Ferric Carboxymaltose side effects: what 4,631 FDA adverse event reports show
Drug class
Iron replacement product
Who reports
4,631 reports · 53% serious · 90 with death outcome · 84% female
Used for
Ferric carboxymaltose injection is indicated for the treatment of: • iron deficiency anemia (IDA) in: o adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. o adult patients who have non-dialysis dependent chronic kidney disease.
What it is
Ferric carboxymaltose, an iron replacement product, is an iron carbohydrate complex with the chemical name of polynuclear iron (III)-hydroxide 4(R)-(poly-(1→4)-O-α-D-glucopyranosyl)-oxy-2(R),3(R),5(R),6-tetrahydroxy-hexanoate.
Boxed warning
SYMPTOMATIC HYPOPHOSPHATEMIA • Ferric carboxymaltose injection can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention [see Warnings and Precautions (5.1) ] .
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 78 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Anhedonia | 254 | 43.8 38.9–49.4ROR 46.3 · χ² 10,497 / p <1e-300 | 43.3 EB05 39.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 52.5 · 94% clinician | no trial data cached |
| Infusion site pain | 37 | 13.2 9.5–18.1ROR 13.2 · χ² 402 / p 8e-90 | 12.8 EB05 9.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Product quality issue | 325 | 10.9 9.8–12.1ROR 11.7 · χ² 2,936 / p <1e-300 | 10.9 EB05 9.9 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 43.1 | no trial data cached |
| Blood iron decreased | 27 | 10.4 7.1–15.1ROR 10.4 · χ² 219 / p 6e-50 | 9.6 EB05 6.7 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.6 | no trial data cached |
| Injection site discolouration | 27 | 9.9 6.8–14.4ROR 9.9 · χ² 206 / p 4e-47 | 9.1 EB05 6.4 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious n=6 | no trial data cached |
| Emotional distress | 258 | 9.6 8.6–10.8ROR 10.1 · χ² 1,994 / p <1e-300 | 9.5 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · 93% clinician | no trial data cached |
| Skin discolouration | 96 | 9.5 7.8–11.6ROR 9.7 · χ² 719 / p 9e-159 | 9.2 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Ill-defined disorder | 117 | 8.7 7.3–10.4ROR 8.9 · χ² 794 / p 7e-175 | 8.5 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 126 | 8.6 7.3–10.3ROR 8.9 · χ² 846 / p 3e-186 | 8.5 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Urticaria (hives) | 287 | 7.8 7.0–8.7ROR 8.3 · χ² 1,710 / p <1e-300 | 7.7 EB05 7.0 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Flushing | 173 | 7.7 6.6–8.9ROR 7.9 · χ² 1,002 / p 4e-220 | 7.6 EB05 6.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Vitamin d deficiency | 16 | 7.4 4.6–12.1ROR 7.5 · χ² 83 / p 5e-20 | 6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.8 | no trial data cached |
| Throat tightness | 44 | 7.4 5.5–9.9ROR 7.4 · χ² 236 / p 1e-53 | 6.9 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Chest discomfort | 162 | 7.2 6.2–8.4ROR 7.4 · χ² 862 / p 1e-189 | 7.1 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 | no trial data cached |
| Hypocalcaemia (low calcium) | 28 | 6.7 4.6–9.7ROR 6.8 · χ² 131 / p 1e-30 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · ♀ 57% (drug 84%) · 100% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 78 | 6.4 5.2–8.0ROR 6.5 · χ² 353 / p 4e-79 | 6.2 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 | no trial data cached |
| Iron deficiency anaemia | 13 | 6.4 3.7–11.0ROR 6.4 · χ² 54 / p 1e-13 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 6.8 | no trial data cached |
| Throat irritation | 62 | 6.3 4.9–8.0ROR 6.4 · χ² 270 / p 4e-61 | 6.0 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Injection site extravasation | 17 | 6.2 3.8–9.9ROR 6.2 · χ² 69 / p 6e-17 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=3 | no trial data cached |
| Bone pain | 79 | 6.1 4.9–7.6ROR 6.2 · χ² 333 / p 1e-74 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 | no trial data cached |
| Myalgia (muscle pain) | 203 | 5.4 4.7–6.2ROR 5.6 · χ² 731 / p 3e-161 | 5.3 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Palpitations (pounding heartbeat) | 127 | 4.9 4.1–5.8ROR 5.0 · χ² 394 / p 5e-88 | 4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Presyncope (near-fainting) | 25 | 4.7 3.2–6.9ROR 4.7 · χ² 69 / p 6e-17 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Chest pain | 191 | 4.7 4.1–5.4ROR 4.8 · χ² 550 / p 6e-122 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 | no trial data cached |
| Anxiety | 292 | 4.6 4.1–5.2ROR 4.9 · χ² 840 / p 5e-185 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Adverse reaction | 13 | 4.4 2.6–7.6ROR 4.4 · χ² 31 / p 1e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious n=1 | no trial data cached |
