Drug Safety Information for BELVIQ (Lorcaserin hydrochloride)

FDA Safety Communication for BELVIQ (LORCASERIN HYDROCHLORIDE) Rx Drug: FDA Link

Potential risk of cancer outweighs the benefits FDA requests the withdrawal of the weight-loss drug

Safety-related Labeling Changes for BELVIQ (LORCASERIN HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for BELVIQ* (Lorcaserin 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 BELVIQ
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Headache339
2Fatigue308
3Drug ineffective269
4Dizziness240
5Nausea150
6Weight increased106
7Somnolence84
8Dry mouth68
9Drug effect decreased64
10Constipation63
11Feeling abnormal61
12Back pain53
13Insomnia47
14Chills40
15Cough37
16Arthralgia36
17Diarrhoea36
18Palpitations30
19Hunger30
20Migraine30

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

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

Reason # of FDA Reports
1Weight decreased2530
2Weight control440
3Product used for unknown indication383
4Obesity139
5Weight increased29
6Weight loss diet24
7Overweight15
8Decreased appetite10
9Appetite disorder10
10Depression9

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


Types of Adverse Events for BELVIQ

Total Reports Filed with FDA: 3875


Number of FDA Adverse Event Reports by Patient Age for BELVIQ

Total Reports Filed with FDA: 3875*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Lorcaserin hydrochloride (Belviq)

Charts are based on 3875 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 BELVIQ Reviews and Review Summary .

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.

Visit   DrugInformer.com more on BELVIQ's side effects.