Drug Safety Information for VRAYLAR (Cariprazine hydrochloride)

FDA Safety-related Labeling Changes for VRAYLAR (CARIPRAZINE HYDROCHLORIDE) Rx Drug: Safety Information Link

Required post-approval safety study:

Deferred pediatric study under PREA (ages 10 to 17 years) with a diagnosis of schizophrenia or bipolar I disorder to obtain pharmacokinetic, safety, and tolerability data to inform the selection of doses in efficacy and safety studies in pediatric patients with schizophrenia and bipolar I disorder. Due Date: 2020-03-31

Required post-approval safety study:

Deferred long-term, open-label safety study in pediatric patients with schizophrenia (ages 13 to 17) and bipolar I disorder, recent manic episodes (ages 10 to 17). Due Date: 2025-06-30

Required post-approval safety study:

Deferred long-term, open-label safety study in pediatric patients with schizophrenia (ages 13 to 17) and bipolar I disorder, recent manic episodes (ages 10 to 17). Due Date: 2025-06-30

Required post-approval safety study:

Deferred pediatric study under PREA for the treatment of bipolar I disorder, manic episodes in patients aged 10 to 17. A study of the efficacy and safety of cariprazine in the relevant population. Due Date: 2023-03-31

Required post-approval safety study:

Deferred pediatric study under PREA for the treatment of schizophrenia in patients aged 13 to 17. A study of the efficacy and safety of cariprazine in the relevant pediatric population. Due Date: 2023-05-31

Required post-approval safety study:

Original FDA Drug Approval Date for VRAYLAR: 2015-09-17

Adverse Drug Reactions for VRAYLAR* (Cariprazine 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 VRAYLAR
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Suicide attempt	2
2	Intentional overdose	2

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

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

	Reason	# of FDA Reports
1	Bipolar i disorder	2
2	Bipolar disorder	2

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

Types of Adverse Events for VRAYLAR

Total Reports Filed with FDA: 4

Number of FDA Adverse Event Reports by Patient Age for VRAYLAR

Total Reports Filed with FDA: 4*

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

Charts are based on 4 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.