Ferrous fumarate

Ferrous fumarate tablets can be used during pregnancy if clinically indicated.

No adverse effects of ferrous fumarate have been shown in breastfed infants of treated mothers. Ferrous fumarate tablets can be used during breast-feeding if clinically indicated.

Not relevant.

The following adverse reactions are classified by system organ class and ranked under heading of frequency using the following convention:

Not known: frequency cannot be estimated from the available data

Gastrointestinal disorders:

• Gastro-intestinal irritation and darkening of stools can occur with iron salts. Nausea and epigastric pain are dose-related but the relationship between dose and altered bowel habit (constipation or diarrhoea) is less clear. Oral iron, particularly modified-release preparations, can exacerbate diarrhoea in patients with inflammatory bowel disease; care is also needed in patients with intestinal strictures and diverticular disease.
• Iron preparations taken orally can be constipating, particularly in older patients and occasionally lead to faecal impaction.
• If side-effects occur, the dose may be reduced; alternatively, another iron salt may be used but an improvement in tolerance may simply be a result of a lower content of elemental iron.

Paediatric population

Iron preparations are a common cause of accidental overdose in children.