Drug Safety Information for ELAVIL (Amitriptyline hydrochloride)

Safety-related Labeling Changes for LIMBITROL (AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE) Rx Drug: FDA Link

Adverse Drug Reactions for ELAVIL* (Amitriptyline 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 ELAVIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain2140
2Nausea2095
3Headache1842
4Drug ineffective1757
5Fatigue*1685
6Dyspnoea1674
7Dizziness*1605
8Depression1468
9Anxiety1437
10Vomiting1434
11Fall1407
12Diarrhoea1399
13Toxicity to various agents1328
14Completed suicide1291
15Asthenia1265
16Pain in extremity1240
17Arthralgia1174
18Insomnia1158
19Malaise1083
20Confusional state1021

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

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

Reason # of FDA Reports
1Product used for unknown indication22076
2Depression*9682
3Insomnia*4000
4Pain*3872
5Sleep disorder3326
6Neuralgia2359
7Migraine*1802
8Fibromyalgia*1564
9Headache1042
10Anxiety*985

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


Types of Adverse Events for ELAVIL

Total Reports Filed with FDA: 191633

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Male Patients
Male
Female Patients
Female
Unknown Patients
Unknown


Number of FDA Adverse Event Reports by Patient Age for ELAVIL

Total Reports Filed with FDA: 191633*

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Note: * Reports include 29,872 reports of unknown age.


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Amitriptyline hydrochloride (Amitriptyline, Amitriptilina, Amitid, Endep, Amitril, Elavil)

Charts are based on 191633 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 ELAVIL 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 ELAVIL's side effects.