Ferrous sulfate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Adeel Jamil, M.D. [2]
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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Overview
Ferrous sulfate is a essential minerals that is FDA approved for the treatment of iron deficiency and iron deficiency anemia. Common adverse reactions include constipation, darkened colored stools, diarrhea, nausea and stomach upset..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Iron Supplement Therapy
- Ferrous Sulphate is an iron supplement for iron deficiency and iron deficiency anemia when the need for such therapy has been determined by a physician.
Dosing Information
- Adults and children 12 years and over : take 1 tablet daily or as directed by a doctor
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ferrous sulfate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ferrous sulfate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
- Children under 12 years : consult a physician.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ferrous sulfate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ferrous sulfate in pediatric patients.
Contraindications
There is limited information regarding Contraindications of Ferrous sulfate in pediatric patients.
Warnings
- Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a physician. Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within tow hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing products may occasionally cause constipation or diarrhea.
- If are pregnant or nursing a baby, seek the advise of a health professional before using this products.
- Warning: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Ferrous sulfate in the drug label.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Ferrous sulfate in the drug label.
Drug Interactions
There is limited information regarding Drug Interactions of Ferrous sulfate in the drug label.
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ferrous sulfate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ferrous sulfate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Ferrous sulfate with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Ferrous sulfate with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Ferrous sulfate with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Ferrous sulfate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ferrous sulfate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ferrous sulfate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ferrous sulfate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ferrous sulfate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ferrous sulfate in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Ferrous sulfate in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Ferrous sulfate in the drug label.
Overdosage
There is limited information regarding Chronic Overdose of Ferrous sulfate in the drug label.
Pharmacology
There is limited information regarding Ferrous sulfate Pharmacology in the drug label.
Mechanism of Action
Structure
There is limited information regarding Ferrous sulfate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Ferrous sulfate in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Ferrous sulfate in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Ferrous sulfate in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Ferrous sulfate in the drug label.
How Supplied
Storage
- Store at room temperature
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Ferrous sulfate in the drug label.
Precautions with Alcohol
- Alcohol-Ferrous sulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- Feosol®
Look-Alike Drug Names
There is limited information regarding Ferrous sulfate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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