Drug Safety Information for ORAP (Pimozide)

Adverse Drug Reactions for ORAP* (Pimozide)

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 ORAP
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Weight increased	43
2	Drug interaction	27
3	Electrocardiogram qt prolonged	27
4	Anxiety*	26
5	Drug ineffective	25
6	Somnolence	22
7	Tremor	21
8	Neuroleptic malignant syndrome	17
9	Dyskinesia	17
10	Suicidal ideation*	17
11	Suicide attempt	16
12	Overdose	16
13	Blood creatine phosphokinase increased	15
14	Vomiting	15
15	Tic	14
16	Fatigue	14
17	Musculoskeletal stiffness	14
18	Depression	14
19	Dystonia	13
20	Diarrhoea	13

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	241
2	Tourette's disorder	175
3	Schizophrenia	76
4	Psychotic disorder	57
5	Depression	43
6	Bladder disorder	34
7	Anxiety	30
8	Tic*	21
9	Dyskinesia	20
10	Autism	20

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

Types of Adverse Events for ORAP

Total Reports Filed with FDA: 1944

Number of FDA Adverse Event Reports by Patient Age for ORAP

Total Reports Filed with FDA: 1944*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pimozide (Orap forte, Orap, Pimozide)

Charts are based on 1944 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.

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.