ERLOTINIB

N/A

Manufactured by Armas Pharmaceuticals Inc.

20,267 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ERLOTINIB

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

Top Adverse Reactions

DEATH2,896 reports
RASH1,067 reports
DIARRHOEA1,000 reports
OFF LABEL USE792 reports
MALIGNANT NEOPLASM PROGRESSION765 reports
FATIGUE580 reports
NAUSEA538 reports
DRUG RESISTANCE464 reports
VOMITING451 reports
DISEASE PROGRESSION440 reports
ASTHENIA377 reports
DECREASED APPETITE374 reports
DYSPNOEA353 reports
MALAISE352 reports
ANAEMIA342 reports
DRUG INEFFECTIVE330 reports
PNEUMONIA286 reports
PAIN265 reports
PYREXIA251 reports
DEHYDRATION243 reports
WEIGHT DECREASED236 reports
NEUTROPENIA225 reports
HYPERTENSION218 reports
ABDOMINAL PAIN210 reports
COUGH206 reports
PLEURAL EFFUSION190 reports
DERMATITIS ACNEIFORM182 reports
CONSTIPATION178 reports
DRY SKIN165 reports
THROMBOCYTOPENIA165 reports
PRURITUS164 reports
ALOPECIA148 reports
PULMONARY EMBOLISM146 reports
FALL140 reports
DIZZINESS138 reports
RESPIRATORY FAILURE129 reports
HEADACHE127 reports
LUNG NEOPLASM MALIGNANT127 reports
GENERAL PHYSICAL HEALTH DETERIORATION126 reports
ACNE120 reports
BACK PAIN114 reports
DRUG INTERACTION114 reports
PARONYCHIA112 reports
INFECTION108 reports
STOMATITIS102 reports
METASTASES TO CENTRAL NERVOUS SYSTEM101 reports
LEUKOPENIA99 reports
PROTEINURIA97 reports
HYPOTENSION94 reports
INTERSTITIAL LUNG DISEASE94 reports
OEDEMA PERIPHERAL94 reports
EPISTAXIS93 reports
HYPOKALAEMIA93 reports
ASPARTATE AMINOTRANSFERASE INCREASED90 reports
CONFUSIONAL STATE90 reports
HYPONATRAEMIA90 reports
ARTHRALGIA88 reports
SEPSIS88 reports
ALANINE AMINOTRANSFERASE INCREASED87 reports
DYSPHAGIA87 reports
HAEMOPTYSIS87 reports
PNEUMONITIS84 reports
NEUROPATHY PERIPHERAL82 reports
NON SMALL CELL LUNG CANCER81 reports
MUCOSAL INFLAMMATION79 reports
CHEST PAIN78 reports
ABDOMINAL PAIN UPPER77 reports
METASTASES TO BONE77 reports
PAIN IN EXTREMITY77 reports
CEREBROVASCULAR ACCIDENT76 reports
DEEP VEIN THROMBOSIS76 reports
RENAL FAILURE76 reports
HAEMATOTOXICITY75 reports
GASTROINTESTINAL HAEMORRHAGE74 reports
HAEMORRHAGE74 reports
ACUTE KIDNEY INJURY73 reports
FEBRILE NEUTROPENIA73 reports
METASTASES TO LIVER73 reports
METASTASES TO LUNG73 reports
THERAPY PARTIAL RESPONDER73 reports
NEOPLASM PROGRESSION72 reports
DEPRESSION71 reports
GAIT DISTURBANCE71 reports
SKIN TOXICITY69 reports
DRUG INTOLERANCE68 reports
ERYTHEMA67 reports
SKIN EXFOLIATION67 reports
HAEMOGLOBIN DECREASED65 reports
PLATELET COUNT DECREASED65 reports
ANXIETY64 reports
NASOPHARYNGITIS64 reports
ASCITES63 reports
CARDIAC FAILURE62 reports
METASTASIS62 reports
OEDEMA62 reports
DYSPEPSIA61 reports
INSOMNIA61 reports
RASH PUSTULAR60 reports
EMBOLISM57 reports
MYOCARDIAL INFARCTION57 reports

Report Outcomes

Out of 9,562 classified reports for ERLOTINIB:

Serious 97.6%Non-Serious 2.4%

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

Female4,082 (50.7%)
Male3,909 (48.6%)
Unknown53 (0.7%)

Reports by Age

Age 67185 reports
Age 70185 reports
Age 66176 reports
Age 72175 reports
Age 75169 reports
Age 65161 reports
Age 69161 reports
Age 68159 reports
Age 63155 reports
Age 64153 reports
Age 74149 reports
Age 79149 reports
Age 71148 reports
Age 73148 reports
Age 59147 reports
Age 76141 reports
Age 57140 reports
Age 61137 reports
Age 60132 reports
Age 58128 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 ERLOTINIB?

This profile reflects 20,267 FDA FAERS reports that mention ERLOTINIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ERLOTINIB?

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

Who manufactures ERLOTINIB?

Labeling and FAERS entries often list Armas Pharmaceuticals Inc. in connection with ERLOTINIB. 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.