LAPATINIB

N/A

Manufactured by Novartis Pharmaceuticals Corporation

32,865 FDA adverse event reports analyzed

Last updated: 2026-04-14

About LAPATINIB

LAPATINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. The most commonly reported adverse reactions for LAPATINIB include DIARRHOEA, NAUSEA, DEATH, FATIGUE, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for LAPATINIB.

Top Adverse Reactions

DIARRHOEA4,171 reports
NAUSEA1,612 reports
DEATH1,453 reports
FATIGUE1,304 reports
VOMITING1,205 reports
RASH1,061 reports
DISEASE PROGRESSION997 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME919 reports
ASTHENIA603 reports
DYSPNOEA561 reports
DRUG INEFFECTIVE559 reports
MALIGNANT NEOPLASM PROGRESSION556 reports
DEHYDRATION525 reports
PYREXIA525 reports
DECREASED APPETITE519 reports
METASTASES TO CENTRAL NERVOUS SYSTEM478 reports
NEUTROPENIA470 reports
DRY SKIN397 reports
STOMATITIS373 reports
WEIGHT DECREASED369 reports
PRURITUS367 reports
DIZZINESS365 reports
BREAST CANCER METASTATIC359 reports
MALAISE338 reports
ERYTHEMA336 reports
HEADACHE329 reports
ABDOMINAL PAIN327 reports
PAIN IN EXTREMITY323 reports
PAIN320 reports
BREAST CANCER300 reports
ANAEMIA285 reports
OFF LABEL USE284 reports
COUGH275 reports
CONSTIPATION257 reports
METASTASES TO LIVER247 reports
NEUROPATHY PERIPHERAL226 reports
PNEUMONIA225 reports
FEBRILE NEUTROPENIA223 reports
THROMBOCYTOPENIA215 reports
PLEURAL EFFUSION208 reports
HYPOKALAEMIA206 reports
METASTASES TO BONE206 reports
ABDOMINAL PAIN UPPER203 reports
METASTASES TO LUNG200 reports
GENERAL PHYSICAL HEALTH DETERIORATION196 reports
BACK PAIN191 reports
MUCOSAL INFLAMMATION190 reports
DYSPEPSIA184 reports
OEDEMA PERIPHERAL183 reports
EJECTION FRACTION DECREASED181 reports
BLOOD BILIRUBIN INCREASED179 reports
ALANINE AMINOTRANSFERASE INCREASED177 reports
EPISTAXIS175 reports
PARONYCHIA173 reports
HYPOAESTHESIA170 reports
SKIN EXFOLIATION165 reports
DYSPHAGIA163 reports
PARAESTHESIA160 reports
ALOPECIA159 reports
SKIN FISSURES157 reports
ARTHRALGIA155 reports
SEPSIS150 reports
METASTASES TO LYMPH NODES149 reports
INSOMNIA148 reports
CHEST PAIN138 reports
GAIT DISTURBANCE138 reports
SKIN DISCOLOURATION138 reports
ASPARTATE AMINOTRANSFERASE INCREASED136 reports
JAUNDICE134 reports
INFECTION133 reports
NEOPLASM PROGRESSION133 reports
BLISTER131 reports
PULMONARY EMBOLISM129 reports
ACNE128 reports
NEOPLASM MALIGNANT128 reports
LEUKOPENIA127 reports
ABDOMINAL DISCOMFORT123 reports
ADVERSE DRUG REACTION122 reports
MUSCLE SPASMS122 reports
WHITE BLOOD CELL COUNT DECREASED121 reports
HYPOTENSION117 reports
NAIL DISORDER116 reports
HEPATIC FUNCTION ABNORMAL112 reports
HEPATOTOXICITY110 reports
PRODUCT USE IN UNAPPROVED INDICATION110 reports
CELLULITIS109 reports
CHILLS108 reports
URINARY TRACT INFECTION108 reports
ADVERSE EVENT107 reports
FALL106 reports
HEPATIC ENZYME INCREASED105 reports
CONFUSIONAL STATE103 reports
ILL DEFINED DISORDER103 reports
CONVULSION102 reports
MOUTH ULCERATION101 reports
SKIN CHAPPED99 reports
HYPERSENSITIVITY97 reports
SOMNOLENCE97 reports
DERMATITIS ACNEIFORM95 reports
CARDIAC FAILURE93 reports

Report Outcomes

Out of 15,382 classified reports for LAPATINIB:

Serious 68.4%Non-Serious 31.6%

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

Female13,663 (94.9%)
Male671 (4.7%)
Unknown68 (0.5%)

Reports by Age

Age 59323 reports
Age 60320 reports
Age 55292 reports
Age 57290 reports
Age 62290 reports
Age 56282 reports
Age 63276 reports
Age 54274 reports
Age 66272 reports
Age 53271 reports
Age 58270 reports
Age 50269 reports
Age 61269 reports
Age 52267 reports
Age 51254 reports
Age 65251 reports
Age 64242 reports
Age 48230 reports
Age 47221 reports
Age 49216 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 LAPATINIB?

This profile reflects 32,865 FDA FAERS reports that mention LAPATINIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for LAPATINIB?

Frequently reported terms in FAERS include DIARRHOEA, NAUSEA, DEATH, FATIGUE, VOMITING, RASH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures LAPATINIB?

Labeling and FAERS entries often list Novartis Pharmaceuticals Corporation in connection with LAPATINIB. 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.