GEFITINIB

N/A

Manufactured by AstraZeneca Pharmaceuticals LP

17,300 FDA adverse event reports analyzed

Last updated: 2026-04-14

About GEFITINIB

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

Top Adverse Reactions

MALIGNANT NEOPLASM PROGRESSION1,811 reports
DRUG RESISTANCE1,246 reports
DIARRHOEA900 reports
DEATH753 reports
RASH638 reports
DISEASE PROGRESSION456 reports
INTERSTITIAL LUNG DISEASE419 reports
NAUSEA376 reports
METASTASES TO CENTRAL NERVOUS SYSTEM373 reports
DYSPNOEA331 reports
VOMITING325 reports
DRUG INEFFECTIVE297 reports
PNEUMONIA270 reports
PYREXIA267 reports
ACQUIRED GENE MUTATION258 reports
HEPATIC FUNCTION ABNORMAL246 reports
PLEURAL EFFUSION241 reports
FATIGUE239 reports
DECREASED APPETITE232 reports
LUNG DISORDER218 reports
ASTHENIA207 reports
OFF LABEL USE204 reports
COUGH192 reports
DRY SKIN192 reports
METASTASES TO BONE177 reports
PRURITUS174 reports
DEHYDRATION173 reports
LIVER DISORDER169 reports
ANAEMIA163 reports
WEIGHT DECREASED153 reports
RESPIRATORY FAILURE140 reports
ALANINE AMINOTRANSFERASE INCREASED137 reports
EGFR GENE MUTATION128 reports
PARONYCHIA124 reports
HEADACHE118 reports
ASPARTATE AMINOTRANSFERASE INCREASED117 reports
DIZZINESS117 reports
METASTASES TO MENINGES117 reports
PULMONARY EMBOLISM117 reports
METASTASES TO LIVER114 reports
PAIN110 reports
ALOPECIA106 reports
ACNE105 reports
CONDITION AGGRAVATED104 reports
DRUG INTERACTION103 reports
MALAISE103 reports
STOMATITIS102 reports
THROMBOCYTOPENIA102 reports
ANOREXIA100 reports
ABDOMINAL PAIN99 reports
METASTASES TO LUNG99 reports
FALL95 reports
GENERAL PHYSICAL HEALTH DETERIORATION95 reports
HAEMOPTYSIS89 reports
NEOPLASM PROGRESSION86 reports
DERMATITIS ACNEIFORM84 reports
NEUTROPENIA84 reports
METASTASIS82 reports
PNEUMONITIS82 reports
OEDEMA PERIPHERAL81 reports
ERYTHEMA80 reports
LUNG NEOPLASM MALIGNANT79 reports
HYPOXIA78 reports
CARDIAC FAILURE77 reports
HEPATOTOXICITY77 reports
INFECTION77 reports
SKIN DISORDER77 reports
CONSTIPATION73 reports
DYSPHAGIA71 reports
PLATELET COUNT DECREASED71 reports
URINARY TRACT INFECTION70 reports
HYPOTENSION69 reports
MALIGNANT TRANSFORMATION69 reports
CHEST PAIN68 reports
BACK PAIN67 reports
PAIN IN EXTREMITY66 reports
RENAL FAILURE66 reports
RENAL IMPAIRMENT65 reports
CONFUSIONAL STATE63 reports
HYPERTENSION63 reports
MUCOSAL INFLAMMATION59 reports
SEPSIS58 reports
ABDOMINAL PAIN UPPER57 reports
DEPRESSED LEVEL OF CONSCIOUSNESS56 reports
BLOOD CREATININE INCREASED55 reports
HAEMOGLOBIN DECREASED55 reports
FEBRILE NEUTROPENIA54 reports
LEUKOPENIA54 reports
WHITE BLOOD CELL COUNT DECREASED53 reports
GASTROINTESTINAL HAEMORRHAGE51 reports
CEREBRAL INFARCTION50 reports
HYPONATRAEMIA50 reports
DEEP VEIN THROMBOSIS49 reports
METASTASES TO LYMPH NODES49 reports
DYSPEPSIA48 reports
PERICARDIAL EFFUSION48 reports
SKIN EXFOLIATION48 reports
LIVER FUNCTION TEST ABNORMAL47 reports
SOMNOLENCE47 reports
HEPATITIS46 reports

Report Outcomes

Out of 8,919 classified reports for GEFITINIB:

Serious 94.7%Non-Serious 5.3%

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

Female4,789 (59.6%)
Male3,232 (40.2%)
Unknown13 (0.2%)

Reports by Age

Age 70249 reports
Age 60203 reports
Age 65160 reports
Age 69159 reports
Age 72157 reports
Age 80157 reports
Age 66153 reports
Age 64151 reports
Age 63150 reports
Age 75149 reports
Age 67146 reports
Age 68146 reports
Age 74145 reports
Age 76139 reports
Age 71138 reports
Age 62135 reports
Age 73135 reports
Age 77131 reports
Age 57129 reports
Age 59122 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 GEFITINIB?

This profile reflects 17,300 FDA FAERS reports that mention GEFITINIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for GEFITINIB?

Frequently reported terms in FAERS include MALIGNANT NEOPLASM PROGRESSION, DRUG RESISTANCE, DIARRHOEA, DEATH, RASH, DISEASE PROGRESSION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures GEFITINIB?

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