Drug Safety Information for BELVIQ (Lorcaserin hydrochloride)

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

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

FDA Safety-related Labeling Changes for BELVIQ (LORCASERIN HYDROCHLORIDE) Rx Drug: Safety Information 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
1	Headache	339
2	Fatigue	308
3	Drug ineffective	269
4	Dizziness	240
5	Nausea	150
6	Weight increased	106
7	Somnolence	84
8	Dry mouth	68
9	Drug effect decreased	64
10	Constipation	63
11	Feeling abnormal	61
12	Back pain	53
13	Insomnia	47
14	Chills	40
15	Cough	37
16	Arthralgia	36
17	Diarrhoea	36
18	Palpitations	30
19	Hunger	30
20	Migraine	30

* 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
1	Weight decreased	2530
2	Weight control	440
3	Product used for unknown indication	383
4	Obesity	139
5	Weight increased	29
6	Weight loss diet	24
7	Overweight	15
8	Decreased appetite	10
9	Appetite disorder	10
10	Depression	9

*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.

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.