Adverse events (AEs) of orlistat
| Authors | Number of subjects | Duration (months) | Serious AEs | Serious AEs assessed as possibly related to drug | |
|---|---|---|---|---|---|
| Derosa et al. (2010)13 | 258 | 12 | Malaise | ||
| Fatty evacuation | |||||
| Perrio et al. (2007)10 | 16,021 (orlistat) | Prescription-event monitoring | Ten most frequently reported reasons for stopping medication: diarrhea, intolerance, weight gain, unspecified side effects, abdominal pain, flatulence, unspecified gastrointestinal symptom, fecal incontinence, pregnancy, headache | 18 deaths due to cardiovascular or cerebrovascular events | Elevated liver function test (2) |
| Hypertension (3) | |||||
| Pedal edema (1) | |||||
| Swollen ankle (3) | |||||
| Lichen planus of the tongue (1) | |||||
| Chanoine et al. (2005)14 | 539 adolescents | 12 | Fatty stool | Pilonidal abscess (1) | Symptomatic cholelithiasis that led to cholecystectomy |
| Oily spotting | Depression (2) | ||||
| Oily evacuation | Asthma attack (1) seizure (1) | ||||
| Abdominal pain | Admission for repair of deviated nasal septum (1) | ||||
| Fecal urgency | Appendicitis (1) | ||||
| Flatus with discharge | Cholelithiasis (1) | ||||
| Soft stool | Gallbladder disorder followed by cholecystectomy (1) | ||||
| Increased defecation | Adenoidal hypertrophy (1) | ||||
| Flatulence | Aseptic meningitis (1) | ||||
| Fecal incontinence | |||||
| Sj?str?m et al. (1998)7 | 743 | 24 | Fatty stool | (25) | (1) |
| Increased defecation | |||||
| Oily spotting | |||||
| Soft stool | |||||
| Liquid stools | |||||
| Abdominal pain | |||||
| Fecal urgency | |||||
| Flatulence | |||||
| Flatus with discharge | |||||
| Fecal incontinence | |||||
| Oily evacuation |
Occurred at a rate of ≥5%, except Perrio et al.