Drug Safety Information for HALOPERIDOL DECANOATE (Haloperidol decanoate)

Adverse Drug Reactions for HALOPERIDOL DECANOATE* (Haloperidol decanoate)

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 HALOPERIDOL DECANOATE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Weight increased158
2Extrapyramidal disorder105
3Neuroleptic malignant syndrome43
4Psychotic disorder30
5Drug ineffective29
8Diabetes mellitus26
10Medication error25
12Drug interaction23
13Tardive dyskinesia22
15Treatment noncompliance21
19Pulmonary embolism18

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

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

Reason # of FDA Reports
1Product used for unknown indication545
3Schizophrenia, paranoid type219
4Psychotic disorder158
5Schizoaffective disorder111
6Bipolar disorder55
8Bipolar i disorder27
10Tourette's disorder21

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

Types of Adverse Events for HALOPERIDOL DECANOATE

Total Reports Filed with FDA: 2827

Number of FDA Adverse Event Reports by Patient Age for HALOPERIDOL DECANOATE

Total Reports Filed with FDA: 2827*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Haloperidol decanoate (Haldol decanoate)

Charts are based on 2827 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 HALOPERIDOL DECANOATE 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.

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