AXITINIB

N/A

Manufactured by Pfizer Laboratories Div Pfizer Inc

37,114 FDA adverse event reports analyzed

Last updated: 2026-04-14

About AXITINIB

AXITINIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Pfizer Laboratories Div Pfizer Inc. The most commonly reported adverse reactions for AXITINIB include DEATH, DIARRHOEA, FATIGUE, NEOPLASM PROGRESSION, HYPERTENSION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for AXITINIB.

Top Adverse Reactions

DEATH2,608 reports
DIARRHOEA2,550 reports
FATIGUE2,099 reports
NEOPLASM PROGRESSION1,323 reports
HYPERTENSION1,316 reports
DISEASE PROGRESSION1,208 reports
OFF LABEL USE1,178 reports
NAUSEA1,134 reports
DECREASED APPETITE1,075 reports
DYSPHONIA1,008 reports
BLOOD PRESSURE INCREASED841 reports
WEIGHT DECREASED794 reports
ASTHENIA755 reports
HEADACHE602 reports
STOMATITIS586 reports
VOMITING572 reports
MALAISE526 reports
CONSTIPATION516 reports
PAIN515 reports
DYSPNOEA511 reports
RASH476 reports
PAIN IN EXTREMITY451 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME444 reports
ARTHRALGIA439 reports
DEHYDRATION381 reports
RENAL CANCER354 reports
MALIGNANT NEOPLASM PROGRESSION336 reports
DIZZINESS333 reports
PRODUCT DOSE OMISSION ISSUE315 reports
HYPOTHYROIDISM308 reports
COUGH299 reports
PRURITUS292 reports
BLISTER283 reports
RENAL IMPAIRMENT276 reports
PNEUMONIA266 reports
ORAL PAIN257 reports
PYREXIA249 reports
ABDOMINAL PAIN243 reports
BACK PAIN242 reports
RENAL CELL CARCINOMA242 reports
ABDOMINAL PAIN UPPER241 reports
GAIT DISTURBANCE232 reports
DRY SKIN220 reports
FALL217 reports
ABDOMINAL DISCOMFORT215 reports
CONFUSIONAL STATE211 reports
DRY MOUTH210 reports
MYALGIA205 reports
METASTATIC RENAL CELL CARCINOMA204 reports
ACUTE KIDNEY INJURY190 reports
NEOPLASM MALIGNANT184 reports
APHONIA183 reports
DRUG INEFFECTIVE180 reports
GENERAL PHYSICAL HEALTH DETERIORATION179 reports
PROTEINURIA176 reports
FEELING ABNORMAL175 reports
CEREBROVASCULAR ACCIDENT169 reports
INSOMNIA168 reports
SOMNOLENCE167 reports
HEPATIC FUNCTION ABNORMAL165 reports
HYPOTENSION155 reports
PRODUCT USE IN UNAPPROVED INDICATION153 reports
OROPHARYNGEAL PAIN152 reports
DYSPHAGIA148 reports
ILLNESS148 reports
CHEST PAIN147 reports
BLOOD CREATININE INCREASED145 reports
PERIPHERAL SWELLING145 reports
GLOSSODYNIA144 reports
RENAL FAILURE143 reports
URINARY TRACT INFECTION142 reports
COVID 19140 reports
HEPATIC ENZYME INCREASED140 reports
ANAEMIA139 reports
EPISTAXIS138 reports
THERAPY INTERRUPTED138 reports
SKIN EXFOLIATION137 reports
MEMORY IMPAIRMENT134 reports
CONDITION AGGRAVATED132 reports
SEIZURE127 reports
MYOCARDIAL INFARCTION125 reports
SECOND PRIMARY MALIGNANCY125 reports
LIVER DISORDER116 reports
CARDIAC FAILURE113 reports
MUSCLE SPASMS112 reports
DYSGEUSIA110 reports
MUCOSAL INFLAMMATION110 reports
THROMBOSIS109 reports
DYSPEPSIA106 reports
HEPATOTOXICITY106 reports
INFECTION106 reports
MUSCULAR WEAKNESS106 reports
HAEMORRHAGE105 reports
PRODUCT USE ISSUE105 reports
THYROID DISORDER105 reports
ALANINE AMINOTRANSFERASE INCREASED104 reports
ERYTHEMA104 reports
THERAPY CESSATION103 reports
INTERSTITIAL LUNG DISEASE102 reports
HOSPITALISATION101 reports

Report Outcomes

Out of 18,985 classified reports for AXITINIB:

Serious 65.7%Non-Serious 34.3%

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

Male12,404 (70.5%)
Female5,117 (29.1%)
Unknown69 (0.4%)

Reports by Age

Age 65625 reports
Age 64594 reports
Age 70561 reports
Age 62559 reports
Age 66548 reports
Age 69532 reports
Age 68525 reports
Age 61524 reports
Age 71518 reports
Age 63516 reports
Age 72510 reports
Age 67509 reports
Age 60481 reports
Age 59458 reports
Age 73447 reports
Age 74440 reports
Age 75427 reports
Age 58419 reports
Age 57371 reports
Age 56344 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 AXITINIB?

This profile reflects 37,114 FDA FAERS reports that mention AXITINIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for AXITINIB?

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

Who manufactures AXITINIB?

Labeling and FAERS entries often list Pfizer Laboratories Div Pfizer Inc in connection with AXITINIB. 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.