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What the label lists and what reports show

Ferric derisomaltose side effects

Ferric derisomaltose's FDA label: “Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea.” FAERS holds 1,305 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (275 reports).

  • No generic listed

Check it at the source: the ferric derisomaltose FDA label on DailyMed (effective November 25, 2025, Pharmacosmos Therapeutics Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of MONOFERRIC?

MONOFERRIC may cause serious side effects, including: Allergic (hypersensitivity) reactions. Serious life-threatening allergic reactions have happened in people who receive MONOFERRIC. Symptoms of an allergic reaction including rash, itching, hives, dizziness, lightheadedness, breathing problems and low blood pressure have also happened during treatment with MONOFERRIC. Tell your healthcare provider right away if you develop any of the above symptoms of a serious allergic reaction or if you have ever had any unusual or allergic reaction to any IV iron in the past. Too much iron stored in your body (iron overload). Your healthcare provider should check the iron level in your blood before you start and during treatment with MONOFERRIC. The most common side effects of MONOFERRIC include rash and nausea. These are not all the possible side effects of MONOFERRIC. […]

Source: FDA drug label, Pharmacosmos Therapeutics Inc., effective November 25, 2025 (SPL set 55859d2d-0456-4fa9-b41f-f535accc97db), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea.

From the label: adverse reactions, continued

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions (see Warnings and Precautions (5.1) ). Iron Overload (see Warnings and Precautions (5.2) ). Most commonly reported adverse reactions (incidence ≥1%) are rash and nausea. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pharmacosmos at 1-888-828-0655 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. The safety of Monoferric was evaluated in 3008 patients with iron deficiency anemia enrolled in two randomized, actively-controlled trials. Trial 1 enrolled adult patients with iron deficiency anemia with intolerance to oral iron or had an unsatisfactory response to oral iron with a clinical need for repletion of iron stores. Eligible subjects were required to have a baseline hemoglobin of ≤11g/dl, transferrin saturation (TSAT) of less than 20% and serum ferritin level of <100 ng/mL. Trial 2 enrolled adult patients with non-dialysis dependent chronic kidney disease (CKD) with iron deficiency anemia ( see Clinical Studies (14) ). …

Source: FDA drug label, Pharmacosmos Therapeutics Inc., effective November 25, 2025 (SPL set 55859d2d-0456-4fa9-b41f-f535accc97db), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,305 reports list ferric derisomaltose among the medicines taken, each a report of something that happened, not proof the medicine caused it; 46 are coded as a death and 219 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 18 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Ferric derisomaltose: the full record
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Side effects hub
the most reported medicines and reactions