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Post marketing: The following adverse drug reactions have been reported during post-marketing surveillance. The frequency of these reactions is considered not known (cannot be estimated from the available data).
Ferrous sulfate: Immune system disorders: Allergic reaction from rash to anaphylaxis.
Gastrointestinal disorders: Injury to mouth and pharynx (throat), mouth ulceration (in cases of incorrect use, when tablets are chewed, suck or left in the mouth), esophageal ulcer (i.e ulcer on the tube that connects the mouth with the stomach), nausea, vomiting, abdominal pain or discomfort hematemesis, blackening of stools, diarrhea, constipation, ileus.
Elderly patients and patients with difficulty swallowing may also be at risk of ulceration of the throat, oesophagus (the tube that connects the mouth with the stomach) or bronchus (the major air passages of the lungs) if the tablet enters the airways.
The likelihood of gastric intolerance to iron in the controlled-release Gradumet vehicle is remote. If such should occur, the tablet may be taken after a meal.
Vitamin C (Ascorbic Acid): Ascorbic acid is usually well tolerated. However, large doses are reported to cause diarrhea and other gastrointestinal disturbances and are associated with the formation of renal calcium oxalate calculi.
Folic acid: Immune system disorders: Hypersensitization has been reported following both oral and parenteral administration of folic acid.
