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All research profiles

Mineral / hematologic

Iron

Prepared by the ezGLP team. Sources last checked . Profile reviewed .

Also known as Ferrous sulfate, Ferrous gluconate, Ferrous fumarate

Routes represented in the knowledgebase: Oral.

Educational overview

Confirm deficiency and formulation. Oral overdose can be fatal in children, while IV products carry hypersensitivity and hypotension risks.

Iron is an essential mineral and the functional core of haemoglobin, myoglobin, and many enzymes involved in oxygen transport, energy production, and DNA synthesis. Dietary iron is absorbed in the duodenum under the control of the hormone hepcidin, and there is no physiological route for excreting excess, so the body regulates iron by limiting uptake. Iron deficiency is the most common nutritional deficiency worldwide and the leading cause of anaemia. Oral supplements contain ferrous salts (sulfate, gluconate, fumarate), polysaccharide-iron complexes, or heme iron, which differ in elemental iron content and gastrointestinal tolerability. Intravenous iron products such as iron dextran, iron sucrose, ferric carboxymaltose, ferumoxytol, and ferric derisomaltose are prescription drugs for deficiency that oral iron cannot correct.

The evidence base is large and mature. Randomized trials establish that oral iron corrects iron-deficiency anaemia, and absorption studies show that hepcidin rises after each dose, which is why less frequent schedules absorb comparably with fewer side effects. Intravenous iron trials show faster repletion in chronic kidney disease, heart failure, inflammatory bowel disease, and pregnancy, and the agents differ in their rates of hypersensitivity reactions. Toxicity is equally well documented: acute overdose causes corrosive gut injury, shock, and liver failure, and accidental ingestion of iron supplements was a leading cause of fatal poisoning in young children in the United States in the 1980s and 1990s, which prompted the mandatory warning label. Hereditary haemochromatosis makes ordinary supplement amounts harmful over years.

In the United States, oral iron is a dietary supplement, but FDA requires solid iron-containing supplements to carry a warning that accidental overdose is a leading cause of fatal poisoning in children under six. Intravenous iron products are FDA-approved prescription drugs: iron dextran (INFeD) carries a boxed warning for anaphylactic-type reactions, including fatalities, and its label calls for a test dose and resuscitation facilities, while the newer agents carry serious hypersensitivity warnings of their own. Intramuscular iron is now rarely used. No compounded injectable iron has approved status, and injectable iron sold outside pharmacy channels is unapproved. Other jurisdictions treat oral iron as a food supplement or pharmacy medicine and every intravenous iron product as a prescription-only medicine given under observation.

Oral iron is stable at room temperature in a closed container and, because of the paediatric poisoning history, is sold in child-resistant packaging. Intravenous products are stored per label and administered in clinical settings with observation for reactions. For a record, the salt and its elemental iron figure are the important numbers, since ferrous sulfate, gluconate, and fumarate tablets of similar weight contain very different amounts of iron. Timing relative to levothyroxine, quinolone and tetracycline antibiotics, calcium, and zinc is relevant because iron reduces their absorption or they reduce its, and dark stools and constipation are expected effects worth logging rather than alarming signs. Ferritin and transferrin saturation dated against the dose log show whether repletion is progressing.

Category
Mineral / hematologic
Routes represented
Oral
Storage context
Follow the product label; store in the original container away from excess heat and moisture.
Authoritative overview

Published literature

No verified PubMed or DOI link is available for this entry.

Safety evidence

Common or reported: constipation, nausea, abdominal pain, vomiting, diarrhea.

Serious or important: intestinal injury, shock, organ failure, and death in overdose, especially in children.

Safety evidence source

Interaction evidence

These are general, pairwise evidence notes. Green identifies the potential-synergy category, while Lv3/Lv2/Lv1 communicates evidence strength; it does not guarantee benefit or cancel a safety warning.

With levothyroxine

Safety flag

Oral iron reduces levothyroxine absorption and can reduce treatment effectiveness.

Interaction evidence source

With Ascorbic acid

Complementary evidenceLv3

Vitamin C can increase the absorption and bioavailability of nonheme iron.

Interaction evidence source

Common questions

Is there an FDA-approved iron injection, and what are its warnings?

Yes, several. Iron dextran (INFeD), iron sucrose, ferric carboxymaltose, ferumoxytol, and ferric derisomaltose are FDA-approved intravenous prescription products for iron deficiency when oral iron is ineffective or cannot be used. The iron dextran label carries a boxed warning that anaphylactic-type reactions, including deaths, have occurred, that a test dose precedes the first therapeutic dose, and that resuscitation equipment must be available. Other agents carry hypersensitivity warnings.

Why do iron supplements carry a child poisoning warning?

Because accidental ingestion of iron tablets killed dozens of young children in the United States between the early 1980s and 2000, at one point accounting for around a third of paediatric poisoning deaths. FDA responded with a mandatory label statement that accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six, and manufacturers adopted child-resistant packaging and film coatings. Deaths fell sharply afterwards.

What is the difference between ferrous sulfate, gluconate, and fumarate?

They are different salts of the same ferrous iron and differ mainly in how much elemental iron each milligram of tablet contains: fumarate is the most concentrated, sulfate intermediate, and gluconate the least. Absorption per milligram of elemental iron is similar, so the elemental figure on the label is the comparable number. Tolerability differences between salts are modest and relate largely to the amount of iron delivered.

Does iron interact with levothyroxine or antibiotics?

Yes. Oral iron binds levothyroxine in the gut and reduces its absorption, which can raise TSH in people on thyroid replacement, and it chelates quinolone and tetracycline antibiotics so that both drugs are absorbed less. Iron also competes with zinc and calcium for absorption. The NIH fact sheet lists these interactions, and separating administration times is the usual approach discussed with prescribers.

Further reading

Summarised from published literature for reference only, with citations to the source. Evidence is graded as reported and is not a recommendation to combine, dose, or use any compound.

For personal tracking and education only. Not medical advice, diagnosis, or treatment, and not a medical device. Peptides may be prescription-only or unapproved where you live. Consult a licensed healthcare professional.