ERLOTINIB HYDROCHLORIDE

N/A

Manufactured by Armas Pharmaceuticals Inc.

25,894 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ERLOTINIB HYDROCHLORIDE

ERLOTINIB HYDROCHLORIDE 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 HYDROCHLORIDE include DEATH, DIARRHOEA, RASH, 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 HYDROCHLORIDE.

Top Adverse Reactions

DEATH3,653 reports
DIARRHOEA1,324 reports
RASH1,310 reports
OFF LABEL USE894 reports
MALIGNANT NEOPLASM PROGRESSION887 reports
FATIGUE717 reports
NAUSEA692 reports
VOMITING576 reports
DISEASE PROGRESSION562 reports
DECREASED APPETITE510 reports
ANAEMIA497 reports
DYSPNOEA483 reports
DRUG RESISTANCE472 reports
ASTHENIA462 reports
PNEUMONIA417 reports
DEHYDRATION380 reports
MALAISE379 reports
DRUG INEFFECTIVE346 reports
PYREXIA343 reports
PAIN308 reports
WEIGHT DECREASED277 reports
PLEURAL EFFUSION267 reports
NEUTROPENIA264 reports
ABDOMINAL PAIN260 reports
HYPERTENSION242 reports
COUGH239 reports
PULMONARY EMBOLISM234 reports
DERMATITIS ACNEIFORM221 reports
CONSTIPATION220 reports
THROMBOCYTOPENIA209 reports
NEOPLASM MALIGNANT207 reports
INCORRECT DOSE ADMINISTERED195 reports
DRY SKIN191 reports
PRURITUS187 reports
FALL183 reports
GENERAL PHYSICAL HEALTH DETERIORATION179 reports
RESPIRATORY FAILURE178 reports
LUNG NEOPLASM MALIGNANT171 reports
DIZZINESS167 reports
INTERSTITIAL LUNG DISEASE159 reports
ALOPECIA158 reports
HEADACHE148 reports
BACK PAIN146 reports
DRUG INTERACTION146 reports
HYPOTENSION145 reports
STOMATITIS144 reports
HYPONATRAEMIA143 reports
INFECTION141 reports
HAEMOGLOBIN DECREASED139 reports
NON SMALL CELL LUNG CANCER135 reports
SEPSIS135 reports
ACNE133 reports
CONFUSIONAL STATE132 reports
METASTASES TO CENTRAL NERVOUS SYSTEM130 reports
PARONYCHIA130 reports
HYPOKALAEMIA129 reports
OEDEMA PERIPHERAL129 reports
ASPARTATE AMINOTRANSFERASE INCREASED122 reports
EPISTAXIS122 reports
HAEMOPTYSIS120 reports
DYSPHAGIA119 reports
ALANINE AMINOTRANSFERASE INCREASED117 reports
NEOPLASM PROGRESSION117 reports
CHEST PAIN113 reports
FEBRILE NEUTROPENIA113 reports
LEUKOPENIA113 reports
PLATELET COUNT DECREASED113 reports
RENAL FAILURE111 reports
PNEUMONITIS110 reports
GASTROINTESTINAL HAEMORRHAGE106 reports
ARTHRALGIA105 reports
MUCOSAL INFLAMMATION104 reports
DEEP VEIN THROMBOSIS102 reports
PROTEINURIA99 reports
CEREBROVASCULAR ACCIDENT92 reports
ABDOMINAL PAIN UPPER91 reports
METASTASES TO LIVER91 reports
NEUROPATHY PERIPHERAL91 reports
HAEMORRHAGE90 reports
METASTASES TO BONE90 reports
URINARY TRACT INFECTION90 reports
ASCITES88 reports
PAIN IN EXTREMITY88 reports
HYPOXIA87 reports
GAIT DISTURBANCE86 reports
METASTASES TO LUNG84 reports
ERYTHEMA83 reports
ACUTE KIDNEY INJURY82 reports
ANXIETY81 reports
BLOOD BILIRUBIN INCREASED80 reports
HAEMATOTOXICITY80 reports
CARDIAC FAILURE78 reports
DEPRESSION78 reports
DYSPEPSIA78 reports
LUNG ADENOCARCINOMA78 reports
INSOMNIA77 reports
ATRIAL FIBRILLATION76 reports
WHITE BLOOD CELL COUNT DECREASED76 reports
SKIN EXFOLIATION75 reports
MUSCULAR WEAKNESS73 reports

Report Outcomes

Out of 12,360 classified reports for ERLOTINIB HYDROCHLORIDE:

Serious 97.9%Non-Serious 2.1%

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

Female5,318 (50.0%)
Male5,255 (49.4%)
Unknown56 (0.5%)

Reports by Age

Age 67227 reports
Age 66222 reports
Age 70219 reports
Age 72214 reports
Age 69207 reports
Age 65197 reports
Age 75196 reports
Age 68192 reports
Age 64187 reports
Age 71187 reports
Age 73186 reports
Age 63182 reports
Age 74177 reports
Age 59173 reports
Age 58167 reports
Age 79167 reports
Age 60166 reports
Age 76165 reports
Age 61164 reports
Age 57157 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 HYDROCHLORIDE?

This profile reflects 25,894 FDA FAERS reports that mention ERLOTINIB HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ERLOTINIB HYDROCHLORIDE?

Frequently reported terms in FAERS include DEATH, DIARRHOEA, RASH, 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 HYDROCHLORIDE?

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