Drug Safety Information for MERIDIA (Sibutramine hydrochloride)

Adverse Drug Reactions for MERIDIA* (Sibutramine hydrochloride)

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 MERIDIA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective150
2Headache*133
3Dizziness*103
4Nausea102
5Dyspnoea101
6Insomnia*89
7Palpitations88
8Weight increased*77
9Anxiety*76
10Blood pressure increased75
11Fatigue72
12Depression*70
13Chest pain70
14Hypertension66
15Asthenia59
16Weight loss poor58
17Drug interaction53
18Pain52
19Abortion induced52
20Vomiting50

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

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

Reason # of FDA Reports
1Obesity*1553
2Product used for unknown indication1289
3Weight control1212
4Weight decreased*836
5Overweight*198
6Maternal exposure during pregnancy109
7Weight84
8Decreased appetite38
9Depression35
10Medical diet28

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


Types of Adverse Events for MERIDIA

Total Reports Filed with FDA: 7946


Number of FDA Adverse Event Reports by Patient Age for MERIDIA

Total Reports Filed with FDA: 7946*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Sibutramine hydrochloride (Sibutramine, Meridia, Reductil)

Charts are based on 7946 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 MERIDIA 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.