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Ferrous Sulphate Uses, Dosage, Side Effects & Benefits | DrugsAtlas

Authoritative Clinical Reference

Therapeutic Class

Haematinic

Subclass

Oral Iron Supplement

Speciality

Haematology

Schedule (India)

Not scheduled (OTC — available without prescription)

Routes

Oral

Formulations

Form	Strengths Available (Elemental Iron)
Tablet (plain/film-coated)	60 mg, 100 mg elemental iron
Tablet (dried ferrous sulphate)	200 mg salt (~65 mg elemental iron)
Syrup	25 mg/5 mL, 30 mg/5 mL elemental iron
Drops	15 mg/mL, 25 mg/mL elemental iron

Note: All doses in this monograph refer to elemental iron content. Ferrous sulphate heptahydrate 300 mg ≈ 60 mg elemental iron; dried ferrous sulphate 200 mg ≈ 65 mg elemental iron.

Adult indications\\

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Iron Deficiency Anaemia (IDA) — Adults

Parameter	Dosing
Starting dose	100 mg elemental iron/day in 2 divided doses
Titration	Increase to 200 mg/day if tolerated and inadequate response at 3 weeks
Usual maintenance dose	100 mg/day (after Hb correction, continued for 3–6 months to replenish stores)
Maximum dose	200 mg elemental iron/day in divided doses

Clinical Notes:

Administer on empty stomach (1 hour before or 2 hours after meals) for optimal absorption
May take with food if GI intolerance occurs (reduces absorption by ~40%)
Continue therapy for 3–6 months after Hb normalisation to restore ferritin

2. Antenatal Iron Prophylaxis (National Health Mission Protocol)

Parameter	Dosing
Starting dose	60 mg elemental iron + 0.5 mg folic acid once daily
Titration	Not applicable
Usual maintenance dose	60 mg elemental iron/day
Maximum dose	100 mg elemental iron/day (if documented deficiency)
Duration	From second trimester until 3 months postpartum

Clinical Notes:

Standard component of ANC under NHM/ICDS programmes
Weekly iron-folic acid (WIFS) supplementation for non-pregnant adolescent girls: 100 mg elemental iron + 0.5 mg folic acid once weekly

3. Postpartum Anaemia

Parameter	Dosing
Starting dose	100 mg elemental iron twice daily
Titration	Not applicable
Usual maintenance dose	100–200 mg elemental iron/day
Maximum dose	200 mg elemental iron/day
Duration	3–6 months or until ferritin normalises

4. Iron Deficiency Anaemia in Inflammatory Bowel Disease (Mild, Oral-tolerant)

Parameter	Dosing
Starting dose	60 mg elemental iron once daily
Titration	Increase to 100 mg/day if tolerated
Usual maintenance dose	60–100 mg/day
Maximum dose	100 mg/day (higher doses may exacerbate GI symptoms)

Clinical Notes:

Prefer IV iron if oral not tolerated or in active disease flare
Monitor for worsening of GI symptoms

Secondary Indications — Adults Only (Off-label)

Indication	Dose	Duration	Supervision	Evidence
Anaemia secondary to menorrhagia	100–200 mg elemental iron/day	Tailored to blood loss; often long-term	Gynaecology input	Indian gynaecological practice; addresses ferritin depletion in heavy menstrual bleeding
Restless leg syndrome (with documented iron deficiency)	60–100 mg elemental iron/day	Until ferritin >50–75 µg/L	Specialist only; OFF-LABEL	International RCTs supportive; not standard in Indian guidelines

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Iron Deficiency Anaemia — Treatment

Age Group	Starting Dose	Titration	Usual Maintenance	Maximum Dose
2–6 months	2 mg/kg/day once daily	Not applicable	2–3 mg/kg/day	3 mg/kg/day
6 months – 2 years	3 mg/kg/day in 1–2 divided doses	May increase to 6 mg/kg/day if severe	3–6 mg/kg/day	6 mg/kg/day
2–5 years	3 mg/kg/day once or twice daily	Not applicable	3–6 mg/kg/day	6 mg/kg/day (max 60 mg/day)
5–12 years	3 mg/kg/day in 1–2 divided doses	Not applicable	3 mg/kg/day	120 mg/day
>12 years	Adult dosing	As per adult	As per adult	200 mg/day

Duration: Minimum 3 months or until ferritin normalises

Clinical Notes:

