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Felbamate Side Effects

Medically reviewed by Drugs.com. Last updated on Aug 14, 2023.

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.

Serious side effects of Felbamate

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

Less common

Rare

Other side effects of Felbamate

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

Less common

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[Ref]

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[Ref]

Hepatic

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

Postmarketing reports: Hepatitis, hepatic failure, hepatorenal syndrome[Ref]

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)[Ref]

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[Ref]

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[Ref]

Genitourinary

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

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

Hypersensitivity

Rare (less than 0.1%): Anaphylactoid reaction[Ref]

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[Ref]

Immunologic

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

Postmarketing reports: Lupus syndrome[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Dystonia

Postmarketing reports: Rigors, arthralgia, muscle weakness, involuntary muscle contraction, rhabdomyolysis[Ref]

Ocular

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

Postmarketing reports: Nystagmus, hemianopsia, conjunctivitis[Ref]

Oncologic

Postmarketing reports: Neoplasm[Ref]

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[Ref]

Psychiatric

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

Common (1% to 10%): Anxiety, nervousness, stupor, abnormal thinking, emotional lability, 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[Ref]

Renal

Postmarketing reports: Acute renal failure, nephrosis, abnormal renal function[Ref]

Respiratory

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

Postmarketing reports: Respiratory depression[Ref]

References

1. Product Information. Felbamate (felbamate). Amneal Pharmaceuticals. 2016.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.