What over-the-counter (OTC) iron supplements are recommended for children with iron deficiency?

Over-the-Counter Iron Supplements for Children

Recommended Formulation and Dosing

Ferrous sulfate drops at 3 mg/kg per day of elemental iron, administered between meals, is the standard first-line over-the-counter iron supplement for children with iron deficiency anemia. 1, 2

Specific Product Information

• Each ferrous sulfate tablet contains 324 mg of ferrous sulfate, equivalent to 65 mg of elemental iron 3
• For young children, liquid ferrous sulfate drops are preferred over tablets for ease of administration and accurate dosing 1, 4
• The dose should be calculated based on elemental iron content, not the total ferrous sulfate weight 2

Administration Guidelines

• Administer iron between meals (not with meals) to maximize absorption, as food significantly decreases iron bioavailability 4
• Include vitamin C-rich foods or juice with iron supplementation to enhance absorption 1
• Continue treatment for 2-3 months after hemoglobin normalization to replenish iron stores 5, 2

Age-Specific Dosing

Infants and Toddlers (Standard Risk)

• 3 mg/kg per day of elemental iron for children aged 9 months to 5 years with presumptive iron deficiency anemia 1, 2

High-Risk Infants (Preterm/Low Birthweight)

• 2-4 mg/kg per day of iron drops starting at 1 month of age and continuing until 12 months 2

Breastfed Infants

• 1 mg/kg per day of iron drops by 6 months of age if supplementary foods provide insufficient iron 2

School-Age Children

• One 60-mg iron tablet daily for children aged 5-12 years with confirmed iron deficiency anemia 1

Treatment Monitoring and Confirmation

• Recheck hemoglobin or hematocrit after 4 weeks of treatment 1, 2
• An increase in hemoglobin ≥1 g/dL or hematocrit ≥3% confirms the diagnosis of iron deficiency anemia 1, 2, 4
• If confirmed, continue iron treatment for 2 additional months, then recheck hemoglobin 1
• Reassess hemoglobin approximately 6 months after successful treatment completion 1

Superiority of Ferrous Sulfate Over Alternative Formulations

While other iron formulations exist over-the-counter, ferrous sulfate demonstrates superior efficacy compared to alternatives:

• Ferrous sulfate resulted in a 1.0 g/dL greater increase in hemoglobin compared to iron polysaccharide complex at 12 weeks 6
• Complete resolution of iron deficiency anemia occurred in 29% with ferrous sulfate versus only 6% with iron polysaccharide complex 6
• Ferrous sulfate increased serum ferritin by 10.2 ng/mL more than iron polysaccharide complex 6
• Ferrous sulfate showed better clinical response and fewer adverse effects than iron polymaltose complex 7

Common Side Effects and Management

• Mild gastrointestinal symptoms (nausea, vomiting, diarrhea) are common but should not necessarily prompt discontinuation 4
• Contrary to older assumptions, ferrous sulfate may actually cause less diarrhea than some alternative formulations like iron polysaccharide complex (35% vs 58%) 6
• Drug-related adverse events are rare, occurring in approximately 5% of patients 8

When to Pursue Further Evaluation

If anemia does not respond after 4 weeks despite compliance and absence of acute illness, further laboratory evaluation is required 1, 4:

• Measure mean corpuscular volume (MCV), red cell distribution width (RDW), and serum ferritin 1
• Serum ferritin ≤15 μg/L confirms iron deficiency 1
• Serum ferritin >15 μg/L suggests iron deficiency is not the cause of anemia 1

Critical Safety Considerations

• Do not exceed recommended doses to avoid systemic iron toxicity with hepatocellular damage, which has been reported at 16 mg/kg 5, 4
• Monitor for iron overload in patients requiring repeated or prolonged courses 5, 2
• Provide concurrent dietary counseling to address underlying inadequate iron intake 1, 2, 4