarrhea, constipation, vomiting;
  • runny or stuffy nose;
  • blurred vision; or
  • changes in your sense of taste.

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 Felbatol (Felbamate) »

What is Patient Information Overview?

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

Felbatol Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Drowsiness, dizziness, nausea, vomiting, diarrhea, trouble sleeping, loss of coordination, headache, hiccups, and loss of appetite 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: ear pain, vision changes (e.g., blurred vision, double vision).

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: fast/irregular/pounding heartbeat, fainting.

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, 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 Felbatol (Felbamate)»

What is Prescribing information?

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

Felbatol FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.eov/medwatch .

The most common adverse reactions seen in association with Felbatol® (felbamate) in adults during monotherapy are anorexia, vomiting, insomnia, nausea, and headache. The most common adverse reactions seen in association with Felbatol® in adults during adjunctive therapy are anorexia, vomiting, insomnia, nausea, dizziness, somnolence, and headache.

The most common adverse reactions seen in association with Felbatol® in children during adjunctive therapy are anorexia, vomiting, insomnia, headache, and somnolence.

The dropout rate because of adverse experiences or intercurrent illnesses among adult felbamate patients was 12 percent (120/977). The dropout rate because of adverse experiences or intercurrent illnesses among pediatric felbamate patients was six percent (22/357). In adults, the body systems associated with causing these withdrawals in order of frequency were: digestive (4.3%), psychological (2.2%), whole body (1.7%), neurological (1.5%), and dermatological (1.5%). In children, the body systems associated with causing these withdrawals in order of frequency were: digestive (1.7%), neurological (1.4%), dermatological (1.4%), psychological (1.1%), and whole body (1.0%). In adults, specific events with an incidence of 1% or greater associated with causing these withdrawals, in order of frequency were: anorexia (1.6%), nausea (1.4%), rash (1.2%), and weight decrease (1.1%). In children, specific events with an incidence of 1% or greater associated with causing these withdrawals, in order of frequency was rash (1.1%).

Incidence in Clinical Trials

The prescriber should be aware that the figures cited in the following table cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different investigators, treatments, and uses including the use of Felbatol® (felbamate) as adjunctive therapy where the incidence of adverse events may be higher due to drug interactions. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.

Adults
Incidence in Controlled Clinical Trials-Monotherapy Studies in Adults

The table that follows enumerates adverse events that occurred at an incidence of 2% or more among 58 adult patients who received Felbatol® monotherapy at dosages of 3600 mg/day in double-blind controlled trials. Table 3 presents reported adverse events that were classified using standard WHO-based dictionary terminology.

Table 3: Adults Treatment-Emergent Adverse Event Incidence in Controlled Monotherapy Trials

  Felbatol®*
(N=58)
Low Dose Valproate**
(N=50)
Body System Event % %
Body as a Whole
  Fatigue 6.9 4.0
  Weight Decrease 3.4 0
  Face Edema 3.4 0
Central Nervous System
  Insomnia 8.6 4.0
  Headache 6.9 18.0
  Anxiety 5.2 2.0
Dermatological
  Acne 3.4 0
  Rash 3.4 0
Digestive
  Dyspepsia 8.6 2.0
  Vomiting 8.6 2.0
  Constipation 6.9 2.0
  Diarrhea 5.2 0
  SGPT Increased 5.2 2.0
Metabolic/Nutritional
  Hypophosphatemia 3.4 0
Respiratory
  Upper Respiratory Tract Infection 8.6 4.0
  Rhinitis 6.9 0
Special Senses
  Diplopia 3.4 4.0
  Otitis Media 3.4 0
Urogenital
  Intramenstrual Bleeding 3.4 0
  Urinary Tract Infection 3.4 2.0
*3600 mg/day;
** 15 mg/kg/day

Incidence in Controlled Add-On Clinical Studies in Adults

Table 4 enumerates adverse events that occurred at an incidence of 2% or more among 114 adult patients who received Felbatol® adjunctive therapy in add-on controlled trials at dosages up to 3600 mg/day. Reported adverse events were classified using standard WHO-based dictionary terminology.

Many adverse experiences that occurred during adjunctive therapy may be a result of drug interactions. Adverse experiences during adjunctive therapy typically resolved with conversion to monotherapy, or with adjustment of the dosage of other antiepileptic drugs.

