FE-40 Side Effects
Generic Name: ferrous gluconate
Note: This page contains information about the side effects of ferrous gluconate. Some of the dosage forms included on this document may not apply to the brand name FE-40.
For the Consumer
Applies to ferrous gluconate: capsules, tablets
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking ferrous gluconate (the active ingredient contained in FE-40)
Constipation; darkened or green stools; diarrhea; loss of appetite; nausea; stomach cramps, pain, or upset; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stool; fever; severe or persistent nausea, stomach pain, or vomiting; vomit that looks like blood or coffee grounds.
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 (the active ingredient contained in FE-40)
Oral preparations may rarely cause Hemoccult-positive stools, patients with positive tests generally require further work-up.[Ref]
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.[Ref]
Stained teeth have primarily occurred following ingestion of ferrous gluconate (the active ingredient contained in FE-40) 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.[Ref]
Other side effects have included stained teeth and iron overload (hemosiderosis). Secondary hemochromatosis due to prolonged iron ingestion has been reported rarely.[Ref]
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.[Ref]
Immunologic side effects have rarely included gastroenteritis associated with Yersinia enterocolitica and Listeria monocytogenes in patients with iron overload status receiving treatment with deferoxamine.[Ref]
Local side effects have included gangrene.[Ref]
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.[Ref]
1. Hutchins L, Lipschitz D "Iron and folate metabolism in renal failure." Semin Nephrol 5 (1985): 142-6
2. Laine LA, Bentley E, Chandrasoma P "Effect of oral iron therapy on the upper gastrointestinal tract. A prospective evaluation." Dig Dis Sci 33 (1988): 172-7
3. Brock C, Curry H, Hanna C, Knipfer M, Taylor L "Adverse effects of iron supplementation: a comparative trial of a wax- matrix iron preparation and conventional ferrous sulfate tablets." Clin Ther 7 (1985): 568-73
4. M'Seffar A, Fornasier VL, Fox IH "Arthropathy as the major clinical indicator of occult iron storage disease." JAMA 238 (1977): 1825-8
5. Bacon BR "Causes of iron overload." N Engl J Med 326 (1992): 126-7
6. Falk RJ, Mattern WD, Lamanna RW, Gitelman HJ, Parker NC, Cross RE, Rastall JR "Iron removal during continuous ambulatory peritoneal dialysis using deferoxamine." Kidney Int 24 (1983): 110-2
7. Pollycove M "Iron overload syndromes." Clin Physiol Biochem 4 (1986): 61-77
8. Gordeuk VR, Bacon BR, Brittenham GM "Iron overload: causes and consequences." Annu Rev Nutr 7 (1987): 485-508
9. Mofenson HC, Caraccio TR, Sharieff N "Iron sepsis: Yersinia enterocolitica septicemia possibly caused by an overdose of iron." N Engl J Med 316 (1987): 1092-3
10. Boelaert JR, van Landuyt HW, Valcke YJ, Cantinieaux B, Lornoy WF, Vanherweghem JL, Moreillon P, Vandepitte JM "The role of iron overload in Yersinia enterocolitica and Yersinia pseudotuberculosis bacteremia in hemodialysis patients." J Infect Dis 156 (1987): 384-7
11. Abcarian PW, Demas BE "Systemic Yersinia enterocolitica infection associated with iron overload and deferoxamine therapy." AJR Am J Roentgenol 157 (1991): 773-5
12. Fakir M, Saison C, Wong T, Matta B, Hardin JM "Septicemia due to Yersinia enterocolitica in a hemodialyzed depleted patient receiving omeprazole and oral iron supplementation." Am J Kidney Dis 19 (1992): 282-4
13. Mazzoleni G, deSa D, Gately J, Riddell RH "Yersinia enterocolitica infection with ileal perforation associated with iron overload and deferoxamine therapy." Dig Dis Sci 36 (1991): 1154-60
14. Leighton PM, MacSween HM "Yersinia hepatic abscesses subsequent to long-term iron therapy." JAMA 257 (1987): 964-5
15. Mossey RT, Sondheimer J "Listeriosis in patients with long-term hemodialysis and transfusional iron overload." Am J Med 79 (1985): 397-400
16. Alaily AB "Gangrene of Meckel's diverticulum in pregnancy due to iron tablet." Br Med J 1 (1974): 103
17. Shaffer JL, Higham C, Turnberg LA "Hazards of slow-release preparations in patients with bowel strictures." Lancet 2 (1980): 487
Not all side effects for FE-40 may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
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