What the label lists and what reports show
Ferric carboxymaltose side effects
Ferric carboxymaltose's FDA label: “The most common adverse reactions in adult patients (>2%) are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness.” FAERS holds 4,632 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 hypophosphataemia (843 reports).
- Generic listed
- Boxed warning
Check it at the source: the ferric carboxymaltose FDA label on DailyMed (effective August 19, 2026, American Regent, 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 INJECTAFER?INJECTAFER can cause serious side effects, including: See “What is the most important information I should know about INJECTAFER?” Allergic reactions. Serious life-threatening allergic reactions that can lead to death have happened in people who receive INJECTAFER. Your healthcare provider will watch you during and for at least 30 minutes after you receive INJECTAFER. Tell your healthcare provider right away if you develop any of the following signs or symptoms of allergic reactions during or after treatment with INJECTAFER: low blood pressure feeling dizzy or lightheaded loss of consciousness trouble breathing swelling fast heartbeat cold or clammy skin feet or hands turn blue itching rash hives wheezing • High blood pressure. High blood pressure, sometimes with redness and warmth of the face (facial flushing), dizziness, or nausea, has happened during treatment with INJECTAFER. […]
Source: FDA drug label, American Regent, Inc., effective August 19, 2026 (SPL set 517b4a19-45b3-4286-9f6a-ced4e10447de), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions in adult patients (>2%) are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | Injectafer 15 mg/kg to a maximum of 750 mg x 2 doses to a cumulative dose of 1,500 mg IVIT09030 and IVIT09031 b (N=1,775) % | Injectafer 15 mg/kg to a maximum of 1,000 mg single dose IVIT07017 and IVIT07018 a (N=1,200) % |
|---|---|---|
| Any Adverse Reaction | 24 | 12 |
| Injection site reactions | 3 | 4 |
| Injection site extravasation | 0.2 | 2 |
| Hepatic enzyme increased | 1.2 | 1.2 |
| Rash | 1 | 1.2 |
| Headache | 1.3 | 1 |
| Dizziness | 2.1 | 1 |
| Dysgeusia | 1.2 | 1 |
| Nausea | 7.2 | 1 |
| Hypertension | 4 | 1 |
| Hypophosphatemia | 2.1 | 1 |
| Erythema | 3 | 0.3 |
| Flushing | 4 | 0.3 |
| Vomiting | 2 | 0.2 |
| Injection site discoloration | 1.4 | <0.1 |
| Hypotension | 1 | <0.1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Symptomatic Hypophosphatemia [see Warnings and Precautions ( 5.1 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Laboratory Test Alterations [see Warnings and Precautions ( 5.4 )] The most common adverse reactions in adult patients (>2%) are nausea, hypertension, flushing, injection site reactions, erythema, hypophosphatemia, and dizziness. ( 6.1 ) The most common adverse reactions in pediatric patients (≥4%) are hypophosphatemia, injection site reactions, rash, headache, and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact American Regent at 1-800-734-9236 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. Adults In two randomized clinical studies [Studies 1 and 2, see Clinical Studies ( 14 ) ], a total of 1,775 patients were exposed to Injectafer 15 mg/kg body weight up to a maximum single dose of 750 mg of iron on two occasions separated by at least 7 days up to a cumulative dose of 1,500 mg of iron. …
Source: FDA drug label, American Regent, Inc., effective August 19, 2026 (SPL set 517b4a19-45b3-4286-9f6a-ced4e10447de), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,632 reports list ferric carboxymaltose among the medicines taken, each a report of something that happened, not proof the medicine caused it; 90 are coded as a death and 607 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 24 reactions below, 14 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 carboxymaltose: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions