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Campral Side Effects

Generic Name: acamprosate

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

For the Consumer

Applies to acamprosate: oral tablet delayed release

Along with its needed effects, acamprosate (the active ingredient contained in Campral) 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:

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

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]

References

1. "Product Information. Campral (acamprosate)." Forest Pharmaceuticals, St. Louis, MO.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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.

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