Ferrous Sulfate: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: May 15, 2026🚩 Report this page

Ferrous Sulfate

Iron Bivalent, Oral Preparations

Sold as Ferrum Quartz

GB MHRAUS FDA

Drug class: Iron Bivalent, Oral Preparations
Availability: Over-the-counter
Routes: Oral
Markets covered: 2
Products on record: 5
FDA reports (12 mo): 3,312

Overview

Ferrous Sulfate is an active pharmaceutical ingredient in the Iron Bivalent, Oral Preparations group (B03AA). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	4	May 15, 2026
US United States	FDA	1	August 1, 2025

GBUnited Kingdom· MHRA

4 products

Uses

GBOfficial regulatory label· revised April 22, 2025[1]

Iron-deficiency anaemia.

How to take

GBOfficial regulatory label· revised April 22, 2025

USUnited States· FDA

1 product

Uses

USOfficial regulatory label· revised August 1, 2025[2]

Directions:
FOR ORAL USE ONLY.

How to take

USOfficial regulatory label

Sources & citations

[1]MHRA (UK) · PL317500113 · revised April 22, 2025
[2]FDA DailyMed · 052f687f-2263-94… · revised August 1, 2025 [PDF]
[3]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised April 22, 2025[1]

Immune system disorders:
Allergic reactions have been reported Gastro-intestinal disorders: abdominal pain, nausea and vomiting (these are usually dose related), constipation, diarrhoea and dark stools. Contact irritation can occur with ferrous sulphate tablets resulting in erosion or ulceration, particularly if they become lodged in the upper gastrointestinal tract.
Gastro-intestinal, including discomfort and anorexia.
Post-marketing:
The following ADR has been reported during post-marketing surveillance. The frequency of this reaction is considered not known (cannot be estimated from the available data). Gastro-intestinal disorders: mouth ulceration* *in the context of incorrect administration, when the tablets are chewed, sucked or kept in mouth.
4), in case of false route. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised April 22, 2025[1]

Some post-gastrectomy patients show poor absorption of iron. Caution is advised when prescribing iron preparations to individuals with history of peptic ulcer, and inflammatory bowel disease, including regional enteritis and ulcerative colitis.
Care should be taken in patients with intestinal strictures or diverticulae. Duration of treatment should generally not exceed 3 months after correction of anaemia. Dental caries is a definite risk following long-term treatment with this product.
Due to the risk of mouth ulcerations and tooth discolouration, tablets should not be sucked, chewed or kept in the mouth, but swallowed whole with water. Patients suffering from iron overload are particularly susceptible to infection.
Treatment of iron overload should be with caution. Co-existing deficiency of vitamin B12 or folic acid should be ruled out since combined deficiency produces microcytic blood film. Aspiration of iron sulfate tablets can cause necrosis of the bronchial mucosa which may result in coughing, haemoptysis, bronchostenosis and/or pulmonary infection (even if aspiration happened days to months before these symptoms occurred).
Elderly patients and patients who have difficulties swallowing should only be treated with iron sulfate tablets after a careful evaluation of the individual patient’s risk of aspiration. Alternative formulations should be considered.
Patients should seek medical attention in case of suspected aspiration.
The label will state: “Important warning:
Contains Iron. Keep out of the sight and reach of children, as overdose may be fatal”. This will appear on the front of the pack within a rectangle in which there is no other information.

This is not medical advice. Consult a qualified healthcare professional.

Overview

Regulatory status by market

GBUnited Kingdom· MHRA

USUnited States· FDA

Drugs in the same class

Sources & citations