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Felbamate

Felbamate Prescription
Generic Name: felbamate (fel BAM ate)
Brand Name: Felbatol
Physician reviewed felbamate patient information - includes felbamate description, dosage and directions.

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Felbamate Drug Information:

Felbamate is an anti-epileptic medicine, also called an anticonvulsant. Felbamate is used alone or with other medications to treat seizures in adults with epilepsy. Felbamate is also used with other medications in children with Lennox-Gastaut syndrome, a severe form of childhood epilepsy that also causes developmental and behavior problems. Felbamate can cause serious side effects that may not be reversible. Felbamate should be used only for conditions that cannot be treated with a safer medicine. Learn more

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Felbamate Side Effects

In Summary

Commonly reported side effects of felbamate include: headache, nausea, vomiting, constipation, insomnia, and anorexia. Other side effects include: abdominal pain, abnormal gait, depression, diplopia, nervousness, tremor, and dysgeusia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to felbamate: oral suspension, oral tablet

Warning

Oral route (Tablet; Suspension)

Felbamate use is associated with a marked increase in the incidence of aplastic anemia, sometimes fatal. Discontinue if any evidence of bone marrow depression occurs. Liver failure resulting in death or transplant has been reported with therapy. Felbamate should not be prescribed for anyone with a history of hepatic dysfunction and should be discontinued in anyone showing signs of liver injury while on therapy. Monitor liver enzymes during therapy.

Along with its needed effects, felbamate 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 felbamate:

More common

  • Black, tarry stools
  • chest pain
  • chills
  • confusion
  • cough
  • delusions
  • dementia
  • depression
  • fever
  • loss of bladder control
  • painful or difficult urination
  • purple or red spots on the skin
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • trembling or shaking of the hands or feet
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Less common

  • Agitation, aggression, or other mood or mental changes
  • bladder pain
  • bloody or cloudy urine
  • bone pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • clumsiness or unsteadiness
  • frequent urge to urinate
  • loss of appetite
  • lower back or side pain
  • skin rash
  • swelling or puffiness of the face
  • trouble with breathing
  • unsteadiness, trembling, or other problems with muscle control or coordination

Rare

  • Continuing headache
  • continuing stomach pain
  • continuing vomiting
  • dark-colored urine
  • general feeling of tiredness or weakness
  • hives or itching
  • light-colored stools
  • muscle cramps
  • nasal congestion
  • nosebleeds or other unusual bruising or bleeding
  • pain
  • sensitivity of the skin to sunlight
  • swollen or painful glands
  • tightness in the chest
  • yellow eyes or skin

Some side effects of felbamate 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:

More common

  • Acid or sour stomach
  • bad, unusual, or unpleasant (after) taste
  • belching
  • body aches or pain
  • change in taste
  • change in walking and balance
  • constricted, pinpoint, or small pupils (black part of the eye)
  • crying
  • depersonalization
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty with sleeping
  • dizziness
  • double vision
  • dysphoria
  • ear congestion
  • euphoria
  • headache
  • heartburn
  • hiccup
  • indigestion
  • loss of appetite
  • loss of voice
  • nausea
  • paranoia
  • quick to react or overreact emotionally
  • rapidly changing moods
  • runny nose
  • seeing double
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sneezing
  • stomach discomfort, upset, or pain
  • trouble sleeping
  • unable to sleep
  • weight loss

Less common

  • Blemishes on the skin
  • blurred vision
  • decreased awareness or responsiveness
  • decreased weight
  • difficulty with moving
  • earache
  • hoarseness
  • joint pain
  • muscle aching or cramping
  • muscle pains or stiffness
  • pain or tenderness around the eyes and cheekbones
  • pimples
  • redness or swelling in the ear
  • severe sleepiness
  • swollen joints
  • tender, swollen glands in the neck
  • trouble with swallowing
  • voice changes

For Healthcare Professionals

Applies to felbamate: oral suspension, oral tablet

Nervous system

Very common (10% or more): Headache (36.8%), somnolence (19.3%), dizziness (18.4%)

