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 tablet delayed release, oral tablet enteric coated

Along with its needed effects, acamprosate 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 acamprosate:

More common
  • Extreme feeling of sadness or emptiness
  • fear
  • severe depression
Symptoms of Overdose

Get emergency help immediately if any of the following symptoms of overdose occur while taking acamprosate:

  • Abdominal pain
  • confusion
  • constipation
  • diarrhea
  • dry mouth
  • headache
  • incoherent speech
  • increased urination
  • metallic taste
  • muscle weakness
  • nausea
  • thirst
  • unusual tiredness
  • vomiting
  • weight loss

Some side effects of acamprosate 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
  • Discouragement
  • feeling sad
  • irritability
  • lack of appetite
  • lack or loss of strength
  • loss of interest or pleasure
  • nervousness
  • sleeplessness
  • tiredness
  • trouble concentrating
  • trouble sleeping
Less common
  • Accidental injury
  • bloated or full feeling
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • dizziness
  • dry mouth
  • excess air or gas in stomach or intestines
  • itching skin
  • pain
  • passing gas
  • sweating

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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