Table 4: Adults Treatment-Emergent Adverse Event Incidence in Controlled Add-On Trials

Body System/Event Felbatol® Placebo
(N=114) (N=43)
% %
Body as a Whole
  Fatigue 16.8 7.0
  Fever 2.6 4.7
  Chest Pain 2.6 0
Central Nervous System
  Headache 36.8 9.3
  Somnolence 19.3 7.0
  Dizziness 18.4 14.0
  Insomnia 17.5 7.0
  Nervousness 7.0 2.3
  Tremor 6.1 2.3
  Anxiety 5.3 4.7
  Gait Abnormal 5.3 0
  Depression 5.3 0
  Paraesthesia 3.5 2.3
  Ataxia 3.5 0
  Mouth Dry 2.6 0
  Stupor 2.6 0
Dermatological
  Rash 3.5 4.7
Digestive
  Nausea 34.2 2.3
  Anorexia 19.3 2.3
  Vomiting 16.7 4.7
  Dyspepsia 12.3 7.0
  Constipation 11.4 2.3
  Diarrhea 5.3 2.3
  Abdominal Pain 5.3 0
  SGPT Increased 3.5 0
Musculoskeletal
  Myalgia 2.6 0
Respiratory
  Upper Respiratory Tract Infection 5.3 7.0
  Sinusitis 3.5 0
  Pharyngitis 2.6 0
Special Senses
  Diplopia 6.1 0
  Taste Perversion 6.1 0
  Vision Abnormal 5.3 2.3

Children
Incidence in a Controlled Add-On Trial in Children with Lennox-Gastaut Syndrome

Table 5 enumerates adverse events that occurred more than once among 31 pediatric patients who received Felbatol® up to 45 mg/kg/day or a maximum of 3600 mg/day. Reported adverse events were classified using standard WHO-based dictionary terminology.

Table 5: Children Treatment-Emergent Adverse Event Incidence in Controlled Add-On Lennox-Gastaut Trials

Body System/Event Felbatol® Placebo
(N=31) (N=27)
% %
Body as a Whole
  Fever 22.6 11.1
  Fatigue 9.7 3.7
  Weight Decrease 6.5 0
  Pain 6.5 0
Central Nervous System
  Somnolence 48.4 11.1
  Insomnia 16.1 14.8
  Nervousness 16.1 18.5
  Gait Abnormal 9.7 0
  Headache 6.5 18.5
  Thinking Abnormal 6.5 3.7
  Ataxia 6.5 3.7
  Urinary Incontinence 6.5 7.4
  Emotional Lability 6.5 0
  Miosis 6.5 0
Dermatological
  Rash 9.7 7.4
Digestive
  Anorexia 54.8 14.8
  Vomiting 38.7 14.8
  Constipation 12.9 0
  Hiccup 9.7 3.7
  Nausea 6.5 0
  Dyspepsia 6.5 3.7
Hematologic
  Purpura 12.9 7.4
  Leukopenia 6.5 0
Respiratory
  Upper Respiratory Tract Infection 45.2 25.9
  Pharyngitis 9.7 3.7
  Coughing 6.5 0
Special Senses
  Otitis Media 9.7 0

Other Events Observed in Association with the Administration of Felbatol® (felbamate)

In the paragraphs that follow, the adverse clinical events, other than those in the preceding tables, that occurred in a total of 977 adults and 357 children exposed to Felbatol® (felbamate) and that are reasonably associated with its use are presented. They are listed in order of decreasing frequency. Because the reports cite events observed in open-label and uncontrolled studies, the role of Felbatol® in their causation cannot be reliably determined.

Events are classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100-1/1000 patients; and rare events are those occurring in fewer than 1/1000 patients.

Event frequencies are calculated as the number of patients reporting an event divided by the total number of patients (N=1334) exposed to Felbatol®.

Body as a Whole: Frequent: Weight increase, asthenia, malaise, influenza-like symptoms; Rare: anaphylactoid reaction, chest pain substernal.

Cardiovascular: Frequent: Palpitation, tachycardia; Rare: supraventricular tachycardia.

Central Nervous System: Frequent: Agitation, psychological disturbance, aggressive reaction: Infrequent: hallucination, euphoria, suicide attempt, migraine.

