OpenClaim

Acamprosate Side Effects

The most commonly reported side effects of acamprosate include overdose, nausea, and malaise, based on 1,756 FDA adverse event reports from 2004 to 2025. 1.8% of reports found the drug to be ineffective.

Acamprosate side effects

Percentages show how often each reaction appears relative to total reports for acamprosate.

1
Overdose3.8%66
2
Nausea3.8%66
3
Malaise3.5%62
4
Asthenia3.3%58
5
Electrocardiogram Qt Prolonged3.1%55
6
Toxicity To Various Agents2.9%51
7
Intentional Overdose2.6%46
8
Off Label Use2.4%43
9
Suicidal Ideation2.2%39
10
Diarrhoea2.1%37
11
Vomiting2.1%37
12
Dizziness2.1%37
13
Hyperhidrosis2.1%36
14
Drug Abuse2.0%35
15
Injection Site Pain2.0%35

These are voluntary reports and do not establish that acamprosate caused these reactions.

Report severity

78.0%Serious1,370 reports
43.0%Hospitalizations755 reports
9.1%Fatal160 reports

Seriousness is determined by the reporter, not by OpenClaim.

Acamprosate drug interactions

Other drugs that appear in adverse event reports alongside acamprosate. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Naltrexone11.3%199
2
Quetiapine-fumarate8.9%156
3
Diazepam6.0%105
4
Mirtazapine5.0%87
5
Citalopram-hydrobromide4.8%84
6
Venlafaxine3.9%69
7
Olanzapine3.9%68
8
Gabapentin3.9%68
9
Acetaminophen3.6%64
10
Omeprazole3.4%59
11
Metformin3.3%58
12
Duloxetine-hydrochloride3.1%55
13
Lorazepam3.1%54
14
Pregabalin3.0%53
15
Atorvastatin-calcium2.9%51

Taken alongside

1
Thiamine11.3%198
2
Omeprazole7.8%137
3
Trazodone-hydrochloride7.2%127
4
Gabapentin6.4%112
5
Acetaminophen6.2%108
6
Quetiapine-fumarate5.6%99
7
Sertraline-hydrochloride5.2%91
8
Escitalopram-oxalate5.2%91
9
Folic-acid5.1%89
10
Pantoprazole-sodium5.0%87
11
Albuterol4.8%84
12
Atorvastatin-calcium4.7%82
13
Mirtazapine4.6%81
14
Naltrexone4.6%81
15
Clonazepam4.4%78

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports acamprosate side effects

41.0% of acamprosate adverse event reports involve female patients and 49.4% involve male patients. The largest age group is adult at 90%. These figures reflect who reports side effects, not underlying risk.

Sex

Female41.0%
Male49.4%
Unknown9.6%

Age group

< 20.4%
2–110.0%
12–17<0.1%
18–6490.2%
65+9.3%

What is acamprosate used for

Conditions and purposes for which patients were taking acamprosate when the adverse event was reported.

Abdominal Pain UpperAbstains From AlcoholAlcohol AbuseAlcohol DetoxificationAlcohol PoisoningAlcohol ProblemAlcohol RehabilitationAlcohol UseAlcohol Use DisorderAlcohol Withdrawal SyndromeAlcoholismAnxietyAphasiaArthralgiaAbstains From Alcohol

Showing 15 of 70 indications

Acamprosate brand names and reporting trend

Acamprosate is sold under the brand name Campral.

Brand names

Campral1,110

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking acamprosate with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.