Drug Safety Information for XENICAL (Orlistat)

Safety-related Labeling Changes for XENICAL (ORLISTAT) Rx Drug: FDA Link

Safety-related Labeling Changes for ALLI (ORLISTAT) Over-the-counter Drug: FDA Link

Adverse Drug Reactions for XENICAL* (Orlistat)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with XENICAL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective2572
2Rectal discharge2119
3Gastrointestinal disorder2097
4Constipation*1825
5Weight increased*1695
6Diarrhoea*1519
7Flatulence*1428
8Steatorrhoea1183
9Abdominal pain upper1121
10Headache*944
11Abdominal distension*926
12Product quality issue899
13Nausea789
14Malaise651
15Abdominal pain579
16Frequent bowel movements559
17Dizziness528
18Treatment noncompliance513
19Vomiting446
20Fatigue441

* This side effect also appears in "Top 10 Side Effects of XENICAL " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking XENICAL
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication11798
2Weight loss diet4713
3Weight decreased*4419
4Obesity*3373
5Weight control1439
6Overweight*386
7Weight increased*84
8Constipation72
9Gastrointestinal disorder43
10Change of bowel habit29

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for XENICAL

Total Reports Filed with FDA: 51534


Number of FDA Adverse Event Reports by Patient Age for XENICAL

Total Reports Filed with FDA: 51534*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Orlistat (Alli, Xenical)

Charts are based on 51534 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and XENICAL Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.