Drug Safety Information for SERZONE (Nefazodone hydrochloride)

Adverse Drug Reactions for SERZONE* (Nefazodone hydrochloride)

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 SERZONE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Depression192
2Hepatocellular injury188
3Nausea*184
4Diabetes mellitus171
5Fatigue*160
6Anxiety158
7Dizziness*146
8Type 2 diabetes mellitus139
9Insomnia*133
10Drug ineffective*132
11Headache*126
12Pain110
13Weight increased109
14Weight decreased97
15Chest pain96
16Suicidal ideation92
17Alanine aminotransferase increased89
18Diarrhoea89
19Dyspnoea88
20Asthenia85

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

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

Reason # of FDA Reports
1Depression*2934
2Product used for unknown indication599
3Anxiety*158
4Antidepressant therapy60
5Fibromyalgia58
6Post-traumatic stress disorder53
7Headache38
8Migraine38
9Major depression*36
10Panic attack27

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


Types of Adverse Events for SERZONE

Total Reports Filed with FDA: 14978


Number of FDA Adverse Event Reports by Patient Age for SERZONE

Total Reports Filed with FDA: 14978*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nefazodone hydrochloride (Nefazodone, Dutonin, Nefadar, Serzone)

Charts are based on 14978 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 SERZONE 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.