Drug Safety Information for DOXEPIN HYDROCHLORIDE (Doxepin hydrochloride)

Safety-related Labeling Changes for SILENOR (DOXEPIN HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for DOXEPIN HYDROCHLORIDE* (Doxepin 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 DOXEPIN HYDROCHLORIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Completed suicide456
2Toxicity to various agents366
3Nausea340
4Drug ineffective*300
5Fatigue*286
6Pain273
7Death263
8Dizziness253
9Depression252
10Dyspnoea246
11Insomnia238
12Headache233
13Drug abuse226
14Anxiety216
15Fall215
16Vomiting213
17Diarrhoea212
18Overdose203
19Somnolence*190
20Hypertension184

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

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

Reason # of FDA Reports
1Product used for unknown indication3460
2Depression*2243
3Insomnia*801
4Sleep disorder519
5Pruritus*323
6Anxiety*220
7Ill-defined disorder211
8Migraine prophylaxis190
9Pain129
10Urticaria*82

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


Types of Adverse Events for DOXEPIN HYDROCHLORIDE

Total Reports Filed with FDA: 31372


Number of FDA Adverse Event Reports by Patient Age for DOXEPIN HYDROCHLORIDE

Total Reports Filed with FDA: 31372*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Doxepin hydrochloride (Deptran, Doxepin beta, Doxepin dura, Sinquan, Aponal, Doneurin, Adapin, Mareen, Quitaxon, Espadox, Apo-doxepin, Prudoxin, Doxepin, Zonalon, Sinequan, Silenor)

Charts are based on 31372 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.

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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.