What the label lists and what reports show
Ferumoxytol side effects
Ferumoxytol's FDA label: “The most common adverse reactions (≥0.65%) are nausea, pruritus, constipation, headache, diarrhea, increased blood pressure, bleeding, hyperpigmentation, vein injury, taste alteration, burning/tingling sensation with injection, red sclera, allergic rhinitis …” FAERS holds 1,902 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 (462 reports).
- Generic listed
- Boxed warning
Check it at the source: the ferumoxytol FDA label on DailyMed (effective October 14, 2025, Azurity Pharmaceuticals, 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 FERABRIGHT?FERABRIGHT can cause serious side effects, including: See “What is the most important information I should know about FERABRIGHT?” Low blood pressure (hypotension) is a side effect of FERABRIGHT that can sometimes be serious. Your healthcare provider will check you for signs and symptoms of hypotension after each FERABRIGHT infusion. Report the following symptoms immediately to your healthcare provider: feeling dizzy or lightheaded feeling faint or fainting (syncope) blurred vision trouble concentrating or confused feeling weak, tired, or sleepy upset stomach or vomiting Iron overload. FERABRIGHT can cause too much iron storage in your body. MRI Test Interference. Tell your healthcare provider if you have any MRIs, other than your brain scan, scheduled in the next 3 months after you receive FERABRIGHT, because it may affect the test results. […]
Source: FDA drug label, Azurity Pharmaceuticals, Inc., effective October 14, 2025 (SPL set ac666008-a14f-43b4-9d06-ec70f45a4234), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥0.65%) are nausea, pruritus, constipation, headache, diarrhea, increased blood pressure, bleeding, hyperpigmentation, vein injury, taste alteration, burning/tingling sensation with injection, red sclera, allergic rhinitis, back pain, vomiting, and increased ALT.
Table 2: Adverse Reactions to Feraheme Reported in ≥1% of Patients with IDA and CKD…
This table is printed in the Feraheme label published by AMAG Pharmaceuticals, Inc of May 31, 2026; the label quoted above does not print one.
| Adverse Reactions | Feraheme 2 x 510 mg (n = 605) % | Oral Iron (n = 280) % |
|---|---|---|
| Nausea | 3.1 | 7.5 |
| Dizziness | 2.6 | 1.8 |
| Hypotension | 2.5 | 0.4 |
| Peripheral Edema | 2 | 3.2 |
| Headache | 1.8 | 2.1 |
| Edema | 1.5 | 1.4 |
| Vomiting | 1.5 | 5 |
| Abdominal Pain | 1.3 | 1.4 |
| Chest Pain | 1.3 | 0.7 |
| Cough | 1.3 | 1.4 |
| Pruritus | 1.2 | 0.4 |
| Pyrexia | 1 | 0.7 |
| Back Pain | 1 | 0 |
| Muscle Spasms | 1 | 1.4 |
| Dyspnea | 1 | 1.1 |
| Rash | 1 | 0.4 |
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 described elsewhere in the labeling: Anaphylaxis and Other Serious Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Hypotension [see Warnings and Precautions ( 5.2 )] The most common adverse reactions (≥0.65%) are nausea, pruritus, constipation, headache, diarrhea, increased blood pressure, bleeding, hyperpigmentation, vein injury, taste alteration, burning/tingling sensation with injection, red sclera, allergic rhinitis, back pain, vomiting, and increased ALT. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, 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, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of FERABRIGHT was evaluated in three blinded read studies (Study 001, Study 002, and Study 003) in 225 patients with known or suspected neoplasms in the brain who received FERABRIGHT by intravenous infusion for MRI. In Study 001, 153 patients weighing between 45 kg and 140 kg received a FERABRIGHT median dose of 506 mg [see Clinical Studies ( 14 )]. …
Source: FDA drug label, Azurity Pharmaceuticals, Inc., effective October 14, 2025 (SPL set ac666008-a14f-43b4-9d06-ec70f45a4234), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,902 reports list ferumoxytol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 131 are coded as a death and 461 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, 13 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?
- Ferumoxytol: 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