Acamprosate Side Effects

Some side effects of acamprosate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to acamprosate: oral delayed release tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking acamprosate: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effects such as:

• mood or behavior changes;

• thoughts about hurting yourself;

• severe anxiety or depression;

• feeling like you might pass out;

• fast or pounding heartbeats;

• swelling, weight gain, feeling short of breath;

• confusion, increased thirst; or

• urinating less than usual or not at all.

Less serious side effects of acamprosate may include:

• nausea, vomiting, stomach pain, loss of appetite;

• constipation, diarrhea;

• headache, dizziness, drowsiness;

• vision problems;

• problems with memory or thinking;

• weakness, cold or flu-like symptoms;

• back pain, joint or muscle pain;

• dry mouth, decreased or distorted sense of taste;

• sleep problems (insomnia);

• impotence, loss of interest in sex;

• sweating, mild skin rash; or

• numbness or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to acamprosate: oral delayed release tablet

Gastrointestinal

Gastrointestinal side effects have frequently included anorexia (3%), diarrhea (16%), flatulence (3%), nausea (4%), dry mouth (2%), vomiting, dyspepsia, constipation, taste perversion, abdominal pain and increased appetite. Gastroenteritis, gastritis, dysphagia, eructation, gastrointestinal hemorrhage, pancreatitis, rectal hemorrhage, esophagitis and hematemesis have also been reported. Melena, stomach ulcer, cholecystitis, colitis, increased salivation, duodenal ulcer, enlarged abdomen, and mouth ulceration have been reported rarely.

Diarrhea was the only side effect associated with a drop out rate of greater than 1%, when compared to placebo, in clinical studies.

Nervous system

Nervous system side effects have frequently included anxiety/nervousness (6%), dizziness (3%), insomnia (7%), paresthesia (2%), somnolence, decreased libido, amnesia, abnormal thinking and tremor. Convulsions, migraine, confusion, increased libido, vertigo, withdrawal syndrome, apathy, neuralgia and hypesthesia have also been reported. Alcohol craving, hyperkinesia, twitching, torticollis and encephalopathy have been reported rarely.

Cardiovascular

Cardiovascular side effects have frequently included palpitations, vasodilation, hypertension and syncope. Hypotension, tachycardia, hemorrhage, angina pectoris, varicose veins, myocardial infarct, phlebitis and postural hypotension have also been reported. Heart failure, mesenteric arterial occlusion, cardiomyopathy, deep thrombophlebitis and shock have been reported rarely.

Other

Other side effects have frequently included accidental injury/fractures (3%), asthenia (6%), pain (3%), headache, back pain, chest pain and suicide attempt. Tinnitus, deafness, fever, intentional overdose, malaise, abscess, neck pain, hernia and intentional injury have also been reported. Ascites, face edema, photosensitivity reaction and sudden death have been reported rarely.

Hematologic

Hematologic side effects have included anemia, ecchymosis, eosinophilia, lymphocytosis and thrombocytopenia. Leukopenia, lymphadenopathy and monocytosis have been reported rarely.

Genitourinary

Genitourinary side effects have frequently included impotence. Metrorrhagia, urinary frequency, urinary tract infection, sexual function abnormality, urinary incontinence and vaginitis have also been reported. Kidney calculus, abnormal ejaculation, hematuria, menorrhagia, nocturia, polyuria and urinary urgency have been reported rarely.

Metabolic

Metabolic side effects have frequently included peripheral edema and weight gain. Weight loss, hyperglycemia, gout, thirst, hyperuricemia, diabetes mellitus, avitaminosis, bilirubinemia have also been reported. Increased creatinine, hyponatremia and increased lactic dehydrogenase have been reported rarely. Hypercalcemia has been reported in cases of chronic overdose.

Musculoskeletal

Musculoskeletal side effects have frequently included myalgia and arthralgia. Leg cramps have also been reported. Rheumatoid arthritis and myopathy have been reported rarely.

Dermatologic

Dermatologic side effects have frequently included pruritus (4%), sweating (2%) and rash. Acne, eczema, alopecia, maculopapular rash, dry skin, urticaria, exfoliative dermatitis and vesiculobullous rash have also been reported. Psoriasis has been reported rarely. There is a single case report of a possible association of erythema multiforme with acamprosate.

A 40-year-old woman with cirrhosis of the liver presented with a possible case of erythema multiforme after 10 days of therapy. While it may be probable that acamprosate was the cause, it is also possible that this outbreak could have been caused by the herpes simplex virus.

Endocrine

Endocrine side effects have rarely included goiter and hypothyroidism.

Hepatic

Hepatic side effects have frequently included increased SGOT and increased SGPT. Abnormal liver function tests, liver cirrhosis, and hepatitis have also been reported. Increases in alkaline phosphatase have been reported rarely.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction.

Immunologic

Immunologic side effects have frequently included infection, flu syndrome and chills.

Ocular

Ocular side effects have frequently included abnormal vision. Ophthalmitis, diplopia and photophobia have been reported rarely.

Renal

Renal side effects have rarely included acute kidney failure.

Acute kidney failure has been reported in at least 3 patients. While there has been no causal relationship found between these incidents and acamprosate therapy, a temporal association has been reported by the manufacturer.

Respiratory

Respiratory side effects have frequently included rhinitis, increased cough, dyspnea, pharyngitis and bronchitis. Asthma, epistaxis and pneumonia have also been reported.

Laryngismus and pulmonary embolus have been reported rarely.

Psychiatric

Psychiatric side effects have included depression (5%), suicidal ideation, hostility, agitation, neurosis, abnormal dreams and hallucinations. Psychosis, depersonalization, paranoid reaction, and manic reaction have been reported rarely.

Oncologic

Oncologic side effects have rarely included hepatic carcinoma.

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