Digestive: Frequent: SGOT increased; Infrequent: esophagitis, appetite increased; Rare: GOT elevated.

Hematologic: Infrequent: Lymphadenopathy, leukopenia, leukocytosis, thrombocytopenia, granulocytopenia; Rare: antinuclear factor test positive, qualitative platelet disorder, agranulocytosis.

Metabolic/Nutritional: Infrequent: Hypokalemia, hyponatremia, LDH increased, alkaline phosphatase increased, hypophosphatemia; Rare: creatinine phosphokinase increased.

Musculoskeletal: Infrequent: Dystonia.

Dermatological: Frequent: Pruritus; Infrequent: urticaria, bullous eruption; Rare: buccal mucous membrane swelling, Stevens-Johnson Syndrome.

Special Senses: Rare: Photosensitivity allergic reaction.

Postmarketing Adverse Event Reports

Voluntary reports of adverse events in patients taking Felbatol® (usually in conjunction with other drugs) have been received since market introduction and may have no causal relationship with the drug(s). These include the following by body system:

Body as a Whole: neoplasm, sepsis, L.E. syndrome, SIDS, sudden death, edema, hypothermia, rigors, hyperpyrexia.

Cardiovascular: atrial fibrillation, atrial arrhythmia, cardiac arrest, torsade de pointes, cardiac failure, hypotension, hypertension, flushing, thrombophlebitis, ischemic necrosis, gangrene, peripheral ischemia, bradycardia, Henoch-Schonlein purpura (vasculitis).

Central & Peripheral Nervous System: delusion, paralysis, mononeuritis, cerebrovascular disorder, cerebral edema, coma, manic reaction, encephalopathy, paranoid reaction, nystagmus, choreoathetosis, extrapyramidal disorder, confusion, psychosis, status epilepticus, dyskinesia, dysarthria, respiratory depression, apathy, concentration impaired.

Dermatological: abnormal body odor, sweating, lichen planus, livedo reticularis, alopecia, toxic epidermal necrolysis.

Digestive: (Refer to WARNINGS) hepatitis, hepatic failure, G.I. hemorrhage, hyperammonemia, pancreatitis, hematemesis, gastritis, rectal hemorrhage, flatulence, gingival bleeding, acquired megacolon, ileus, intestinal obstruction, enteritis, ulcerative stomatitis, glossitis, dysphagia, jaundice, gastric ulcer, gastric dilatation, gastroesophageal reflux.

Fetal Disorders: fetal death, microcephaly, genital malformation, anencephaly, encephalocele.

Hematologic: (Refer to WARNINGS) increased and decreased prothrombin time, anemia, hypochromic anemia, aplastic anemia, pancytopenia, hemolytic uremic syndrome, increased mean corpuscular volume (mcv) with and without anemia, coagulation disorder, embolism-limb, disseminated intravascular coagulation, eosinophilia, hemolytic anemia, leukemia, including myelogenous leukemia, and lymphoma, including T-cell and B-cell lymphoproliferative disorders.

Metabolic/Nutritional: hypernatremia. hypoglycemia, SIADH, hypomagnesemia, dehydration, hyperglycemia, hypocalcemia.

Musculoskeletal: arthralgia. muscle weakness, involuntary muscle contraction, rhabdomyolysis.

Respiratory: dyspnea, pneumonia, pneumonitis, hypoxia, epistaxis, pleural effusion, respiratory insufficiency, pulmonary hemorrhage, asthma.

Special Senses: hemianopsia. decreased hearing, conjunctivitis.

Urogenital: menstrual disorder, acute renal failure, hepatorenal syndrome, hematuria, urinary retention, nephrosis, vaginal hemorrhage, abnormal renal function, dysuria, placental disorder.

Drug Abuse And Dependence

Abuse

Abuse potential was not evaluated in human studies.

Dependence

Rats administered felbamate orally at doses 8.3 times the recommended human dose 6 days each week for 5 consecutive weeks demonstrated no signs of physical dependence as measured by weight loss following drug withdrawal on day 7 of each week.

Read the entire FDA prescribing information for Felbatol (Felbamate) »

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Felbatol - User Reviews

Felbatol 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 Felbatol 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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