Drug Safety Information for FLUVOXAMINE MALEATE (Fluvoxamine maleate)

Safety-related Labeling Changes for LUVOX CR (FLUVOXAMINE MALEATE) Rx Drug: FDA Link

Adverse Drug Reactions for FLUVOXAMINE MALEATE* (Fluvoxamine maleate)

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 FLUVOXAMINE MALEATE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug interaction289
6Drug ineffective155
13Serotonin syndrome130
14Toxicity to various agents125
16Suicidal ideation118
19Completed suicide110
20Condition aggravated105

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

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

Reason # of FDA Reports
2Product used for unknown indication1601
3Obsessive-compulsive disorder*1446
5Bipolar disorder174
6Social phobia134
8Maternal exposure during pregnancy123
9Ill-defined disorder110
10Major depression110

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

Types of Adverse Events for FLUVOXAMINE MALEATE

Total Reports Filed with FDA: 17879

Number of FDA Adverse Event Reports by Patient Age for FLUVOXAMINE MALEATE

Total Reports Filed with FDA: 17879*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Fluvoxamine maleate (Fluvoxamine, Fevarin, Fluoxamine, Floxyfral, Luvox cr, Dumirox, Fluvoxamine maleate, Luvox)

Charts are based on 17879 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.

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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.

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