pharmacopeia
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Mechanism of action

Sourced from openFDA

The mechanism of action of acamprosate in maintenance of alcohol abstinence is not completely understood. Chronic alcohol exposure is hypothesized to alter the normal balance between neuronal excitation and inhibition.

GABA ANMDA Receptor

Indications

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  • Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation ( 1 , 14 ). Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support ( 1 ).ICD-10: F10.20

Contraindications

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  • Acamprosate calcium is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components ( 4.1 ). Acamprosate calcium is contraindicated in patients with severe renal impairment ( 4.2 ).contraindicated

Dosage & administration

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Recommended dose: 666 mg (two 333 mg tablets) taken three times daily ( 2 ). Dose reduction to one 333 mg tablet taken three times daily for patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min) ( 2.1 ). Acamprosate calcium delayed-release tablets are contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) ( 2.1 , 4.2 , 5.1 , 8.6 , 12.3 ). The recommended dose of acamprosate calcium delayed-release tablets is two 333 mg tablets (each dose should total 666 mg) taken three times daily. A lower dose may be effective in some patients. Although dosing may be done without regard to meals, dosing with meals was employed during clinical trials and is suggested in those patients who regularly eat three meals daily. Treatment with acamprosate calcium delayed-release tablets should be initiated as soon as possible after the period of alcohol withdrawal, when the patient has achieved abstinence, and should be maintained if the patient relapses. Acamprosate calcium delayed-release tablets should be used as part of a comprehensive psychosocial treatment program. 2.1 Dosage in Renal Impairment For patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min), a starting dose of one 333 mg tablet taken three times daily is recommended.

Warnings & precautions

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Dose reduction is required for patients with moderate renal impairment ( 5.1 ). Monitor patients for depression or suicidal ideation and prompt patients, families, and caregivers to report such symptoms to the health care provider ( 5.2 ). 5.1 Renal Impairment Treatment with acamprosate calcium in patients with moderate renal impairment (creatinine clearance of 30 to 50 mL/min) requires a dose reduction [ see Dosage and Administration (2.1) ]. Acamprosate calcium is contraindicated in patients with severe renal impairment (creatinine clearance of ≤30 mL/min) [ see Dosage and Administration (2.1) , Contraindications (4.2) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ]. 5.2 Suicidality and Depression In controlled clinical trials of acamprosate calcium, adverse events of a suicidal nature (suicidal ideation, suicide attempts, completed suicides) were infrequent overall, but were more common in acamprosate calcium-treated patients than in patients treated with placebo (1.4% vs. 0.5% in studies of 6 months or less; 2.4% vs. 0.8% in year-long studies). Completed suicides occurred in 3 of 2272 (0.13%) patients in the pooled acamprosate group from all controlled studies and 2 of 1962 patients (0.10%) in the placebo group. Adverse events coded as "depression" were reported at similar rates in acamprosate calcium-treated and placebo-treated patients.

Adverse reactions

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Common adverse events that occurred in any acamprosate calcium treatment group at a rate of 3% or greater and greater than the placebo group in controlled clinical trials with spontaneously reported adverse events are: accidental injury, asthenia, pain, anorexia, diarrhea, flatulence, nausea, anxiety, depression, dizziness, dry mouth, insomnia, paresthesia, pruritus and sweating ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals USA Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinically significant serious adverse reactions associated with acamprosate calcium described elsewhere in labeling include suicidality and depression and acute kidney failure [ see Warnings and Precautions (5.2), and Adverse Reactions (6.2) ]. The adverse event data described below reflect the safety experience in over 7000 patients exposed to acamprosate calcium for up to one year, including over 2000 acamprosate calcium-exposed patients who participated in placebo-controlled trials. Adverse Events Leading to Discontinuation In placebo-controlled trials of 6 months or less, 8% of acamprosate calcium-treated patients discontinued treatment due to an adverse event, as compared to 6% of patients treated with placebo.

