What the label lists and what reports show
Iron dextran side effects
Iron dextran's FDA label: “Most common adverse reactions are nausea, vomiting, chest pain, backache, hypersensitivity, dyspnea, hypotension, pruritus, flushing, dizziness.” FAERS holds 1,436 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 (256 reports).
- No generic listed
- Boxed warning
Check it at the source: the iron dextran FDA label on DailyMed (effective August 2, 2024, Allergan, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions are nausea, vomiting, chest pain, backache, hypersensitivity, dyspnea, hypotension, pruritus, flushing, dizziness.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Delayed Reactions [see Warnings and Precautions ( 5.2 )] Increased Risk of Toxicity in Patients with Underlying Conditions [see Warnings and Precautions ( 5.3 )] Iron Overload [see Warnings and Precautions ( 5.4 ) ] Fetal bradycardia [see Use in Specific Populations ( 8.1 )] The following adverse reactions associated with the use of INFeD were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea. General disorders and administration site conditions: chest pain, chest tightness, weakness, malaise, febrile episodes, chills, shivering, sterile abscess, atrophy/fibrosis (intramuscular injection site), brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites, swelling, inflammation. …
Source: FDA drug label, Allergan, Inc., effective August 2, 2024 (SPL set 94b01b1e-794b-4bea-8e24-2e54683fc023), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,436 reports list iron dextran among the medicines taken, each a report of something that happened, not proof the medicine caused it; 123 are coded as a death and 348 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, 12 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?
- Iron dextran: 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