Drug Safety Information for LYRICA (Pregabalin)

Safety-related Labeling Changes for LYRICA CR (PREGABALIN) Rx Drug: FDA Link

Adverse Drug Reactions for LYRICA* (Pregabalin)

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 LYRICA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Pain*8776
2Drug ineffective8190
3Dizziness*5925
4Weight increased*5314
5Somnolence*4604
6Nausea3847
7Malaise3613
8Fatigue*3559
9Pain in extremity3556
10Feeling abnormal3535
11Headache3284
12Fall3229
13Oedema peripheral3222
14Vision blurred*2996
15Insomnia*2934
16Dyspnoea2699
17Gait disturbance2650
18Depression*2328
19Vomiting2201
20Diarrhoea2196

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

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

Reason # of FDA Reports
1Fibromyalgia*41449
2Neuralgia*30226
3Product used for unknown indication22665
4Pain17366
5Neuropathy peripheral*17110
6Diabetic neuropathy*7665
7Back pain*3675
8Post herpetic neuralgia*3540
9Herpes zoster*2839
10Pain in extremity2789

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


Types of Adverse Events for LYRICA

Total Reports Filed with FDA: 335855


Number of FDA Adverse Event Reports by Patient Age for LYRICA

Total Reports Filed with FDA: 335855*


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

Charts are based on 335855 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 LYRICA 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.