Use in specific populations

Sourced from openFDA

Pregnancy: Acamprosate calcium should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus ( 8.1 ). Nursing Mothers: Caution should be exercised when acamprosate calcium is administered to a nursing woman ( 8.3 ). Renal Impairment: Dose reduction required for moderate renal impairment; contraindicated in severe renal impairment ( 2.1 , 4.2 , 5.1 , 8.6 , 12.3 ) 8.1 Pregnancy Teratogenic effects: Acamprosate calcium has been shown to be teratogenic in rats when given in doses that are approximately equal to the human dose (on a mg/m 2 basis) and in rabbits when given in doses that are approximately 3 times the human dose (on a mg/m 2 basis). Acamprosate calcium produced a dose-related increase in the number of fetuses with malformations in rats at oral doses of 300 mg/kg/day or greater (approximately equal to the maximum recommended human daily (MRHD) oral dose on a mg/m 2 basis). The malformations included hydronephrosis, malformed iris, retinal dysplasia, and retroesophageal subclavian artery. No findings were observed at an oral dose of 50 mg/kg/day (approximately one-fifth the MRHD oral dose on a mg/m 2 basis). An increased incidence of hydronephrosis was also noted in Burgundy Tawny rabbits at oral doses of 400 mg/kg/day or greater (approximately 3 times the MRHD oral dose on a mg/m 2 basis).

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption The absolute bioavailability of acamprosate calcium after oral administration is about 11%. Steady-state plasma concentrations of acamprosate are reached within 5 days of dosing.

Overdosage

Sourced from openFDA

In all reported cases of acute overdosage with acamprosate calcium (total reported doses of up to 56 grams of acamprosate calcium), the only symptom that could be reasonably associated with acamprosate calcium was diarrhea. Hypercalcemia has not been reported in cases of acute overdose. A risk of hypercalcemia should be considered in chronic overdosage only. Treatment of overdose should be symptomatic and supportive.

Approval history

Sourced from openFDA
  • Jul 16, 2013ANDAANDA202229Glenmark Pharms Ltd
  • Mar 11, 2014ANDAANDA200142Mylan
  • May 26, 2017ANDAANDA205995Zydus Pharms
  • Sep 18, 2025ANDAANDA219904Bionpharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
313 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use216.7%
  2. 2Vomiting185.8%
  3. 3Hypotension154.8%
  4. 4Asthenia144.5%
  5. 5Condition Aggravated134.2%
  6. 6Acute Kidney Injury123.8%
  7. 7Coma123.8%
  8. 8Fatigue113.5%
  9. 9Headache113.5%
  10. 10Toxicity To Various Agents113.5%
  11. 11Drug Abuse103.2%
  12. 12Overdose103.2%
  13. 13Bradycardia92.9%
  14. 14Cytolytic Hepatitis92.9%
  15. 15Depression92.9%

Literature

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Recent PubMed references pinned to Acamprosate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 51 ClinicalTrials.gov registrations naming Acamprosate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Acamprosate work?
The mechanism of action of acamprosate in maintenance of alcohol abstinence is not completely understood. Chronic alcohol exposure is hypothesized to alter the normal balance between neuronal excitation and inhibition.
What is Acamprosate used for?
According to FDA labeling, Acamprosate carries indications including: Acamprosate calcium delayed-release tablets are indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation ( 1 , 14 ). Treatment with acamprosate calcium delayed-release tablets should be part of a comprehensive management program that includes psychosocial support ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Acamprosate?
Acamprosate is classified as Drugs used in alcohol dependence, GABA A Modulators, NMDA Receptor Antagonists, Increased GABA Activity.
What are the contraindications for Acamprosate?
Acamprosate labeling lists contraindications including: Acamprosate calcium is contraindicated in patients who previously have exhibited hypersensitivity to acamprosate calcium or any of its components ( 4.1 ). Acamprosate calcium is contraindicated in patients with severe renal impairment ( 4.2 ).. Always consult the full prescribing information and a clinician.
Note. Data for acamprosate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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