Applies to carbonyl iron: oral tablet chewable. Other dosage forms:
- oral suspension
Warning
- Accidental overdose of drugs that have iron in them is a leading cause of deadly poisoning in children younger than 6 years of age. Keep away from children. If this drug is taken by accident, call a doctor or poison control center right away.
Serious side effects of Carbonyl iron
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Black, tarry, or bloody stools.
- Fever.
- Very upset stomach or throwing up.
- Very bad belly pain.
- Throwing up blood or throw up that looks like coffee grounds.
Other side effects of Carbonyl iron
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Upset stomach or throwing up.
- Not hungry.
- Constipation.
- Change in color of stool to green.
- Diarrhea.
- Belly pain.
- Stomach cramps.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to carbonyl iron: oral suspension, oral tablet, oral tablet chewable.
Gastrointestinal
Gastrointestinal side effects have been reported the most frequently. They have included diarrhea (45%) vs. placebo (3%), cramping (38%) vs. placebo (0%), nausea (30%) vs. placebo (8%), constipation (25%) vs. placebo (14%), heartburn (17%) vs. placebo (6%), and epigastric discomfort (16%) vs. placebo (11%).[Ref]
Constipation may be relieved by administering docusate sodium 100 mg to 200 mg per day in addition to increasing the intake of oral fluids, such as water.[Ref]
Other
Iron overload (i.e., hemosiderosis) has been reported in patients genetically predisposed, or have underlying disorders, that augment the absorption of iron. It has also occurred following administration of excessive parenteral iron therapy, combination of oral and parenteral iron, or in patients with hemoglobinopathies that were erroneously diagnosed as iron deficiency anemia. Hemosiderosis is treated with repeated phlebotomy or long-term administration of deferoxamine. The liver is particularly susceptible to toxicity in iron-overload states.
Stained teeth have been reported primarily following ingestion of iron liquid preparations. Liquid dosage forms should be diluted in juice or water and sipped through a straw to aid in prevention of staining.[Ref]
Other side effects have included iron overload (hemosiderosis) and stained teeth. Secondary hemochromatosis due to prolonged iron ingestion has been reported rarely. An unpleasant taste following carbonyl iron ingestion has been reported in 40% to 70% of patients.[Ref]
Nervous system
Nervous system side effects have included headache (29%) vs. placebo (25%), and weakness (11%) vs placebo (9%).[Ref]
