IRINOTECAN HYDROCHLORIDE

N/A

Manufactured by Pharmacia & Upjohn Company LLC

23,035 FDA adverse event reports analyzed

Last updated: 2026-04-14

About IRINOTECAN HYDROCHLORIDE

IRINOTECAN HYDROCHLORIDE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pharmacia & Upjohn Company LLC. The most commonly reported adverse reactions for IRINOTECAN HYDROCHLORIDE include DIARRHOEA, OFF LABEL USE, NAUSEA, DEATH, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IRINOTECAN HYDROCHLORIDE.

Top Adverse Reactions

DIARRHOEA1,601 reports
OFF LABEL USE1,022 reports
NAUSEA895 reports
DEATH854 reports
VOMITING803 reports
DISEASE PROGRESSION672 reports
MYELOSUPPRESSION618 reports
NEUTROPENIA604 reports
FEBRILE NEUTROPENIA580 reports
FATIGUE518 reports
PYREXIA500 reports
MALIGNANT NEOPLASM PROGRESSION477 reports
ASTHENIA473 reports
ABDOMINAL PAIN445 reports
NEUROPATHY PERIPHERAL412 reports
NEOPLASM PROGRESSION379 reports
DECREASED APPETITE375 reports
NEUTROPHIL COUNT DECREASED362 reports
DEHYDRATION353 reports
WHITE BLOOD CELL COUNT DECREASED350 reports
ANAEMIA346 reports
THROMBOCYTOPENIA284 reports
DYSPNOEA277 reports
DRUG INEFFECTIVE268 reports
STOMATITIS250 reports
MALAISE249 reports
PRODUCT USE IN UNAPPROVED INDICATION241 reports
SEPSIS238 reports
RASH229 reports
PULMONARY EMBOLISM226 reports
PLATELET COUNT DECREASED216 reports
INTERSTITIAL LUNG DISEASE209 reports
WEIGHT DECREASED201 reports
HYPOTENSION199 reports
LEUKOPENIA195 reports
PNEUMONIA193 reports
HYPOKALAEMIA191 reports
HYPERTENSION188 reports
CONSTIPATION186 reports
PAIN181 reports
HAEMOGLOBIN DECREASED176 reports
GENERAL PHYSICAL HEALTH DETERIORATION172 reports
DIZZINESS165 reports
METASTASES TO LIVER147 reports
MUCOSAL INFLAMMATION145 reports
PANCYTOPENIA142 reports
ACUTE KIDNEY INJURY137 reports
BONE MARROW FAILURE136 reports
DERMATITIS ACNEIFORM134 reports
ASCITES128 reports
DEEP VEIN THROMBOSIS123 reports
PRODUCT USE ISSUE122 reports
PARAESTHESIA121 reports
INFECTION119 reports
COLON CANCER118 reports
DYSARTHRIA114 reports
INTESTINAL OBSTRUCTION113 reports
BACK PAIN112 reports
ABDOMINAL PAIN UPPER111 reports
COLITIS111 reports
SEPTIC SHOCK111 reports
TACHYCARDIA110 reports
CHILLS108 reports
HEADACHE108 reports
PRURITUS108 reports
ALOPECIA104 reports
FALL102 reports
HYPONATRAEMIA99 reports
HYPOMAGNESAEMIA97 reports
ALANINE AMINOTRANSFERASE INCREASED95 reports
ASPARTATE AMINOTRANSFERASE INCREASED93 reports
HYPERSENSITIVITY93 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME93 reports
ERYTHEMA92 reports
TOXICITY TO VARIOUS AGENTS91 reports
CONDITION AGGRAVATED90 reports
RESPIRATORY FAILURE90 reports
NEUROTOXICITY89 reports
CHEST PAIN88 reports
EPISTAXIS88 reports
HEPATIC FUNCTION ABNORMAL87 reports
HYPOAESTHESIA87 reports
CONFUSIONAL STATE85 reports
URINARY TRACT INFECTION85 reports
BLOOD CREATININE INCREASED84 reports
HYPOPHAGIA84 reports
HYPERHIDROSIS83 reports
BLOOD PRESSURE INCREASED82 reports
GASTROINTESTINAL HAEMORRHAGE82 reports
ABDOMINAL DISTENSION81 reports
PROTEINURIA79 reports
THROMBOSIS79 reports
INFUSION RELATED REACTION77 reports
BLOOD BILIRUBIN INCREASED75 reports
DYSPHAGIA75 reports
RENAL FAILURE73 reports
METASTASES TO LUNG72 reports
ENTEROCOLITIS70 reports
MUSCULAR WEAKNESS70 reports
PARONYCHIA70 reports

Report Outcomes

Out of 12,001 classified reports for IRINOTECAN HYDROCHLORIDE:

Serious 91.9%Non-Serious 8.1%

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

Male6,130 (57.6%)
Female4,452 (41.9%)
Unknown55 (0.5%)

Reports by Age

Age 65317 reports
Age 70301 reports
Age 67290 reports
Age 63285 reports
Age 73279 reports
Age 64278 reports
Age 61266 reports
Age 62266 reports
Age 69266 reports
Age 72261 reports
Age 68258 reports
Age 71251 reports
Age 66250 reports
Age 57238 reports
Age 60236 reports
Age 56235 reports
Age 59235 reports
Age 75214 reports
Age 58210 reports
Age 76195 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 IRINOTECAN HYDROCHLORIDE?

This profile reflects 23,035 FDA FAERS reports that mention IRINOTECAN HYDROCHLORIDE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for IRINOTECAN HYDROCHLORIDE?

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

Who manufactures IRINOTECAN HYDROCHLORIDE?

Labeling and FAERS entries often list Pharmacia & Upjohn Company LLC in connection with IRINOTECAN 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.