Drug Safety Information for PAXIL (Paroxetine hydrochloride)

Safety-related Labeling Changes for PAXIL (PAROXETINE HYDROCHLORIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for PAXIL CR (PAROXETINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for PAXIL* (Paroxetine 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 PAXIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug withdrawal syndrome6260
2Nausea*4326
3Dizziness*4256
4Anxiety4043
5Drug ineffective3884
6Depression3327
7Fatigue*3136
8Headache*3136
9Insomnia*2789
10Suicidal ideation2612
11Tremor2304
12Diarrhoea2196
13Weight increased*2189
14Paraesthesia2149
15Vomiting2120
16Asthenia1965
17Hyperhidrosis1925
18Confusional state1899
19Pain1885
20Dyspnoea1832

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

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

Reason # of FDA Reports
1Depression*64072
2Product used for unknown indication47665
3Anxiety*13321
4Panic disorder*3780
5Obsessive-compulsive disorder*2318
6Ill-defined disorder2057
7Panic attack*2047
8Major depression1689
9Anxiety disorder*1470
10Bipolar disorder1375

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


Types of Adverse Events for PAXIL

Total Reports Filed with FDA: 299359


Number of FDA Adverse Event Reports by Patient Age for PAXIL

Total Reports Filed with FDA: 299359*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Paroxetine hydrochloride (Paroxetina, Paroxetine, Paxilcr, Paxil cr, Paxil)

Charts are based on 299359 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 PAXIL 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.