Cymbalta

N/A

Manufactured by Eli Lilly and Company

439,614 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Cymbalta

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

Top Adverse Reactions

NAUSEA17,699 reports
FATIGUE15,796 reports
DRUG INEFFECTIVE13,910 reports
HEADACHE13,507 reports
DIZZINESS13,252 reports
PAIN12,206 reports
DIARRHOEA9,854 reports
INSOMNIA9,750 reports
OFF LABEL USE9,736 reports
ANXIETY9,598 reports
VOMITING8,408 reports
DEPRESSION8,278 reports
DRUG WITHDRAWAL SYNDROME8,145 reports
FALL7,770 reports
PARAESTHESIA7,391 reports
ARTHRALGIA7,100 reports
HYPERHIDROSIS6,883 reports
FEELING ABNORMAL6,789 reports
MALAISE6,452 reports
DYSPNOEA6,351 reports
SUICIDAL IDEATION6,293 reports
ASTHENIA5,850 reports
CONFUSIONAL STATE5,723 reports
TREMOR5,550 reports
SOMNOLENCE5,428 reports
PAIN IN EXTREMITY5,139 reports
WEIGHT INCREASED4,937 reports
BACK PAIN4,804 reports
AGITATION4,701 reports
IRRITABILITY4,488 reports
WEIGHT DECREASED4,466 reports
PNEUMONIA4,111 reports
CONSTIPATION4,091 reports
RASH4,056 reports
GAIT DISTURBANCE4,041 reports
VERTIGO3,916 reports
DRUG INTERACTION3,910 reports
PRURITUS3,895 reports
CONDITION AGGRAVATED3,778 reports
DECREASED APPETITE3,662 reports
MEMORY IMPAIRMENT3,559 reports
COUGH3,511 reports
HYPERTENSION3,446 reports
BLOOD PRESSURE INCREASED3,325 reports
ABDOMINAL PAIN UPPER3,291 reports
PYREXIA3,248 reports
ABDOMINAL PAIN3,225 reports
DEATH3,215 reports
URINARY TRACT INFECTION3,190 reports
DRUG HYPERSENSITIVITY3,174 reports
MUSCLE SPASMS3,122 reports
HYPOAESTHESIA3,062 reports
MIGRAINE2,813 reports
AFFECT LABILITY2,790 reports
NIGHTMARE2,785 reports
COMPLETED SUICIDE2,699 reports
TOXICITY TO VARIOUS AGENTS2,672 reports
PRODUCT DOSE OMISSION ISSUE2,650 reports
LOSS OF CONSCIOUSNESS2,640 reports
CHEST PAIN2,626 reports
NASOPHARYNGITIS2,616 reports
VISION BLURRED2,567 reports
SLEEP DISORDER2,488 reports
HYPOTENSION2,410 reports
TINNITUS2,408 reports
LETHARGY2,397 reports
MYALGIA2,372 reports
BALANCE DISORDER2,369 reports
DYSPHORIA2,345 reports
RHEUMATOID ARTHRITIS2,342 reports
SINUSITIS2,312 reports
ABDOMINAL DISCOMFORT2,277 reports
DRY MOUTH2,271 reports
ACUTE KIDNEY INJURY2,249 reports
ALOPECIA2,246 reports
MUSCULAR WEAKNESS2,234 reports
NEUROPATHY PERIPHERAL2,232 reports
PERIPHERAL SWELLING2,173 reports
WITHDRAWAL SYNDROME2,152 reports
PALPITATIONS2,143 reports
CRYING2,133 reports
DRUG DOSE OMISSION2,120 reports
SUICIDE ATTEMPT2,112 reports
DEPRESSED MOOD2,102 reports
PRODUCT USE IN UNAPPROVED INDICATION2,086 reports
INJECTION SITE PAIN2,073 reports
INTENTIONAL PRODUCT MISUSE2,060 reports
COVID 192,019 reports
HALLUCINATION2,011 reports
FIBROMYALGIA2,004 reports
SEROTONIN SYNDROME2,001 reports
OVERDOSE1,999 reports
DISTURBANCE IN ATTENTION1,995 reports
HYPERSENSITIVITY1,988 reports
CHRONIC KIDNEY DISEASE1,987 reports
SEIZURE1,932 reports
MOOD SWINGS1,918 reports
GASTROOESOPHAGEAL REFLUX DISEASE1,912 reports
MUSCULOSKELETAL STIFFNESS1,904 reports
RENAL FAILURE1,898 reports

Report Outcomes

Out of 184,113 classified reports for Cymbalta:

  • Serious: 113,312 reports (61.5%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 70,801 reports (38.5%)
Serious 61.5%Non-Serious 38.5%

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

Female127,854 (74.0%)
Male44,499 (25.8%)
Unknown342 (0.2%)

Reports by Age

Age 553,207 reports
Age 533,188 reports
Age 603,061 reports
Age 502,987 reports
Age 572,966 reports
Age 562,960 reports
Age 612,902 reports
Age 592,827 reports
Age 582,820 reports
Age 622,778 reports
Age 542,759 reports
Age 642,747 reports
Age 522,721 reports
Age 652,717 reports
Age 632,596 reports
Age 512,478 reports
Age 452,466 reports
Age 662,338 reports
Age 492,300 reports
Age 682,251 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 Cymbalta?

This profile reflects 439,614 FDA FAERS reports that mention Cymbalta. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Cymbalta?

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

Who manufactures Cymbalta?

Labeling and FAERS entries often list Eli Lilly and Company in connection with Cymbalta. 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.