Drug · FAERS side-effect profile with label screen
Ferric Derisomaltose side effects: what 1,305 FDA adverse event reports show
Drug class
Iron replacement product
FDA label, Indications wording
Brand names
Monoferric
openFDA label
Who reports
1,305 reports · 53% serious · 46 with death outcome · 77% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Monoferric is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: who have intolerance to oral iron or have had unsatisfactory response to oral iron who have non-hemodialysis dependent chronic kidney disease (NDD-CKD) MONOFER.
FDA label, Indications and Usage
What it is
Monoferric is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 36 strongest signals
Labeled adverse reaction 4Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 22
What the badges mean
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 12 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Appendicitis | 18 | 31.2 19.7–49.3ROR 31.6 · χ² 495 / p 5e-110 | 30.2 EB05 20.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 34.3 | no trial data cached |
| Ventricular fibrillation | 19 | 27.5 17.6–42.9ROR 27.8 · χ² 458 / p 8e-102 | 26.8 EB05 18.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 29.9 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 102 | 24.8 20.6–29.9ROR 26.9 · χ² 2,315 / p <1e-300 | 24.7 EB05 20.9 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.0 | no trial data cached |
| Flushing | 149 | 23.5 20.2–27.3ROR 26.4 · χ² 3,195 / p <1e-300 | 23.4 EB05 20.4 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.9 · 97% clinician | no trial data cached |
| Chest discomfort | 141 | 22.2 19.0–26.0ROR 24.8 · χ² 2,849 / p <1e-300 | 22.2 EB05 19.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 19.2 · 93% clinician | no trial data cached |
| Cardiogenic shock | 19 | 21.4 13.7–33.5ROR 21.7 · χ² 349 / p 3e-78 | 20.9 EB05 14.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 23.2 | no trial data cached |
| Incorrect route of product administration | 21 | 20.1 13.1–30.7ROR 20.4 · χ² 362 / p 5e-81 | 19.7 EB05 13.5 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 43.6 · ♀ 0% (drug 77%) · 100% clinician | no trial data cached |
| Unresponsive to stimuli | 32 | 20.0 14.2–28.2ROR 20.5 · χ² 559 / p 7e-124 | 19.8 EB05 14.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 22.2 · 97% clinician | no trial data cached |
| Iron deficiency anaemia | 11 | 19.3 10.7–34.7ROR 19.4 · χ² 172 / p 1e-39 | 18.2 EB05 10.0 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 22.2 | no trial data cached |
| Oxygen saturation decreased | 61 | 17.6 13.8–22.5ROR 18.4 · χ² 939 / p 2e-206 | 17.5 EB05 14.1 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 14.8 · 98% clinician | no trial data cached |
| Hyperlipidaemia | 13 | 17.4 10.2–30.0ROR 17.6 · χ² 185 / p 2e-42 | 16.5 EB05 9.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.9 | no trial data cached |
| Ulcer | 16 | 16.2 9.9–26.3ROR 16.3 · χ² 212 / p 2e-48 | 15.4 EB05 9.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 22.1 | no trial data cached |
| Blood test abnormal | 14 | 16.0 9.5–27.0ROR 16.2 · χ² 183 / p 7e-42 | 15.1 EB05 8.9 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 26.7 | no trial data cached |
| Throat tightness | 26 | 15.5 10.6–22.7ROR 15.8 · χ² 338 / p 9e-76 | 15.1 EB05 10.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 49 | 14.3 10.9–18.9ROR 14.9 · χ² 596 / p 6e-132 | 14.2 EB05 11.0 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.9 · 94% clinician | no trial data cached |
| End stage renal disease | 16 | 14.0 8.6–22.7ROR 14.1 · χ² 180 / p 3e-41 | 13.0 EB05 7.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 | no trial data cached |
| Neuralgia | 20 | 13.3 8.6–20.5ROR 13.5 · χ² 215 / p 7e-49 | 12.5 EB05 8.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 21.4 | no trial data cached |
| Bacterial infection | 15 | 13.0 7.9–21.5ROR 13.1 · χ² 154 / p 1e-35 | 11.8 EB05 7.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.3 | no trial data cached |
| Gout | 14 | 12.5 7.4–21.1ROR 12.7 · χ² 137 / p 5e-32 | 11.2 EB05 6.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 20.6 | no trial data cached |
| Throat irritation | 32 | 11.5 8.2–16.2ROR 11.8 · χ² 297 / p 7e-67 | 11.0 EB05 7.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · 90% clinician | no trial data cached |
| Skin reaction | 10 | 11.4 6.2–21.2ROR 11.5 · χ² 85 / p 1e-20 | 9.3 EB05 4.8 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.1 | no trial data cached |
| Feeling hot | 43 | 11.3 8.4–15.1ROR 11.6 · χ² 393 / p 1e-87 | 10.9 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 19 | 10.9 7.0–17.1ROR 11.1 · χ² 162 / p 2e-37 | 9.9 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 | no trial data cached |
| Maternal exposure during pregnancy | 57 | 10.4 8.1–13.4ROR 10.8 · χ² 476 / p 8e-106 | 10.1 EB05 7.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Ascites | 18 | 9.8 6.2–15.6ROR 10.0 · χ² 134 / p 2e-31 | 8.7 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Blood pressure decreased | 38 | 9.2 6.7–12.6ROR 9.5 · χ² 271 / p 4e-61 | 8.7 EB05 6.5 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.4 · 92% clinician | no trial data cached |
