Drug Safety Information for GEODON (Ziprasidone mesylate)

FDA Safety-related Labeling Changes for GEODON (ZIPRASIDONE HYDROCHLORIDE) Rx Drug: Safety Information Link

Required post-approval safety study:

You are required to assess the safety and effectiveness of Geodon as a treatment for bipolar disorder in pediatric patients ages 10 to 17 (children and adolescents). Final Report Submission: February 11, 2008 Due Date: 2020-12-31

Original FDA Drug Approval Date for GEODON: 2001-02-05

Adverse Drug Reactions for GEODON* (Ziprasidone mesylate)

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 GEODON
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Diabetes mellitus	1054
2	Type 2 diabetes mellitus	884
3	Weight increased*	823
4	Drug ineffective	693
5	Anxiety*	620
6	Tardive dyskinesia	593
7	Somnolence*	585
8	Depression	570
9	Insomnia*	555
10	Tremor*	541
11	Nausea*	493
12	Feeling abnormal	445
13	Dizziness*	424
14	Fatigue*	420
15	Blood cholesterol increased	404
16	Suicidal ideation	400
17	Dyspnoea	388
18	Agitation	386
19	Completed suicide	383
20	Headache	377

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

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

	Reason	# of FDA Reports
1	Bipolar disorder*	5061
2	Schizophrenia*	3134
3	Product used for unknown indication	2363
4	Depression*	2177
5	Psychotic disorder	1806
6	Ill-defined disorder	1301
7	Schizoaffective disorder*	1292
8	Bipolar i disorder*	789
9	Affective disorder	622
10	Agitation	503

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

Types of Adverse Events for GEODON

Total Reports Filed with FDA: 55798

Number of FDA Adverse Event Reports by Patient Age for GEODON

Total Reports Filed with FDA: 55798*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ziprasidone mesylate (Ziprasidone, Geodon)

Charts are based on 55798 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.