Drug Safety Information for PEXEVA (Paroxetine mesylate)

FDA Safety-related Labeling Changes for PEXEVA (PAROXETINE MESYLATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for BRISDELLE (PAROXETINE MESYLATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for PEXEVA* (Paroxetine mesylate)

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 PEXEVA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective	94
2	Nausea	52
3	Headache	49
4	Dizziness*	41
5	Insomnia	40
6	Hot flush	34
7	Fatigue*	32
8	Drug dose omission	27
9	Weight increased*	23
10	Somnolence	19
11	Diarrhoea	17
12	Anxiety	17
13	Drug prescribing error	17
14	Vomiting	16
15	Drug administration error	15
16	Product quality issue	14
17	Off label use	14
18	Feeling abnormal	13
19	Hyperhidrosis	13
20	Suicidal ideation	12

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

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

	Reason	# of FDA Reports
1	Hot flush	576
2	Product used for unknown indication	186
3	Depression	143
4	Fatigue	38
5	Anxiety	25
6	Panic attack	20
7	Menopausal symptoms	19
8	Menopause	13
9	Obsessive-compulsive disorder	11
10	Obsessive-compulsive personality disorder	10

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

Types of Adverse Events for PEXEVA

Total Reports Filed with FDA: 1373

Number of FDA Adverse Event Reports by Patient Age for PEXEVA

Total Reports Filed with FDA: 1373*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Paroxetine mesylate (Pexeva, Brisdelle)

Charts are based on 1373 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.