| Paraesthesia oral | 14 | 4.4 2.6–7.4ROR 4.4 · χ² 34 / p 3e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Maternal exposure during pregnancy | 85 | 4.4 3.5–5.4ROR 4.4 · χ² 218 / p 1e-49 | 4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Dental caries | 10 | 4.1 2.2–7.6ROR 4.1 · χ² 20 / p 3e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Tachycardia (fast heart rate) | 77 | 3.9 3.1–4.9ROR 4.0 · χ² 166 / p 3e-38 | 3.8 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Stress | 60 | 3.8 2.9–4.9ROR 3.8 · χ² 120 / p 3e-28 | 3.7 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · 94% clinician | no trial data cached |
| Back pain | 187 | 3.6 3.2–4.2ROR 3.8 · χ² 360 / p 2e-80 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Muscle tightness | 13 | 3.6 2.1–6.3ROR 3.6 · χ² 22 / p 1e-6 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Premature delivery | 12 | 3.4 1.9–6.0ROR 3.4 · χ² 18 / p 1e-5 | 3.1 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Eye haemorrhage | 10 | 3.4 1.8–6.3ROR 3.4 · χ² 15 / p 7e-5 | 3.0 EB05 1.8 · IC025 +0.5 | Labeled (related wording) related wording | serious PRR 4.2 | no trial data cached |
| Dyspnoea exertional | 28 | 3.4 2.3–4.9ROR 3.4 · χ² 45 / p 1e-11 | 3.2 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 92% clinician | no trial data cached |
| Pain | 429 | 3.2 2.9–3.5ROR 3.4 · χ² 649 / p 2e-143 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.3 | no trial data cached |
| Nausea | 550 | 3.2 2.9–3.4ROR 3.4 · χ² 840 / p 6e-185 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Dyspnoea (shortness of breath) | 393 | 3.1 2.9–3.5ROR 3.3 · χ² 589 / p 2e-130 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Paraesthesia (tingling/numbness) | 109 | 3.1 2.6–3.8ROR 3.2 · χ² 157 / p 3e-36 | 3.1 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Nausea | 550 | 3.2 2.9–3.4ROR 3.4 · χ² 840 / p 6e-185 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Pain | 429 | 3.2 2.9–3.5ROR 3.4 · χ² 649 / p 2e-143 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.3 | no trial data cached |
| Dyspnoea (shortness of breath) | 393 | 3.1 2.9–3.5ROR 3.3 · χ² 589 / p 2e-130 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Headache | 365 | 2.6 2.4–2.9ROR 2.8 · χ² 381 / p 3e-85 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Product quality issue | 325 | 10.9 9.8–12.1ROR 11.7 · χ² 2,936 / p <1e-300 | 10.9 EB05 9.9 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 43.1 | no trial data cached |
| Dizziness | 308 | 2.8 2.5–3.1ROR 2.9 · χ² 363 / p 2e-81 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Anxiety | 292 | 4.6 4.1–5.2ROR 4.9 · χ² 840 / p 5e-185 | 4.6 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Urticaria (hives) | 287 | 7.8 7.0–8.7ROR 8.3 · χ² 1,710 / p <1e-300 | 7.7 EB05 7.0 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Arthralgia (joint pain) | 277 | 3.0 2.7–3.4ROR 3.2 · χ² 381 / p 3e-85 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 4.8 | no trial data cached |
| Emotional distress | 258 | 9.6 8.6–10.8ROR 10.1 · χ² 1,994 / p <1e-300 | 9.5 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · 93% clinician | no trial data cached |
| Anhedonia | 254 | 43.8 38.9–49.4ROR 46.3 · χ² 10,497 / p <1e-300 | 43.3 EB05 39.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 52.5 · 94% clinician | no trial data cached |
| Pruritus (itching) | 253 | 3.0 2.7–3.4ROR 3.1 · χ² 349 / p 4e-78 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Asthenia (weakness) | 215 | 2.6 2.3–3.0ROR 2.7 · χ² 212 / p 3e-48 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Rash | 203 | 2.1 1.9–2.4ROR 2.2 · χ² 121 / p 2e-28 | 2.1 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Myalgia (muscle pain) | 203 | 5.4 4.7–6.2ROR 5.6 · χ² 731 / p 3e-161 | 5.3 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Anhedonia — n=254, PRR 43.8
- Emotional distress — n=258, PRR 9.6
- Skin discolouration — n=96, PRR 9.5
- Ill-defined disorder — n=117, PRR 8.7
- Infusion related reaction — n=126, PRR 8.6
- Throat tightness — n=44, PRR 7.4
- Hypocalcaemia — n=28, PRR 6.7
- Throat irritation — n=62, PRR 6.3
- Myalgia — n=203, PRR 5.4
- Palpitations — n=127, PRR 4.9
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ferric Carboxymaltose?
In FDA FAERS, the most frequently co-reported reaction terms for Ferric Carboxymaltose are nausea, pain, dyspnoea, headache, dizziness, anxiety. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ferric Carboxymaltose have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SYMPTOMATIC HYPOPHOSPHATEMIA • Ferric carboxymaltose injection can cause severe, prolonged hypophosphatemia associated with serious outcomes, including hospitalization, osteomalacia and fractures requiring clinical intervention [see Warnings and Precautions (5.1) ] .
Do FAERS signals prove that Ferric Carboxymaltose causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 8e8e95f4-8d3a-4658-9f6c-09edf2210341, effective 20260815; matched on
openfda.generic_name.exact:"FERRIC CARBOXYMALTOSE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 118 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.