Keytruda

N/A

Manufactured by Merck Sharp & Dohme LLC

159,170 FDA adverse event reports analyzed

Last updated: 2026-05-19

About Keytruda

Keytruda is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Merck Sharp & Dohme LLC. The most commonly reported adverse reactions for Keytruda include MALIGNANT NEOPLASM PROGRESSION, DEATH, DIARRHOEA, FATIGUE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for Keytruda.

Top Adverse Reactions

MALIGNANT NEOPLASM PROGRESSION11,562 reports
DEATH5,718 reports
DIARRHOEA5,487 reports
FATIGUE4,928 reports
OFF LABEL USE4,623 reports
PYREXIA3,745 reports
RASH3,554 reports
PRODUCT USE IN UNAPPROVED INDICATION3,468 reports
NAUSEA3,449 reports
DECREASED APPETITE3,216 reports
HYPERTENSION3,102 reports
HYPOTHYROIDISM2,799 reports
ASTHENIA2,688 reports
DRUG INEFFECTIVE2,498 reports
PRODUCT USE ISSUE2,494 reports
INTERSTITIAL LUNG DISEASE2,434 reports
MALAISE2,328 reports
ACUTE KIDNEY INJURY2,314 reports
ANAEMIA2,276 reports
DYSPNOEA2,269 reports
NEUTROPENIA2,251 reports
PNEUMONIA2,135 reports
PNEUMONITIS2,134 reports
VOMITING2,130 reports
NEUROPATHY PERIPHERAL1,898 reports
COLITIS1,858 reports
ARTHRALGIA1,855 reports
WEIGHT DECREASED1,774 reports
THROMBOCYTOPENIA1,703 reports
RENAL IMPAIRMENT1,688 reports
PRURITUS1,666 reports
PLATELET COUNT DECREASED1,599 reports
THERAPY PARTIAL RESPONDER1,575 reports
ADRENAL INSUFFICIENCY1,547 reports
FEBRILE NEUTROPENIA1,491 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION1,488 reports
CONSTIPATION1,377 reports
ADVERSE EVENT1,335 reports
PAIN1,312 reports
HEADACHE1,297 reports
HEPATIC FUNCTION ABNORMAL1,275 reports
PANCYTOPENIA1,253 reports
MYOCARDITIS1,219 reports
GENERAL PHYSICAL HEALTH DETERIORATION1,182 reports
STOMATITIS1,137 reports
BLOOD PRESSURE INCREASED1,127 reports
ABDOMINAL PAIN1,116 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME1,111 reports
COUGH1,095 reports
DEHYDRATION1,073 reports
HEPATITIS1,059 reports
SEPSIS1,046 reports
IMMUNE MEDIATED ENTEROCOLITIS1,018 reports
DISEASE PROGRESSION1,000 reports
MYALGIA986 reports
IMMUNE MEDIATED HEPATIC DISORDER979 reports
MYELOSUPPRESSION971 reports
TUBULOINTERSTITIAL NEPHRITIS967 reports
PROTEINURIA957 reports
PLEURAL EFFUSION949 reports
RENAL FAILURE939 reports
HYPOTENSION922 reports
DYSPHONIA906 reports
CARDIAC FAILURE890 reports
PULMONARY EMBOLISM886 reports
HYPERTHYROIDISM879 reports
NEUTROPHIL COUNT DECREASED835 reports
DIZZINESS829 reports
URINARY TRACT INFECTION806 reports
RESPIRATORY FAILURE805 reports
ALANINE AMINOTRANSFERASE INCREASED796 reports
BACK PAIN769 reports
PAIN IN EXTREMITY742 reports
IMMUNE MEDIATED ADVERSE REACTION739 reports
HEPATIC CYTOLYSIS723 reports
ASPARTATE AMINOTRANSFERASE INCREASED721 reports
ERYTHEMA717 reports
HYPONATRAEMIA715 reports
NEOPLASM PROGRESSION696 reports
TYPE 1 DIABETES MELLITUS685 reports
IMMUNE MEDIATED MYOCARDITIS682 reports
CONDITION AGGRAVATED679 reports
DYSPHAGIA672 reports
MYOSITIS655 reports
IMMUNE MEDIATED HEPATITIS650 reports
WHITE BLOOD CELL COUNT DECREASED650 reports
NO ADVERSE EVENT648 reports
MUSCULAR WEAKNESS640 reports
HEPATIC ENZYME INCREASED635 reports
OEDEMA PERIPHERAL628 reports
IMMUNE MEDIATED HYPOTHYROIDISM626 reports
HEPATOTOXICITY619 reports
BLOOD CREATININE INCREASED608 reports
INFECTION604 reports
MUCOSAL INFLAMMATION604 reports
LIVER DISORDER602 reports
LEUKOPENIA601 reports
ALOPECIA598 reports
IMMUNE MEDIATED LUNG DISEASE593 reports
SKIN DISORDER591 reports

