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Iron Side Effects

The most commonly reported side effects of iron include drug hypersensitivity, dyspnoea, and nausea, based on 11,647 FDA adverse event reports from 2004 to 2025. 3.2% of reports found the drug to be ineffective.

Iron side effects

Percentages show how often each reaction appears relative to total reports for iron.

1
Drug Hypersensitivity10.4%1,207
2
Dyspnoea9.1%1,055
3
Nausea8.7%1,011
4
Off Label Use6.5%757
5
Vomiting5.4%634
6
Pruritus5.2%600
7
Diarrhoea4.5%527
8
Rash4.3%502
9
Headache4.0%468
10
Dizziness3.9%452
11
Hypotension3.9%449
12
Infusion Related Reaction3.7%430
13
Urticaria3.7%430
14
Malaise3.6%425
15
Abdominal Pain3.6%420

These are voluntary reports and do not establish that iron caused these reactions.

Report severity

78.3%Serious9,115 reports
34.4%Hospitalizations4,012 reports
10.9%Fatal1,273 reports

Seriousness is determined by the reporter, not by OpenClaim.

Iron drug interactions

Other drugs that appear in adverse event reports alongside iron. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Methoxy-polyethylene-glycol-epoetin-beta12.8%1,489
2
Darbepoetin-alfa3.0%344
3
Infliximab2.1%248
4
Heparin1.9%226
5
Dextrose1.9%220
6
Lansoprazole1.8%214
7
Methotrexate1.8%210
8
Sodium-chloride1.6%186
9
Adalimumab1.6%185
10
Acetaminophen1.6%185
11
Pantoprazole-sodium1.5%180
12
Ceftriaxone-sodium1.5%176
13
Vedolizumab1.4%168
14
Prednisone1.3%155
15
Omeprazole1.3%154

Taken alongside

1
Acetaminophen10.7%1,252
2
Furosemide8.5%993
3
Ergocalciferol8.4%978
4
Aspirin8.1%940
5
Amlodipine7.3%851
6
Omeprazole7.2%837
7
Prednisone6.6%769
8
Pantoprazole-sodium6.1%708
9
Folic-acid5.8%672
10
Insulin5.6%647
11
Levothyroxine-sodium5.5%644
12
Metoprolol5.2%611
13
Sevelamer5.0%579
14
Atorvastatin-calcium4.9%569
15
Calcitriol4.8%562

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports iron side effects

60.2% of iron adverse event reports involve female patients and 31.1% involve male patients. The largest age group is adult at 61%. These figures reflect who reports side effects, not underlying risk.

Sex

Female60.2%
Male31.1%
Unknown8.7%

Age group

< 21.3%
2–111.5%
12–171.9%
18–6460.8%
65+34.6%

What is iron used for

Conditions and purposes for which patients were taking iron when the adverse event was reported.

AbscessAccidental ExposureAcute Myeloid LeukaemiaAdverse EventAlopeciaAnaemiaAnaemia Haemolytic AutoimmuneAnaemia MegaloblasticAnaemia Of Chronic DiseaseAnaemia Of Malignant DiseaseAnaemia Of PregnancyAnaemia PostoperativeAnaemia ProphylaxisAnemiaAnemia, Postpartum

Showing 15 of 333 indications

Iron brand names and reporting trend

Iron is sold under brand names including Iron Sucrose, Proferdex.

Brand names

Iron Sucrose2,069
Proferdex1,027

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking iron with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.