Safety
Linaclotide
Adverse-event report summary for Linaclotide, drawn from the FDA Adverse Event Reporting System (FAERS).
- Total reports
- 2,794
- Reports flagged serious
- 1,561
“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
- Diarrhoea599 reports
- Off Label Use302 reports
- Drug Ineffective270 reports
- Constipation205 reports
- Abdominal Pain179 reports
- Nausea148 reports
- Abdominal Distension122 reports
- Headache120 reports
- Completed Suicide102 reports
- Dizziness92 reports
- Fatigue90 reports
- Abdominal Pain Upper89 reports
- Pain88 reports
- Flatulence86 reports
- Malaise71 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.