DURVALUMAB

N/A

Manufactured by AstraZeneca Pharmaceuticals LP

23,251 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DURVALUMAB

DURVALUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by AstraZeneca Pharmaceuticals LP. The most commonly reported adverse reactions for DURVALUMAB include DEATH, MALIGNANT NEOPLASM PROGRESSION, PNEUMONITIS, RADIATION PNEUMONITIS, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DURVALUMAB.

Top Adverse Reactions

DEATH3,167 reports
MALIGNANT NEOPLASM PROGRESSION1,390 reports
PNEUMONITIS819 reports
RADIATION PNEUMONITIS793 reports
PYREXIA574 reports
DIARRHOEA538 reports
OFF LABEL USE481 reports
DYSPNOEA435 reports
INTERSTITIAL LUNG DISEASE432 reports
PNEUMONIA413 reports
RASH387 reports
FATIGUE385 reports
NEUTROPHIL COUNT DECREASED380 reports
ASTHENIA363 reports
ANAEMIA350 reports
COLITIS321 reports
PLATELET COUNT DECREASED321 reports
METASTASES TO CENTRAL NERVOUS SYSTEM313 reports
DISEASE PROGRESSION312 reports
MYELOSUPPRESSION283 reports
NAUSEA279 reports
FEBRILE NEUTROPENIA269 reports
HYPOTHYROIDISM268 reports
THROMBOCYTOPENIA263 reports
DRUG INEFFECTIVE252 reports
DECREASED APPETITE248 reports
NEUTROPENIA234 reports
MYOCARDITIS224 reports
VOMITING222 reports
PLEURAL EFFUSION209 reports
HEPATIC FUNCTION ABNORMAL208 reports
TOXICITY TO VARIOUS AGENTS206 reports
SEPSIS204 reports
COUGH201 reports
LIVER DISORDER198 reports
CYTOKINE RELEASE SYNDROME188 reports
MALAISE188 reports
CHOLANGITIS186 reports
IMMUNE MEDIATED ENTEROCOLITIS182 reports
LUNG DISORDER169 reports
PRURITUS169 reports
ACUTE KIDNEY INJURY167 reports
ADRENAL INSUFFICIENCY159 reports
NEUROPATHY PERIPHERAL158 reports
WHITE BLOOD CELL COUNT DECREASED154 reports
HEPATITIS152 reports
GENERAL PHYSICAL HEALTH DETERIORATION151 reports
RESPIRATORY FAILURE148 reports
ARTHRALGIA143 reports
HYPERTHYROIDISM133 reports
PULMONARY TOXICITY129 reports
MYOSITIS128 reports
WEIGHT DECREASED128 reports
CONSTIPATION124 reports
ABDOMINAL PAIN122 reports
IMMUNE MEDIATED HEPATIC DISORDER121 reports
DRUG INDUCED LIVER INJURY120 reports
METASTASES TO LIVER116 reports
DEHYDRATION115 reports
METASTASES TO BONE114 reports
CONDITION AGGRAVATED113 reports
PAIN112 reports
COVID 19111 reports
CEREBROVASCULAR ACCIDENT110 reports
INFECTION110 reports
CARDIAC FAILURE109 reports
DIZZINESS107 reports
DIABETES MELLITUS104 reports
IMMUNE MEDIATED LUNG DISEASE103 reports
ALANINE AMINOTRANSFERASE INCREASED102 reports
MUSCULAR WEAKNESS101 reports
NEOPLASM PROGRESSION101 reports
RENAL IMPAIRMENT94 reports
ASPARTATE AMINOTRANSFERASE INCREASED93 reports
IMMUNE MEDIATED HEPATITIS93 reports
PANCYTOPENIA93 reports
RENAL FAILURE93 reports
HYPOTENSION92 reports
HYPERTENSION91 reports
PULMONARY EMBOLISM91 reports
LEUKOPENIA87 reports
MYASTHENIA GRAVIS87 reports
OESOPHAGITIS86 reports
CHILLS85 reports
MYALGIA84 reports
DYSPHAGIA83 reports
MYOCARDIAL INFARCTION82 reports
PANCREATITIS82 reports
URINARY TRACT INFECTION82 reports
HAEMATOTOXICITY81 reports
HEADACHE81 reports
FALL80 reports
ARTHRITIS79 reports
IMMUNE MEDIATED MYOCARDITIS79 reports
PNEUMOTHORAX79 reports
SEPTIC SHOCK79 reports
ASCITES78 reports
BACK PAIN76 reports
CEREBRAL INFARCTION76 reports
METASTASES TO LUNG76 reports

Report Outcomes

Out of 17,439 classified reports for DURVALUMAB:

Serious 95.1%Non-Serious 4.9%

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

Male9,456 (64.5%)
Female5,213 (35.5%)
Unknown1 (0.0%)

Reports by Age

Age 70492 reports
Age 68435 reports
Age 72407 reports
Age 66373 reports
Age 60359 reports
Age 71359 reports
Age 69354 reports
Age 65334 reports
Age 75333 reports
Age 73322 reports
Age 67311 reports
Age 74310 reports
Age 77270 reports
Age 64269 reports
Age 76251 reports
Age 61244 reports
Age 62244 reports
Age 58239 reports
Age 80233 reports
Age 78232 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 DURVALUMAB?

This profile reflects 23,251 FDA FAERS reports that mention DURVALUMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DURVALUMAB?

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

Who manufactures DURVALUMAB?

Labeling and FAERS entries often list AstraZeneca Pharmaceuticals LP in connection with DURVALUMAB. 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.