Drug Safety Information for LOXITANE (Loxapine succinate)

FDA Safety-related Labeling Changes for LOXITANE (LOXAPINE SUCCINATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for LOXITANE* (Loxapine succinate)

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 LOXITANE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diabetes mellitus50
2Weight increased49
3Overdose42
4Type 2 diabetes mellitus41
5Agitation34
6Confusional state33
7Neuroleptic malignant syndrome33
8Pyrexia33
9Hypertension31
10Psychotic disorder30
11Depression29
12Death29
13Fall25
14Somnolence25
15Nausea24
16Convulsion23
17Toxicity to various agents23
18Asthenia23
19Dyspnoea22
20Tremor21

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

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

Reason # of FDA Reports
1Product used for unknown indication525
2Psychotic disorder124
3Schizophrenia75
4Bipolar disorder*67
5Agitation50
6Ill-defined disorder37
7Aggression29
8Bipolar i disorder29
9Mental disorder28
10Abnormal behaviour24

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


Types of Adverse Events for LOXITANE

Total Reports Filed with FDA: 3820


Number of FDA Adverse Event Reports by Patient Age for LOXITANE

Total Reports Filed with FDA: 3820*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Loxapine succinate (Loxapine, Loxapine succinate, Loxitane)

Charts are based on 3820 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.

Click to go back to search results and LOXITANE Reviews and Review Summary .

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.