Report Outcomes

Out of 100,423 classified reports for Keytruda:

  • Serious: 87,622 reports (87.3%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 12,801 reports (12.7%)
Serious 87.3%Non-Serious 12.7%

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

Female47,325 (50.3%)
Male46,785 (49.7%)
Unknown6 (0.0%)

Reports by Age

Age 702,550 reports
Age 712,506 reports
Age 722,503 reports
Age 692,385 reports
Age 682,374 reports
Age 672,363 reports
Age 652,347 reports
Age 732,261 reports
Age 662,245 reports
Age 742,242 reports
Age 632,104 reports
Age 752,103 reports
Age 622,061 reports
Age 642,020 reports
Age 602,004 reports
Age 611,952 reports
Age 81,919 reports
Age 761,877 reports
Age 771,682 reports
Age 581,660 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 Keytruda?

This profile reflects 159,170 FDA FAERS reports that mention Keytruda. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for Keytruda?

Frequently reported terms in FAERS include MALIGNANT NEOPLASM PROGRESSION, DEATH, DIARRHOEA, FATIGUE, OFF LABEL USE, PYREXIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures Keytruda?

Labeling and FAERS entries often list Merck Sharp & Dohme LLC in connection with Keytruda. Always verify the specific product and NDC with your pharmacist.

Other Drugs by Merck Sharp & Dohme LLC

Explore other medications manufactured by Merck Sharp & Dohme LLC and compare their safety profiles:

APREPITANT (85/100)FOSAPREPITANT DIMEGLUMINE (85/100)IVERMECTIN (72/100)JanuviaPEMBROLIZUMAB (85/100)POSACONAZOLE (85/100)RALTEGRAVIR (85/100)SITAGLIPTIN (65/100)TEMOZOLOMIDE (85/100)

View all Merck Sharp & Dohme LLC drugs →

Drugs Also Linked to MALIGNANT NEOPLASM PROGRESSION

The following drugs share commonly reported adverse reactions with Keytruda:

ABEMACICLIB (78/100)ABIRATERONE ACETATE (72/100)ACALABRUTINIB (78/100)ALPELISIB (78/100)ANASTROZOLE (60/100)ANASTROZOLE TABLETS (75/100)BENDAMUSTINE HYDROCHLORIDE (85/100)BERBERIS VULGARIS ROOT BARK (15/100)BEVACIZUMAB (85/100)BICALUTAMIDE (85/100)BINIMETINIB (85/100)CABOZANTINIB (72/100)

View all drugs reporting MALIGNANT NEOPLASM PROGRESSION →

Explore More

Safety RankingsSearch All DrugsCompare DrugsMerck Sharp & Dohme LLC PortfolioMALIGNANT NEOPLASM PROGRESSION in Other DrugsDEATH in Other DrugsDIARRHOEA in Other Drugs
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.