DEFERASIROX

N/A

Manufactured by Novartis Pharmaceuticals Corporation

50,952 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DEFERASIROX

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

Top Adverse Reactions

DEATH4,694 reports
DIARRHOEA2,335 reports
SICKLE CELL ANAEMIA WITH CRISIS1,803 reports
PYREXIA1,464 reports
NAUSEA1,415 reports
HAEMOGLOBIN DECREASED1,406 reports
PNEUMONIA1,246 reports
SERUM FERRITIN INCREASED1,174 reports
MALAISE1,124 reports
FATIGUE1,119 reports
VOMITING1,095 reports
ABDOMINAL PAIN904 reports
PAIN898 reports
BLOOD CREATININE INCREASED829 reports
PLATELET COUNT DECREASED820 reports
ANAEMIA801 reports
ASTHENIA799 reports
DYSPNOEA786 reports
ABDOMINAL PAIN UPPER670 reports
HEADACHE654 reports
RASH627 reports
WEIGHT DECREASED565 reports
RENAL FAILURE552 reports
SEPSIS544 reports
DRUG INEFFECTIVE535 reports
INFECTION511 reports
DIZZINESS505 reports
OFF LABEL USE505 reports
ABDOMINAL DISCOMFORT503 reports
DECREASED APPETITE481 reports
MYELODYSPLASTIC SYNDROME470 reports
WHITE BLOOD CELL COUNT DECREASED468 reports
THROMBOCYTOPENIA466 reports
BACK PAIN433 reports
RENAL IMPAIRMENT431 reports
FALL427 reports
PAIN IN EXTREMITY407 reports
BLOOD IRON INCREASED401 reports
URINARY TRACT INFECTION398 reports
ALANINE AMINOTRANSFERASE INCREASED389 reports
CONSTIPATION387 reports
ARTHRALGIA379 reports
RENAL DISORDER379 reports
ASPARTATE AMINOTRANSFERASE INCREASED373 reports
DEHYDRATION359 reports
DISEASE PROGRESSION353 reports
COUGH348 reports
CHEST PAIN337 reports
PRURITUS334 reports
OEDEMA PERIPHERAL333 reports
GENERAL PHYSICAL HEALTH DETERIORATION325 reports
BLOOD BILIRUBIN INCREASED318 reports
BLOOD UREA INCREASED308 reports
PANCYTOPENIA306 reports
HAEMATOCRIT DECREASED299 reports
LIVER DISORDER297 reports
NEOPLASM MALIGNANT291 reports
ACUTE MYELOID LEUKAEMIA290 reports
DRUG DOSE OMISSION285 reports
NEUTROPENIA285 reports
CEREBROVASCULAR ACCIDENT274 reports
ABDOMINAL DISTENSION271 reports
IRON OVERLOAD269 reports
HEPATIC ENZYME INCREASED261 reports
HOSPITALISATION260 reports
FEBRILE NEUTROPENIA257 reports
DRUG INTOLERANCE255 reports
INFLUENZA254 reports
WHITE BLOOD CELL COUNT INCREASED252 reports
CONDITION AGGRAVATED248 reports
RED BLOOD CELL COUNT DECREASED248 reports
MALIGNANT NEOPLASM PROGRESSION245 reports
HYPOTENSION239 reports
SPLENOMEGALY231 reports
CARDIAC FAILURE230 reports
LIVER FUNCTION TEST ABNORMAL220 reports
NEPHROLITHIASIS220 reports
GASTROINTESTINAL HAEMORRHAGE219 reports
RENAL FAILURE ACUTE219 reports
WEIGHT INCREASED218 reports
FEELING ABNORMAL217 reports
CARDIAC FAILURE CONGESTIVE212 reports
NEUTROPHIL COUNT DECREASED207 reports
CHILLS205 reports
PRODUCT DOSE OMISSION ISSUE205 reports
NASOPHARYNGITIS202 reports
GASTROINTESTINAL DISORDER197 reports
CONFUSIONAL STATE195 reports
JAUNDICE193 reports
GAIT DISTURBANCE190 reports
PLEURAL EFFUSION187 reports
HAEMORRHAGE185 reports
LEUKAEMIA183 reports
BLOOD GLUCOSE INCREASED180 reports
CHROMATURIA179 reports
DYSPEPSIA179 reports
HEPATIC FAILURE179 reports
BLOOD ALKALINE PHOSPHATASE INCREASED178 reports
BLOOD LACTATE DEHYDROGENASE INCREASED176 reports
SEPTIC SHOCK173 reports

Report Outcomes

Out of 26,183 classified reports for DEFERASIROX:

Serious 86.6%Non-Serious 13.4%

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

Male12,087 (50.7%)
Female11,689 (49.0%)
Unknown75 (0.3%)

Reports by Age

Age 70293 reports
Age 74268 reports
Age 75263 reports
Age 78254 reports
Age 73253 reports
Age 76253 reports
Age 72248 reports
Age 79245 reports
Age 80239 reports
Age 77235 reports
Age 69232 reports
Age 68222 reports
Age 81209 reports
Age 82205 reports
Age 71199 reports
Age 65190 reports
Age 67183 reports
Age 83169 reports
Age 66167 reports
Age 64152 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 DEFERASIROX?

This profile reflects 50,952 FDA FAERS reports that mention DEFERASIROX. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DEFERASIROX?

Frequently reported terms in FAERS include DEATH, DIARRHOEA, SICKLE CELL ANAEMIA WITH CRISIS, PYREXIA, NAUSEA, HAEMOGLOBIN DECREASED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DEFERASIROX?

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