IRON SUCROSE

N/A

Manufactured by American Regent, Inc.

23,285 FDA adverse event reports analyzed

Last updated: 2026-04-14

About IRON SUCROSE

IRON SUCROSE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by American Regent, Inc.. The most commonly reported adverse reactions for IRON SUCROSE include DRUG HYPERSENSITIVITY, NAUSEA, DYSPNOEA, OFF LABEL USE, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for IRON SUCROSE.

Top Adverse Reactions

DRUG HYPERSENSITIVITY1,135 reports
NAUSEA948 reports
DYSPNOEA943 reports
OFF LABEL USE603 reports
VOMITING590 reports
PRURITUS582 reports
DIARRHOEA516 reports
RASH495 reports
HYPOTENSION483 reports
DIZZINESS456 reports
MALAISE435 reports
HEADACHE431 reports
ARTHRALGIA419 reports
PAIN408 reports
URTICARIA404 reports
INFUSION RELATED REACTION382 reports
ABDOMINAL PAIN361 reports
DRUG INEFFECTIVE336 reports
HYPERSENSITIVITY331 reports
FATIGUE329 reports
HYPERTENSION320 reports
PERIPHERAL SWELLING319 reports
ERYTHEMA303 reports
BACK PAIN300 reports
PYREXIA282 reports
DEATH279 reports
ASTHENIA275 reports
ANAEMIA273 reports
CHEST PAIN273 reports
COUGH268 reports
PARAESTHESIA268 reports
FLUSHING246 reports
OEDEMA PERIPHERAL238 reports
HYPERHIDROSIS236 reports
ABDOMINAL PAIN UPPER228 reports
PAIN IN EXTREMITY216 reports
CHEST DISCOMFORT209 reports
ABDOMINAL DISCOMFORT196 reports
BLOOD PRESSURE DECREASED196 reports
LOSS OF CONSCIOUSNESS195 reports
TACHYCARDIA191 reports
HAEMOGLOBIN DECREASED186 reports
CONDITION AGGRAVATED185 reports
FEELING HOT184 reports
BURNING SENSATION181 reports
CHILLS180 reports
MATERNAL EXPOSURE DURING PREGNANCY176 reports
PNEUMONIA175 reports
PRODUCT QUALITY ISSUE171 reports
BLOOD PRESSURE INCREASED168 reports
SYNCOPE168 reports
UNRESPONSIVE TO STIMULI168 reports
PRODUCT USE ISSUE166 reports
CARDIAC FAILURE CONGESTIVE162 reports
ANAPHYLACTIC REACTION156 reports
ANXIETY151 reports
EXTRAVASATION148 reports
CONTRAINDICATED PRODUCT ADMINISTERED143 reports
DRUG INTOLERANCE142 reports
THERAPEUTIC PRODUCT EFFECT DECREASED142 reports
JOINT SWELLING141 reports
RENAL FAILURE134 reports
CARDIAC ARREST128 reports
CARDIAC FAILURE126 reports
HEPATIC STEATOSIS126 reports
HYPOAESTHESIA126 reports
SKIN DISCOLOURATION126 reports
HEART RATE INCREASED125 reports
PRODUCT USE IN UNAPPROVED INDICATION124 reports
ACUTE KIDNEY INJURY123 reports
FALL121 reports
MUSCLE SPASMS121 reports
WEIGHT DECREASED118 reports
TREMOR115 reports
DECREASED APPETITE114 reports
INCORRECT PRODUCT ADMINISTRATION DURATION113 reports
CHRONIC KIDNEY DISEASE110 reports
HEPATIC ENZYME INCREASED110 reports
MYALGIA109 reports
END STAGE RENAL DISEASE107 reports
MUSCULOSKELETAL STIFFNESS107 reports
FEELING ABNORMAL105 reports
PALLOR104 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION99 reports
INSOMNIA98 reports
SEPSIS97 reports
THERAPEUTIC RESPONSE DECREASED96 reports
GASTROINTESTINAL DISORDER95 reports
PALPITATIONS94 reports
ATRIAL FIBRILLATION91 reports
EXPOSURE DURING PREGNANCY91 reports
CONFUSIONAL STATE89 reports
NEPHROGENIC SYSTEMIC FIBROSIS88 reports
SWELLING88 reports
LOSS OF EMPLOYMENT86 reports
RESPIRATORY DISTRESS84 reports
THROMBOCYTOPENIA83 reports
CONSTIPATION75 reports
INFUSION SITE PAIN74 reports
INJECTION SITE PAIN74 reports

Report Outcomes

Out of 9,002 classified reports for IRON SUCROSE:

Serious 78.7%Non-Serious 21.3%

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

Female5,528 (66.4%)
Male2,771 (33.3%)
Unknown24 (0.3%)

Reports by Age

Age 47177 reports
Age 50157 reports
Age 63143 reports
Age 76136 reports
Age 72135 reports
Age 65132 reports
Age 66132 reports
Age 42124 reports
Age 64119 reports
Age 46117 reports
Age 60113 reports
Age 70113 reports
Age 55110 reports
Age 44109 reports
Age 48109 reports
Age 58107 reports
Age 51104 reports
Age 43103 reports
Age 56102 reports
Age 62102 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 IRON SUCROSE?

This profile reflects 23,285 FDA FAERS reports that mention IRON SUCROSE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for IRON SUCROSE?

Frequently reported terms in FAERS include DRUG HYPERSENSITIVITY, NAUSEA, DYSPNOEA, OFF LABEL USE, VOMITING, PRURITUS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures IRON SUCROSE?

Labeling and FAERS entries often list American Regent, Inc. in connection with IRON SUCROSE. 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.