Drug Safety Information for AVENTYL (Nortriptyline hydrochloride)

Safety-related Labeling Changes for PAMELOR (NORTRIPTYLINE HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for AVENTYL* (Nortriptyline 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 AVENTYL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective*498
2Nausea484
3Pain470
4Headache451
5Fatigue*423
6Depression408
7Dizziness*382
8Completed suicide367
9Dyspnoea345
10Fall334
11Anxiety326
12Vomiting309
13Toxicity to various agents297
14Asthenia285
15Insomnia*285
16Diarrhoea285
17Pain in extremity276
18Arthralgia255
19Somnolence*248
20Hypertension225

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

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

Reason # of FDA Reports
1Product used for unknown indication4737
2Depression*2870
3Migraine*763
4Pain*648
5Headache449
6Sleep disorder413
7Insomnia400
8Fibromyalgia*318
9Anxiety*315
10Limb discomfort281

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


Types of Adverse Events for AVENTYL

Total Reports Filed with FDA: 43043


Number of FDA Adverse Event Reports by Patient Age for AVENTYL

Total Reports Filed with FDA: 43043*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Nortriptyline hydrochloride (Allegron, Nortrilen, Notriptyline, Aventyl hcl, Novo-nortriptyline, Nortryptyline, Nortriptyline, Nortriptilina, Pamelor, Norfenazin, Aventyl)

Charts are based on 43043 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 AVENTYL Reviews and Review Summary .

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.

Visit   DrugInformer.com more on AVENTYL's side effects.