Drug Safety Information for INVEGA (Paliperidone)

FDA Safety-related Labeling Changes for INVEGA (PALIPERIDONE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for INVEGA SUSTENNA (PALIPERIDONE PALMITATE) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for INVEGA TRINZA (PALIPERIDONE PALMITATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for INVEGA* (Paliperidone)

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 INVEGA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Gynaecomastia	2039
2	Hyperprolactinaemia	1970
3	Abnormal weight gain	1917
4	Galactorrhoea	1664
5	Weight increased*	397
6	Drug ineffective	297
7	Psychotic disorder	233
8	Blood prolactin increased	200
9	Anxiety*	191
10	Depression*	179
11	Insomnia	177
12	Dizziness	171
13	Somnolence*	169
14	Tremor	169
15	Extrapyramidal disorder	165
16	Fatigue*	153
17	Schizophrenia	150
18	Suicidal ideation	145
19	Aggression	144
20	Akathisia	143

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

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

	Reason	# of FDA Reports
1	Product used for unknown indication	12233
2	Schizophrenia*	4134
3	Bipolar disorder*	1196
4	Schizoaffective disorder*	807
5	Psychotic disorder*	692
6	Schizophrenia, paranoid type*	611
7	Depression	302
8	Bipolar i disorder*	279
9	Affective disorder	120
10	Mental disorder	102

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

Types of Adverse Events for INVEGA

Total Reports Filed with FDA: 25298

Number of FDA Adverse Event Reports by Patient Age for INVEGA

Total Reports Filed with FDA: 25298*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Paliperidone (Invega, Paliperidone)

Charts are based on 25298 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.