Drug Safety Information for STELAZINE (Trifluoperazine hydrochloride)

Adverse Drug Reactions for STELAZINE* (Trifluoperazine 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 STELAZINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diabetes mellitus156
2Type 2 diabetes mellitus125
3Tardive dyskinesia55
4Depression52
5Blood cholesterol increased51
6Weight increased*49
7Insomnia48
8Obesity46
9Anxiety46
10Hyperglycaemia40
11Completed suicide39
12Headache39
13Pancreatitis38
14Hypertension37
15Diabetes mellitus inadequate control37
16Nausea34
17Hyperlipidaemia34
18Somnolence*33
19Fatigue33
20Dizziness*33

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

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

Reason # of FDA Reports
1Product used for unknown indication232
2Schizophrenia*217
3Psychotic disorder85
4Depression78
5Bipolar disorder*77
6Anxiety*52
7Fibromyalgia35
8Mania32
9Schizoaffective disorder29
10Paranoia27

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


Types of Adverse Events for STELAZINE

Total Reports Filed with FDA: 5027


Number of FDA Adverse Event Reports by Patient Age for STELAZINE

Total Reports Filed with FDA: 5027*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Trifluoperazine hydrochloride (Trifluoperazina, Trifluoperazine, Eskazine, Stelazine, Trifluoperazine hcl)

Charts are based on 5027 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 STELAZINE Reviews and Review Summary .

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.

Visit   DrugInformer.com more on STELAZINE's side effects.