Ferrous gluconate Side Effects
Some side effects of ferrous gluconate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to ferrous gluconate: oral capsule, oral liquid, oral tablet, oral tablet extended release
Get emergency medical help if you have any of these signs of an allergic reaction while taking ferrous gluconate: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor if you have serious side effects such as:
bright red blood in your stools; or
pain in your chest or throat when swallowing a ferrous gluconate tablet.
Less serious side effects of ferrous gluconate may include:
nausea, vomiting, heartburn;
stomach pain, upset stomach;
black or dark-colored stools or urine; or
temporary staining of the teeth.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
For Healthcare Professionals
Applies to ferrous gluconate: compounding powder, oral capsule, oral liquid, oral tablet, oral tablet extended release
Gastrointestinal side effects are generally dose-related and have included nausea, constipation, anorexia, heartburn, vomiting and diarrhea. In addition, stools may appear darker in color in patients taking ferrous gluconate.
Oral preparations may rarely cause Hemoccult-positive stools, patients with positive tests generally require further work-up.
The gluconate salt is generally less irritating to the gastrointestinal tract compared to the sulfate salt. Gastrointestinal side effects may be further minimized by initiating ferrous gluconate therapy at smaller doses and gradually titrating upwards until the desired dose is achieved.
Gastrointestinal discomfort may also be minimized by administering each dose with food. However, concurrent administration of ferrous gluconate with food may decrease the amount of iron absorbed.
The use of enteric-coated or delayed release iron preparations may reduce adverse effects because of the small amount of iron released and absorbed. Enteric-coated or delayed-release ferrous gluconate products are not recommended for use.
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.
Stained teeth have primarily occurred following ingestion of ferrous gluconate liquid preparation. Liquid dosage forms should be diluted in juice or water and sipped through a straw to aid in prevention of staining.
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.
Other side effects have included stained teeth and iron overload (hemosiderosis). Secondary hemochromatosis due to prolonged iron ingestion has been reported rarely.
It has been hypothesized that gastroenteritis is caused by bacteria that become virulent in the presence of iron overload resulting in a systemic infection. Treatment consists of discontinuing deferoxamine and initiating appropriate antimicrobial therapy.
Immunologic side effects have rarely included gastroenteritis associated with Yersinia enterocolitica and Listeria monocytogenes in patients with iron overload status receiving treatment with deferoxamine.
Local side effects have included gangrene.
Localized corrosion has been reported in a pregnant woman taking ferrous sulfate (tablet) that lodged in a Meckel's diverticulum.
There have also been reports of wax-matrix ferrous sulfate tablets (delayed-release) lodging in the bowels of patients with strictures.
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