Drug Safety Information for FANAPT (Iloperidone)

Safety-related Labeling Changes for FANAPT (ILOPERIDONE) Rx Drug: FDA Link

Required post-approval safety study:

A deferred pediatric study under PREA for the treatment of schizophrenia in pediatric patients ages 13 to 17. A study of the efficacy and safety of iloperidone tablets in the relevant pediatric population. Due Date: 2020-09-25

Original FDA Drug Approval Date for FANAPT: 2009-05-06

Adverse Drug Reactions for FANAPT* (Iloperidone)

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 FANAPT
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Dizziness	64
2	Weight increased	48
3	Drug ineffective	35
4	Insomnia*	33
5	Dyspnoea	31
6	Nausea	31
7	Tachycardia	29
8	Oedema peripheral	28
9	Orthostatic hypotension	27
10	Priapism	25
11	Vomiting	24
12	Somnolence	24
13	Dry mouth	22
14	Loss of consciousness	21
15	Heart rate increased	21
16	Headache	21
17	Anxiety	20
18	Palpitations	20
19	Fatigue*	20
20	Death	20

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

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

	Reason	# of FDA Reports
1	Schizophrenia*	438
2	Bipolar disorder*	153
3	Product used for unknown indication	114
4	Schizoaffective disorder	76
5	Psychotic disorder	66
6	Paranoia	33
7	Affective disorder	29
8	Mental disorder	27
9	Major depression	23
10	Convulsion	23

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

Types of Adverse Events for FANAPT

Total Reports Filed with FDA: 2157

Number of FDA Adverse Event Reports by Patient Age for FANAPT

Total Reports Filed with FDA: 2157*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Iloperidone (Fanapt)

Charts are based on 2157 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.