What the label lists and what reports show
Acamprosate side effects
Acamprosate's FDA label lists its adverse reactions in its own words. FAERS holds 322 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is vomiting (19 reports).
- Generic listed
Check it at the source: the acamprosate FDA label on DailyMed (effective July 14, 2026, Somerset Therapeutics, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsCommon 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 Somerset Therapeutics, LLC at 1-800-417-9175, 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. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Acamprosate Calcium 1332 mg/day | Acamprosate Calcium 1998 mg/day 1 | Acamprosate Calcium Pooled 2 | Placebo |
|---|---|---|---|---|
| Number of patients in Treatment Group | 397 | 1539 | 2019 | 1706 |
| Number (%) of patients with an AE | 248 (62%) | 910 (59%) | 1231 (61%) | 955 (56%) |
| Body as a Whole | 121 (30%) | 513 (33%) | 685 (34%) | 517 (30%) |
| Accidental Injury | 17 (4%) | 44 (3%) | 70 (3%) | 52 (3%) |
| Asthenia | 29 (7%) | 79 (5%) | 114 (6%) | 93 (5%) |
| Pain | 6 ( 2%) | 56 ( 4%) | 65 (3%) | 55 (3%) |
| Digestive System | 85 (21%) | 440 (29%) | 574 (28%) | 344 (20%) |
| Anorexia | 20 ( 5%) | 35 ( 2%) | 57 ( 3%) | 44 ( 3%) |
| Diarrhea | 39 (10%) | 257 (17%) | 329 (16%) | 166 (10%) |
| Flatulence | 4 ( 1%) | 55 ( 4%) | 63 ( 3%) | 28 ( 2%) |
| Nausea | 11 ( 3%) | 69 ( 4%) | 87 ( 4%) | 58 ( 3%) |
| Nervous System | 150 (38%) | 417 (27%) | 598 (30%) | 500 (29%) |
| Anxiety | 32 ( 8%) | 80 ( 5%) | 118 ( 6%) | 98 ( 6%) |
| Depression | 33 ( 8%) | 63 ( 4%) | 102 ( 5%) | 87 ( 5%) |
| Dizziness | 15 ( 4%) | 49 ( 3%) | 67 ( 3%) | 44 ( 3% |
| Dry mouth | 13 ( 3%) | 23 ( 1%) | 36 ( 2%) | 28 ( 2%) |
| Insomnia | 34 ( 9%) | 94 ( 6%) | 137 ( 7%) | 121 ( 7%) |
| Paresthesia | 11 ( 3%) | 29 ( 2%) | 40 ( 2%) | 34 ( 2%) |
| Skin and Appendages | 26 ( 7%) | 150 (10%) | 187 ( 9%) | 169 (10%) |
| Pruritus | 12 ( 3%) | 68 ( 4%) | 82 ( 4%) | 58 ( 3%) |
| Sweating | 11 ( 3%) | 27 ( 2%) | 40 ( 2%) | 39 ( 2%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Somerset Therapeutics, LLC, effective July 14, 2026 (SPL set 1cfe4675-766f-4f1a-b1a8-96bbdacfcfa5), via openFDA; the full label on DailyMed
What do FAERS reports show?
322 reports list acamprosate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 37 are coded as a death and 148 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Acamprosate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions