Drug Safety Information for PRISTIQ (Desvenlafaxine succinate)

Safety-related Labeling Changes for PRISTIQ (DESVENLAFAXINE SUCCINATE) Rx Drug: FDA Link

Adverse Drug Reactions for PRISTIQ* (Desvenlafaxine succinate)

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 PRISTIQ
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*1641
2Drug ineffective1425
3Headache*1299
4Dizziness*1293
5Insomnia*1115
6Anxiety*1060
7Drug withdrawal syndrome1004
8Fatigue*959
9Feeling abnormal937
10Depression790
11Malaise607
12Diarrhoea586
13Condition aggravated568
14Hyperhidrosis548
15Medication residue535
16Somnolence*481
17Pain459
18Tremor446
19Suicidal ideation428
20Crying424

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

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

Reason # of FDA Reports
1Depression*24021
2Anxiety*1894
3Major depression*1706
4Product used for unknown indication1666
5Bipolar disorder*284
6Antidepressant therapy272
7Obsessive-compulsive disorder*229
8Fibromyalgia*209
9Post-traumatic stress disorder207
10Hot flush*172

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


Types of Adverse Events for PRISTIQ

Total Reports Filed with FDA: 50750


Number of FDA Adverse Event Reports by Patient Age for PRISTIQ

Total Reports Filed with FDA: 50750*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Desvenlafaxine succinate (Pristiq)

Charts are based on 50750 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 PRISTIQ 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.