Lyrica

N/A

Manufactured by Viatris Specialty LLC

600,614 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Lyrica

Lyrica is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Viatris Specialty LLC. The most commonly reported adverse reactions for Lyrica include DRUG INEFFECTIVE, PAIN, FATIGUE, DIZZINESS, NAUSEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Lyrica.

Top Adverse Reactions

DRUG INEFFECTIVE26,731 reports
PAIN26,103 reports
FATIGUE15,358 reports
DIZZINESS14,675 reports
NAUSEA14,268 reports
OFF LABEL USE13,523 reports
HEADACHE12,871 reports
MALAISE12,734 reports
SOMNOLENCE11,696 reports
WEIGHT INCREASED11,504 reports
PAIN IN EXTREMITY11,284 reports
FALL10,910 reports
DYSPNOEA10,281 reports
DIARRHOEA9,992 reports
INSOMNIA9,647 reports
ARTHRALGIA9,387 reports
VOMITING8,997 reports
FEELING ABNORMAL8,849 reports
CONDITION AGGRAVATED8,600 reports
ASTHENIA8,040 reports
GAIT DISTURBANCE8,004 reports
DRUG HYPERSENSITIVITY7,425 reports
RASH7,375 reports
ANXIETY7,366 reports
PNEUMONIA7,140 reports
CONFUSIONAL STATE6,949 reports
PYREXIA6,945 reports
DEPRESSION6,665 reports
BACK PAIN6,355 reports
HYPOAESTHESIA6,350 reports
WEIGHT DECREASED6,238 reports
PRURITUS6,021 reports
MEMORY IMPAIRMENT5,650 reports
HYPERTENSION5,575 reports
PERIPHERAL SWELLING5,500 reports
VISION BLURRED5,499 reports
DEATH5,415 reports
OEDEMA PERIPHERAL5,337 reports
TREMOR5,244 reports
CONSTIPATION5,138 reports
TOXICITY TO VARIOUS AGENTS5,054 reports
JOINT SWELLING4,956 reports
DRUG INTERACTION4,920 reports
DECREASED APPETITE4,816 reports
PARAESTHESIA4,812 reports
MUSCLE SPASMS4,643 reports
RHEUMATOID ARTHRITIS4,616 reports
INTENTIONAL PRODUCT MISUSE4,567 reports
COUGH4,517 reports
WITHDRAWAL SYNDROME4,455 reports
NASOPHARYNGITIS4,432 reports
DRUG ABUSE4,380 reports
ABDOMINAL PAIN4,358 reports
DRUG INTOLERANCE4,311 reports
PRODUCT USE ISSUE4,102 reports
HYPERSENSITIVITY4,084 reports
PRODUCT USE IN UNAPPROVED INDICATION4,084 reports
INTENTIONAL PRODUCT USE ISSUE4,055 reports
ABDOMINAL PAIN UPPER4,028 reports
NEUROPATHY PERIPHERAL4,004 reports
GENERAL PHYSICAL HEALTH DETERIORATION3,967 reports
OVERDOSE3,960 reports
FIBROMYALGIA3,893 reports
ACUTE KIDNEY INJURY3,694 reports
DRY MOUTH3,687 reports
CHEST PAIN3,683 reports
INFECTION3,670 reports
SWELLING3,622 reports
MUSCULAR WEAKNESS3,615 reports
HYPERHIDROSIS3,600 reports
BALANCE DISORDER3,569 reports
URINARY TRACT INFECTION3,499 reports
LOSS OF CONSCIOUSNESS3,473 reports
HYPOTENSION3,448 reports
MUSCULOSKELETAL STIFFNESS3,439 reports
SUICIDAL IDEATION3,425 reports
MYALGIA3,394 reports
ABDOMINAL DISCOMFORT3,388 reports
BLOOD PRESSURE INCREASED3,305 reports
VISUAL IMPAIRMENT3,287 reports
ALOPECIA3,272 reports
SINUSITIS3,231 reports
DRUG DEPENDENCE3,230 reports
ANAEMIA3,199 reports
BURNING SENSATION3,144 reports
SLEEP DISORDER3,109 reports
URTICARIA2,985 reports
AMNESIA2,948 reports
MOBILITY DECREASED2,942 reports
ASTHMA2,935 reports
ARTHRITIS2,881 reports
ARTHROPATHY2,869 reports
CONTUSION2,785 reports
ERYTHEMA2,745 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE2,738 reports
MIGRAINE2,715 reports
COMA2,622 reports
CEREBROVASCULAR ACCIDENT2,616 reports
DRUG WITHDRAWAL SYNDROME2,611 reports
INFUSION RELATED REACTION2,584 reports

Report Outcomes

Out of 267,151 classified reports for Lyrica:

  • Serious: 178,065 reports (66.7%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 89,086 reports (33.3%)
Serious 66.7%Non-Serious 33.3%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female160,472 (65.4%)
Male83,334 (33.9%)
Unknown1,709 (0.7%)

Reports by Age

Age 604,664 reports
Age 654,258 reports
Age 594,253 reports
Age 644,249 reports
Age 584,213 reports
Age 614,212 reports
Age 624,201 reports
Age 634,079 reports
Age 554,047 reports
Age 573,981 reports
Age 563,933 reports
Age 673,835 reports
Age 683,832 reports
Age 713,770 reports
Age 543,761 reports
Age 663,757 reports
Age 703,707 reports
Age 533,698 reports
Age 693,539 reports
Age 723,396 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with Lyrica?

This profile reflects 600,614 FDA FAERS reports that mention Lyrica. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Lyrica?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, PAIN, FATIGUE, DIZZINESS, NAUSEA, OFF LABEL USE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Lyrica?

Labeling and FAERS entries often list Viatris Specialty LLC in connection with Lyrica. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.