Ferric Derisomaltose: uses, dosing, side effects & brands
Ferric Derisomaltose is a medicine sold in the U.S. under one brand, for iron-deficiency anemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Iron-Deficiency Anemia
- Available as
- Injectable
- Sold as
- Monoferric
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How ferric derisomaltose is dosed
From the FDA label for Monoferric (application NDA208171). Other ferric derisomaltose products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric as an intravenous infusion. For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight as an intravenous infusion. Repeat Monoferric treatment if iron deficiency anemia reoccurs. ( 2 ) 2.1 Recommended Dosage For patients weighing 50 kg or more: Administer 1,000 mg of Monoferric by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs. For patients weighing less than 50 kg: Administer Monoferric as 20 mg/kg actual body weight by intravenous infusion over at least 20 minutes as a single dose. Repeat dose if iron deficiency anemia reoccurs. The dosage of Monoferric is expressed in mg of elemental iron. Each mL of Monoferric contains 100 mg of elemental iron. Only administer Monoferric when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions ( Warnings and Precautions (5.1) ) . 2.2 Preparation and Administration Inspect parenteral drug products visually for the absence of particulate matter and discoloration prior to administration. The product contains no preservatives. Each vial of Monoferric is single-dose only. Discard unused portion. Withdraw the appropriate volume of Monoferric and dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP. Final diluted…
Ferric Derisomaltose side effects
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) ). Eligible subjects also had to have serum…
Who shouldn’t take ferric derisomaltose
Monoferric is contraindicated in patients with a history of serious hypersensitivity to Monoferric or any of its components (see Warnings and Precautions (5.1) , Description (11) ) . Reactions have included shock, clinically significant hypotension, loss of consciousness, and/or collapse. Serious hypersensitivity to Monoferric or any of its components. ( 4 )
Every ferric derisomaltose product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Monoferric.
Ferric Derisomaltose and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for ferric derisomaltose: levels in milk, effects in breastfed infants, and the drugs it would consider insteadLimited data indicate that breastmilk iron is increased 3 days after an intravenous infusion of ferric derisomaltose (formerly called iron isomaltoside), but levels remain within the normal range. By 7 days after the dose, breastmilk iron levels were similar to that of mothers taking oral iron. Ferric derisomaltose appears to be acceptable to use in nursing mothers with no special precautions required. For additional information on iron use during breastfeeding, see the monograph on Iron Salts.
National Institute of Child Health and Human Development, record revised March 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about ferric derisomaltose
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 122 reports naming ferric derisomaltose, and the FDA flagged 88% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- dyspnoea17 reports
- infusion related reaction16 reports
- nausea14 reports
- vomiting11 reports
- fatigue10 reports
- abdominal pain9 reports
- back pain9 reports
- palpitations9 reports
Read these as a signal, not a rate. A report does not mean ferric derisomaltose caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is ferric derisomaltose?
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.
Can you take ferric derisomaltose with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ferric derisomaltose against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does ferric derisomaltose come in?
Across the brands we track, ferric derisomaltose is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ferric derisomaltose?
We do not currently list a generic-labelled ferric derisomaltose product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Ferric Derisomaltose: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ferric-derisomaltose
- MLA
- “Ferric Derisomaltose: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ferric-derisomaltose.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for ferric derisomaltose on DailyMed (NIH) ↗.