Drug Safety Information for SERENTIL (Mesoridazine besylate)

Adverse Drug Reactions for SERENTIL* (Mesoridazine besylate)

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 SERENTIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Insomnia6
2Gait disturbance4
3Diabetes mellitus4
4Abdominal pain upper4
5Constipation3
6Paranoia3
7Weight decreased3
8Agitation3
9Psychomotor hyperactivity3
10Type 2 diabetes mellitus3
11Electrocardiogram abnormal3
12Fall3
13Tardive dyskinesia3
14Lower respiratory tract infection2
15Arthralgia2
16Ascites2
17Rhinorrhoea2
18Drug dependence2
19Aggression2
20Gastrooesophageal reflux disease2

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

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

Reason # of FDA Reports
1Hallucination31
2Schizophrenia21
3Psychotic disorder20
4Mental disorder13
5Anxiety7
6Schizoaffective disorder5
7Dementia5
8Depression1
9Product used for unknown indication1

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


Types of Adverse Events for SERENTIL

Total Reports Filed with FDA: 248


Number of FDA Adverse Event Reports by Patient Age for SERENTIL

Total Reports Filed with FDA: 248*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Mesoridazine besylate (Serentil)

Charts are based on 248 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 SERENTIL 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 SERENTIL's side effects.