Drug Safety Information for AMOXAPINE (Amoxapine)

Adverse Drug Reactions for AMOXAPINE* (Amoxapine)

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 AMOXAPINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pyrexia27
2Completed suicide27
3Toxicity to various agents23
4Depression21
5Drug ineffective21
6Overdose19
7Somnolence16
8Drug interaction16
9Hepatic function abnormal15
10Convulsion14
11Decreased appetite14
12Suicide attempt14
13Aspartate aminotransferase increased13
14Insomnia13
15Anxiety13
16Malaise13
17Alanine aminotransferase increased13
18Blood creatine phosphokinase increased12
19Serotonin syndrome12
20Dyspnoea12

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

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

Reason # of FDA Reports
1Depression*418
2Product used for unknown indication114
3Major depression41
4Suicide attempt34
5Bipolar disorder20
6Panic disorder15
7Bipolar i disorder15
8Antidepressant therapy14
9Intentional overdose11
10Neuralgia11

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


Types of Adverse Events for AMOXAPINE

Total Reports Filed with FDA: 1909


Number of FDA Adverse Event Reports by Patient Age for AMOXAPINE

Total Reports Filed with FDA: 1909*


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

Charts are based on 1909 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 AMOXAPINE 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.