Common Side Effects of Acamprosate
The most common side effects of acamprosate are gastrointestinal symptoms (particularly diarrhea), along with headache, pruritus (itching), and sweating. 1
Primary Side Effects from FDA Labeling
According to the FDA drug label, adverse events occurring at ≥3% frequency and greater than placebo include 1:
Gastrointestinal:
- Diarrhea (most common, leading to discontinuation in 2% of patients vs 0.7% with placebo)
- Flatulence
- Nausea
- Anorexia
Neuropsychiatric:
- Anxiety
- Depression
- Dizziness
- Insomnia
- Dry mouth
- Paresthesia
Dermatologic:
- Pruritus
- Sweating
General:
- Accidental injury
- Asthenia (weakness)
- Pain
Important Safety Considerations
Tolerability Profile
The overall discontinuation rate due to adverse events is relatively low (8% vs 6% with placebo in short-term studies), indicating acamprosate is generally well-tolerated 1. Most side effects are mild and transient, particularly gastrointestinal symptoms 2, 3.
Critical Warnings to Monitor
Suicidality and Depression: While infrequent, suicidal ideation and attempts occurred more commonly with acamprosate (1.4% vs 0.5% in short studies; 2.4% vs 0.8% in year-long studies) 1. Monitor all patients for emerging depression or suicidal thinking, and educate families/caregivers to report such symptoms immediately.
Renal Considerations: Acamprosate requires dose reduction in moderate renal impairment and is contraindicated in severe renal impairment 1.
Rare but Reported Adverse Effects
While not common, case reports have documented:
- Extrapyramidal symptoms in elderly patients (resolved within one week of discontinuation) 4
- Syncope in elderly patients, though causality remains uncertain 5
Clinical Context
The side effect profile of acamprosate compares favorably to other AUD medications. Recent evidence suggests acamprosate may be safer than baclofen in cirrhotic patients, with fewer unplanned hospital admissions 6. The drug has demonstrated good safety even in patients with alcohol-associated liver disease 7.