Common (1% to 10%): Tremor, abnormal gait, paresthesia, ataxia

Uncommon (0.1% to 1%): Migraine

Postmarketing reports: Hyperpyrexia, paralysis, mononeuritis

Gastrointestinal

Very common (10% or more): Nausea (34.2%), vomiting (16.7%), dyspepsia (12.3%), constipation (11.4%)

Common (1% to 10%): Diarrhea, dry mouth, abdominal pain, hiccough

Uncommon (0.1% to 1%): Esophagitis

Postmarketing reports: GI hemorrhage, 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

Hepatic

Common (1% to 10%): Serum glutamic-pyruvic transaminase (SGPT) increased

Postmarketing reports: Hepatitis, hepatic failure, hepatorenal syndrome

Dermatologic

Common (1% to 10%): Acne, rash, pruritus

Uncommon (0.1% to 1%): Urticaria, bullous eruption

Rare (less than 0.1%): Buccal mucous membrane swelling, Stevens-Johnson Syndrome, photosensitivity

Postmarketing reports: Abnormal body odor, sweating, lichen planus, livedo reticularis, alopecia, toxic epidermal necrolysis (TEN)

Metabolic

Very common (10% or more): Anorexia (19.3%)

Common (1% to 10%): Weight loss, weight gain, hypophosphatemia

Uncommon (0.1% to 1%): Increased appetite, hypokalemia, hyponatremia, LDH increased, alkaline phosphatase increased

Rare (less than 0.1%): Creatinine phosphokinase increased

Postmarketing reports: Hyperammonemia, hypernatremia, hypoglycemia, SIADH, hypomagnesemia, dehydration, hyperglycemia, hypocalcemia

Hematologic

Very common (10% or more): Purpura (12.9%)

Common (1% to 10%): Leukopenia

Uncommon (0.1% to 1%): Leukocytosis, thrombocytopenia, granulocytopenia

Rare (less than 0.1%): Antinuclear factor test positive, qualitative platelet disorder, agranulocytosis

Postmarketing reports: Sepsis, increased and decreased prothrombin time, anemia, hypochromic anemia, aplastic anemia, pancytopenia, hemolytic uremic syndrome, increased mean corpuscular volume 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

Genitourinary

Common (1% to 10%): Intramenstrual bleeding, urinary tract infection, urinary incontinence

Frequency not reported: Menstrual disorder, hematuria, urinary retention, vaginal hemorrhage, dysuria

Hypersensitivity

Rare (less than 0.1%): Anaphylactoid reaction

Cardiovascular

Common (1% to 10%): Palpitation, tachycardia

Uncommon (0.1% to 1%): Lymphadenopathy

Rare (less than 0.1%): Supraventricular tachycardia

Postmarketing reports: 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), cerebrovascular disorder, cerebral edema

Immunologic

Common (1% to 10%): Influenza-like symptoms

Postmarketing reports: Lupus syndrome

Musculoskeletal

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Dystonia

Postmarketing reports: Rigors, arthralgia, muscle weakness, involuntary muscle contraction, rhabdomyolysis

Ocular

Common (1% to 10%): Diplopia, abnormal vision, miosis

Postmarketing reports: Nystagmus, hemianopsia, conjunctivitis

Oncologic

Postmarketing reports: Neoplasm

Other

Very common (10% or more): Fever (22.6%), fatigue (16.8%)

Common (1% to 10%): Otitis media, face edema, depression, taste perversion, pain, asthenia, malaise

Postmarketing reports: Edema, sudden death, hypothermia, fetal death, microcephaly, genital malformation, anencephaly, encephalocele, decreased hearing, placental disorder

Psychiatric

Very common (10% or more): Insomnia (17.5%)

Common (1% to 10%): Anxiety, nervousness, stupor, abnormal thinking, emotional liability, agitation, psychological disturbance, aggressive reaction

Uncommon (0.1% to 1%): Hallucination, euphoria, suicide attempt

Postmarketing reports: Delusion, manic reaction, paranoid reaction, confusion, psychosis, apathy, impaired concentration

Renal

Postmarketing reports: Acute renal failure, nephrosis, abnormal renal function

Respiratory

Common (1% to 10%): Upper respiratory tract infection, rhinitis, chest pain, sinusitis, pharyngitis, coughing

Postmarketing reports: Respiratory depression

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Felbamate (www.drugs.com/mtm/felbamate.html).