Drug Safety Information for LATUDA (Lurasidone hydrochloride)

Safety-related Labeling Changes for LATUDA ( LURASIDONE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for LATUDA* (Lurasidone 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 LATUDA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Drug ineffective	75
2	Weight increased	68
3	Insomnia	65
4	Off label use	63
5	Depression	60
6	Suicidal ideation	57
7	Nausea	57
8	Tremor	56
9	Agitation	54
10	Dyspnoea	54
11	Psychotic disorder	53
12	Anxiety	52
13	Rash	51
14	Vomiting	49
15	Fall	47
16	Feeling abnormal	46
17	Aggression	45
18	Dizziness	45
19	Fatigue	43
20	Confusional state	41

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	761
2	Bipolar disorder	742
3	Schizophrenia	492
4	Depression	394
5	Bipolar i disorder	392
6	Schizoaffective disorder	224
7	Bipolar ii disorder	122
8	Anxiety	113
9	Psychotic disorder	112
10	Schizophrenia, paranoid type	111

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

Types of Adverse Events for LATUDA

Total Reports Filed with FDA: 5395

Number of FDA Adverse Event Reports by Patient Age for LATUDA

Total Reports Filed with FDA: 5395*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Lurasidone hydrochloride (Latuda)

Charts are based on 5395 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.