Drug Safety Information for SAPHRIS (Asenapine)

Safety-related Labeling Changes for SAPHRIS (ASENAPINE MALEATE) Rx Drug: FDA Link

Adverse Drug Reactions for SAPHRIS* (Asenapine)

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 SAPHRIS
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Inappropriate schedule of drug administration	559
2	Underdose	349
3	Dysgeusia*	328
4	Weight increased*	320
5	Hypoaesthesia oral	293
6	Dizziness	235
7	Somnolence*	234
8	Akathisia*	214
9	Incorrect route of drug administration	210
10	Nausea	205
11	Insomnia	189
12	Sedation	177
13	Anxiety*	154
14	Swollen tongue	146
15	Feeling abnormal	141
16	Vomiting	137
17	Dyspnoea	132
18	Agitation*	131
19	Oedema peripheral	124
20	Drug ineffective	123

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

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

	Reason	# of FDA Reports
1	Bipolar disorder*	3557
2	Product used for unknown indication	3244
3	Schizophrenia*	1353
4	Bipolar i disorder	807
5	Depression*	439
6	Schizoaffective disorder*	293
7	Psychotic disorder	292
8	Affective disorder	178
9	Insomnia	121
10	Bipolar ii disorder	91

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

Types of Adverse Events for SAPHRIS

Total Reports Filed with FDA: 14061

Number of FDA Adverse Event Reports by Patient Age for SAPHRIS

Total Reports Filed with FDA: 14061*

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

Charts are based on 14061 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.