Note: This document contains side effect information about felbamate. Some dosage forms listed on this page may not apply to the brand name Felbatol.

Summary

Common side effects of Felbatol include: headache, nausea, vomiting, constipation, insomnia, and anorexia. Other side effects include: abdominal pain, abnormal gait, depression, diplopia, nervousness, tremor, and dysgeusia. Continue reading for a comprehensive list of adverse effects.

Applies to felbamate: oral suspension, oral tablet.

Serious side effects of Felbatol

Along with its needed effects, felbamate (the active ingredient contained in Felbatol) 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

Other side effects of Felbatol

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^[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]