| Product administration error | 11 | 8.9 4.9–16.0ROR 8.9 · χ² 69 / p 5e-17 | 7.1 EB05 4.0 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Pallor | 15 | 8.8 5.3–14.6ROR 8.9 · χ² 97 / p 4e-23 | 7.5 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Hepatic cirrhosis | 10 | 8.6 4.6–15.9ROR 8.7 · χ² 60 / p 5e-15 | 6.7 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Back pain | 120 | 8.3 7.0–9.8ROR 9.0 · χ² 771 / p 5e-170 | 8.1 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 91% clinician | no trial data cached |
| Dyspnoea (shortness of breath) | 275 | 7.8 7.0–8.7ROR 9.6 · χ² 1,672 / p <1e-300 | 7.7 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 94% clinician | no trial data cached |
| Hyperhidrosis (excessive sweating) | 60 | 7.5 5.8–9.6ROR 7.8 · χ² 332 / p 2e-74 | 7.1 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 92% clinician | no trial data cached |
| Frequent bowel movements | 12 | 7.2 4.1–12.6ROR 7.2 · χ² 58 / p 2e-14 | 5.8 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Loss of consciousness | 53 | 6.6 5.1–8.6ROR 6.9 · χ² 250 / p 1e-56 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · 94% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 20 | 6.2 4.0–9.5ROR 6.2 · χ² 82 / p 8e-20 | 5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · 90% clinician | no trial data cached |
| Colitis ulcerative | 13 | 4.7 2.7–8.0ROR 4.7 · χ² 34 / p 3e-9 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 275 | 7.8 7.0–8.7ROR 9.6 · χ² 1,672 / p <1e-300 | 7.7 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 · 94% clinician | no trial data cached |
| Flushing | 149 | 23.5 20.2–27.3ROR 26.4 · χ² 3,195 / p <1e-300 | 23.4 EB05 20.4 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.9 · 97% clinician | no trial data cached |
| Chest discomfort | 141 | 22.2 19.0–26.0ROR 24.8 · χ² 2,849 / p <1e-300 | 22.2 EB05 19.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 19.2 · 93% clinician | no trial data cached |
| Back pain | 120 | 8.3 7.0–9.8ROR 9.0 · χ² 771 / p 5e-170 | 8.1 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 · 91% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 102 | 24.8 20.6–29.9ROR 26.9 · χ² 2,315 / p <1e-300 | 24.7 EB05 20.9 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 28.0 | no trial data cached |
| Oxygen saturation decreased | 61 | 17.6 13.8–22.5ROR 18.4 · χ² 939 / p 2e-206 | 17.5 EB05 14.1 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 14.8 · 98% clinician | no trial data cached |
| Hyperhidrosis (excessive sweating) | 60 | 7.5 5.8–9.6ROR 7.8 · χ² 332 / p 2e-74 | 7.1 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 92% clinician | no trial data cached |
| Maternal exposure during pregnancy | 57 | 10.4 8.1–13.4ROR 10.8 · χ² 476 / p 8e-106 | 10.1 EB05 7.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.1 · ♀ 100% (drug 77%) · 95% clinician | no trial data cached |
| Loss of consciousness | 53 | 6.6 5.1–8.6ROR 6.9 · χ² 250 / p 1e-56 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · 94% clinician | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 49 | 14.3 10.9–18.9ROR 14.9 · χ² 596 / p 6e-132 | 14.2 EB05 11.0 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.9 · 94% clinician | no trial data cached |
| Feeling hot | 43 | 11.3 8.4–15.1ROR 11.6 · χ² 393 / p 1e-87 | 10.9 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 · 95% clinician | no trial data cached |
| Blood pressure decreased | 38 | 9.2 6.7–12.6ROR 9.5 · χ² 271 / p 4e-61 | 8.7 EB05 6.5 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.4 · 92% clinician | no trial data cached |
| Throat irritation | 32 | 11.5 8.2–16.2ROR 11.8 · χ² 297 / p 7e-67 | 11.0 EB05 7.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · 90% clinician | no trial data cached |
| Unresponsive to stimuli | 32 | 20.0 14.2–28.2ROR 20.5 · χ² 559 / p 7e-124 | 19.8 EB05 14.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 22.2 · 97% clinician | no trial data cached |
| Throat tightness | 26 | 15.5 10.6–22.7ROR 15.8 · χ² 338 / p 9e-76 | 15.1 EB05 10.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | 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.
- Chest discomfort — n=141, PRR 22.2
- Unresponsive to stimuli — n=32, PRR 20.0
- Throat tightness — n=26, PRR 15.5
- Neuralgia — n=20, PRR 13.3
- Throat irritation — n=32, PRR 11.5
- Feeling hot — n=43, PRR 11.3
- Hyperhidrosis — n=60, PRR 7.5
- Chronic obstructive pulmonary disease — n=20, PRR 6.2
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 Derisomaltose?
In FDA FAERS, the most frequently co-reported reaction terms for Ferric Derisomaltose are dyspnoea, flushing, chest discomfort, back pain, infusion related reaction, oxygen saturation decreased. 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 Derisomaltose have an FDA boxed warning?
No. The FDA label retrieved for Ferric Derisomaltose has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ferric Derisomaltose 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 55859d2d-0456-4fa9-b41f-f535accc97db, effective 20251125; matched on
openfda.generic_name.exact:"FERRIC DERISOMALTOSE") - 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, 48 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.