Drug Safety Information for ZOLOFT (Sertraline hydrochloride)

Safety-related Labeling Changes for ZOLOFT (SERTRALINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for ZOLOFT* (Sertraline 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 ZOLOFT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*4432
2Drug ineffective4409
3Depression4049
4Anxiety4018
5Fatigue3732
6Headache*3481
7Pain3299
8Dizziness*3164
9Insomnia*2972
10Diarrhoea*2902
11Dyspnoea2859
12Vomiting2651
13Asthenia2578
14Fall2408
15Feeling abnormal2031
16Malaise2030
17Tremor2011
18Weight increased*1929
19Suicidal ideation1840
20Weight decreased1793

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

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

Reason # of FDA Reports
1Depression*76141
2Product used for unknown indication31470
3Anxiety*10600
4Ill-defined disorder3196
5Obsessive-compulsive disorder*3171
6Major depression*1845
7Bipolar disorder*1753
8Panic attack*1342
9Antidepressant therapy1256
10Post-traumatic stress disorder1245

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


Types of Adverse Events for ZOLOFT

Total Reports Filed with FDA: 353457


Number of FDA Adverse Event Reports by Patient Age for ZOLOFT

Total Reports Filed with FDA: 353457*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Sertraline hydrochloride (Lustral, Apo-sertraline, Besitran, Aremis, Gladem, Novo-sertraline, Sertraline, Ratio-sertraline, Sertralina, Altruline, Zoloft)

Charts are based on 353457 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 ZOLOFT 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.