Safety
Linaclotide
Adverse-event report summary for Linaclotide, drawn from the FDA Adverse Event Reporting System (FAERS).
- Total reports
- 2,877
- Reports flagged serious
- 1,599
“Serious” is FAERS’s own report-level flag (e.g. death, hospitalization, or another outcome the reporter marked as serious) and does not indicate a verified or compound-caused outcome.
Most frequently reported reactions
- Diarrhoea609 reports
- Off Label Use316 reports
- Drug Ineffective286 reports
- Constipation215 reports
- Abdominal Pain182 reports
- Nausea153 reports
- Abdominal Distension123 reports
- Headache123 reports
- Completed Suicide103 reports
- Dizziness97 reports
- Pain95 reports
- Fatigue91 reports
- Abdominal Pain Upper90 reports
- Flatulence87 reports
- Malaise75 reports
Counts reflect the most-reported reaction terms (MedDRA preferred terms) associated with reports naming this compound. A single report can list multiple reactions, so reaction counts need not sum to the total number of reports.