Applies to acamprosate: oral tablets.

Side effects include:

Diarrhea and asthenia.

For Healthcare Professionals

Applies to acamprosate: oral delayed release tablet.

General

The most commonly reported side effects included diarrhea, insomnia, anxiety, depression, and asthenia.^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (up to 17%)

Common (1% to 10%): Abdominal pain, constipation, dry mouth, dyspepsia, flatulence, nausea, vomiting

Uncommon (0.1% to 1%): Dysphagia, eructation, esophagitis, gastritis, gastroenteritis, gastrointestinal hemorrhage, hematemesis, nausea and vomiting, pancreatitis, rectal hemorrhage

Rare (0.01% to 0.1%): Abdomen enlarged, ascites, cholecystitis, colitis, duodenal ulcer, increased salivation, melena, mouth ulceration, stomach ulcer^[Ref]

Nervous system

Common (1% to 10%): Amnesia, dizziness, headache, paresthesia, somnolence, syncope, taste perversion, tremor

Uncommon (0.1% to 1%): Convulsion, hypesthesia, migraine, neuralgia, vertigo

Rare (0.01% to 0.1%): Encephalopathy, hyperkinesia, twitching^[Ref]

Psychiatric

Common (1% to 10%): Abnormal thinking, anxiety, depression, insomnia, libido decreased, suicide attempt

Uncommon (0.1% to 1%): Abnormal dreams, agitation, apathy, confusion, hallucinations, hostility, intentional injury, intentional overdose, libido increased, neurosis, suicidal ideation, withdrawal syndrome

Rare (0.01% to 0.1%): Alcohol craving, depersonalization, manic reaction, paranoid reaction, psychosis

Frequency not reported: Nervousness^[Ref]

Cardiovascular

Common (1% to 10%): Chest pain, hypertension, palpitations, peripheral edema, vasodilation

Uncommon (0.1% to 1%): Angina pectoris, hemorrhage, hypotension, myocardial infarct, phlebitis, postural hypotension, tachycardia, varicose vein

Rare (0.01% to 0.1%): Cardiomyopathy, deep thrombophlebitis, heart failure, mesenteric arterial occlusion, shock^[Ref]

Respiratory

Common (1% to 10%): Bronchitis, cough increased, dyspnea, pharyngitis, rhinitis

Uncommon (0.1% to 1%): Asthma, epistaxis, pneumonia

Rare (0.01% to 0.1%): Laryngismus, pulmonary embolus^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, maculopapular rash, rash, sweating

Uncommon (0.1% to 1%): Acne, alopecia, dry skin, ecchymosis, eczema, exfoliative dermatitis, urticaria, vesiculobullous rash/vesiculobullous eruptions

Rare (0.01% to 0.1%): Face edema, photosensitivity reaction, psoriasis^[Ref]

Other

Common (1% to 10%): Accidental injury, asthenia, chills, pain

Uncommon (0.1% to 1%): Deafness, fever, hernia, malaise, tinnitus

Rare (0.01% to 0.1%): Sudden death^[Ref]

Metabolic

Common (1% to 10%): Anorexia, increased appetite, weight gain

Uncommon (0.1% to 1%): Avitaminosis, diabetes mellitus, gout, hyperglycemia, hyperuricemia, thirst, weight loss

Rare (0.01% to 0.1%): Hyponatremia, lactic dehydrogenase increased^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, myalgia

Uncommon (0.1% to 1%): Leg cramps, neck pain

Rare (0.01% to 0.1%): Myopathy, rheumatoid arthritis, torticollis

Frequency not reported: Fracture^[Ref]

Genitourinary

Common (1% to 10%): Frigidity, impotence

Uncommon (0.1% to 1%): Metrorrhagia, sexual function abnormal, urinary frequency, urinary incontinence, urinary tract infection, vaginitis

Rare (0.01% to 0.1%): Abnormal ejaculation, hematuria, menorrhagia, nocturia, polyuria, urinary urgency^[Ref]

Immunologic

Common (1% to 10%): Flu syndrome, infection

Uncommon (0.1% to 1%): Abscess^[Ref]

Ocular

Common (1% to 10%): Abnormal vision

Uncommon (0.1% to 1%): Amblyopia

Rare (0.01% to 0.1%): Diplopia, ophthalmitis, photophobia^[Ref]

Hepatic

Uncommon (0.1% to 1%): ALT increased, AST increased, bilirubinemia, hepatitis, liver cirrhosis, liver function tests abnormal

Rare (0.01% to 0.1%): Alkaline phosphatase increased^[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, eosinophilia, lymphocytosis, thrombocytopenia

Rare (0.01% to 0.1%): Leukopenia, lymphadenopathy, monocytosis^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction

Very rare (less than 0.01%): Anaphylactic reactions, angioedema, hypersensitivity reactions^[Ref]

Renal

Rare (0.01% to 0.1%): Creatinine increased, kidney calculus

Postmarketing reports: Acute kidney failure^[Ref]

Acute kidney failure was reported in 3 patients and was temporally associated with treatment.^[Ref]

Endocrine

Rare (0.01% to 0.1%): Goiter, hypothyroidism^[Ref]

Oncologic

Rare (0.01% to 0.1%): Carcinoma of liver^[Ref]