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 | |
---|---|---|
1 | Drug withdrawal syndrome | 6260 |
2 | Nausea* | 4326 |
3 | Dizziness* | 4256 |
4 | Anxiety | 4043 |
5 | Drug ineffective | 3884 |
6 | Depression | 3327 |
7 | Fatigue* | 3136 |
8 | Headache* | 3136 |
9 | Insomnia* | 2789 |
10 | Suicidal ideation | 2612 |
11 | Tremor | 2304 |
12 | Diarrhoea | 2196 |
13 | Weight increased* | 2189 |
14 | Paraesthesia | 2149 |
15 | Vomiting | 2120 |
16 | Asthenia | 1965 |
17 | Hyperhidrosis | 1925 |
18 | Confusional state | 1899 |
19 | Pain | 1885 |
20 | Dyspnoea | 1832 |
* 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 | |
---|---|---|
1 | Depression* | 64072 |
2 | Product used for unknown indication | 47665 |
3 | Anxiety* | 13321 |
4 | Panic disorder* | 3780 |
5 | Obsessive-compulsive disorder* | 2318 |
6 | Ill-defined disorder | 2057 |
7 | Panic attack* | 2047 |
8 | Major depression | 1689 |
9 | Anxiety disorder* | 1470 |
10 | Bipolar disorder | 1375 |
*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.
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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.