Use drops or syrup for infants and young children
Administer between meals; may give with small meals if intolerance occurs
Bitter taste may affect compliance — mixing with juice may help

Iron Prophylaxis — As per IAP/ICMR

Age Group	Dose	Duration
6–12 months	2 mg/kg/day elemental iron	Daily for high-risk; weekly for routine
1–5 years	2 mg/kg/day (max 30 mg/day)	As per nutritional status
5–10 years	30–45 mg/day	Weekly supplementation under WIFS

Secondary Indications — Paediatric Doses (Off-label)

Indication	Dose	Age	Supervision	Evidence
Prevention in preterm/LBW infants	2–3 mg/kg/day elemental iron	Start at 2–4 weeks of age	Specialist only; OFF-LABEL	IAP and WHO recommendations supportive

Safety Monitoring — Paediatrics

Confirm iron deficiency before initiating treatment (avoid empirical iron in non-IDA anaemias)
Monitor Hb response at 4 weeks
Risk of accidental overdose — counsel caregivers on safe storage
Iron drops may stain teeth — administer with dropper at back of mouth; rinse after

⚠️ CLEAR STATEMENT: Not recommended in infants <2 months except under specialist supervision in confirmed iron deficiency or high-risk preterm infants.

Renal Adjustments

No dose adjustment required for oral ferrous sulphate.

Additional Notes:

Oral iron is not nephrotoxic
GI tolerance may limit compliance in CKD patients
IV iron preferred in CKD stages 3b–5 and dialysis patients for better efficacy and compliance
Oral iron may interfere with phosphate binder efficacy if taken together

Hepatic adjustment

Contraindications

Known hypersensitivity to ferrous salts or any excipient
Haemochromatosis (primary or secondary)
Haemosiderosis
Non-iron-deficiency anaemias where iron is not indicated (e.g., thalassaemia major, sideroblastic anaemia)
Patients receiving regular blood transfusions with adequate iron stores
Active peptic ulcer disease with bleeding
Concurrent parenteral iron therapy

Cautions

History of peptic ulcer disease or gastritis (increased GI irritation risk)
Inflammatory bowel disease — may exacerbate disease activity
Elderly patients with constipation risk
Conditions with potential for iron overload (repeated transfusions, myelodysplasia)
Concurrent high-dose Vitamin C supplementation — may enhance absorption but increase GI effects
Strictures or diverticula of the GI tract (risk of retention)
Chronic kidney disease — assess need for IV iron if oral poorly tolerated

Pregnancy

Aspect	Details
Overall safety	Safe; recommended as standard component of antenatal care in India
Risk category	Not assigned; extensive safety data supports routine use
First trimester	May defer non-urgent supplementation to second trimester to reduce nausea
Second/Third trimester	Routine supplementation recommended per NHM guidelines
Preferred alternatives	None — ferrous sulphate is first-line; ferrous fumarate or ferrous gluconate if intolerant
Monitoring	Hb at booking, 28 weeks, 36 weeks; serum ferritin if available; assess GI tolerance

Lactation

Aspect	Details
Compatibility	Fully compatible with breastfeeding
Levels in breast milk	Very low; iron in breast milk is tightly regulated and not affected by maternal supplementation
Preferred alternatives	Not applicable — ferrous sulphate is first-line
Infant monitoring	Generally not required; observe for minor GI changes if concerned

Elderly

Aspect	Recommendation
Starting dose	60–100 mg elemental iron once daily
Titration	Increase gradually based on tolerance; avoid high doses
Maximum dose	100–150 mg/day usually sufficient
Special risks	Constipation (common and troublesome), pill-induced gastritis, oesophageal irritation if swallowed improperly
Additional considerations	Assess for underlying cause of IDA (GI malignancy, occult blood loss); IV iron may be preferred if oral not tolerated

Major drug interactions

Tetracyclines (doxycycline, tetracycline)	Reduced absorption of both iron and tetracycline	Chelation in GI tract	Avoid concurrent use; separate by ≥3 hours
Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin)	Reduced quinolone absorption (40–50%)	Chelation	Avoid concurrent use; separate by ≥2 hours (quinolone first)
Levothyroxine	Reduced thyroxine absorption	Chelation	Separate doses by ≥4 hours; monitor TSH
Dimercaprol	Formation of toxic iron-dimercaprol complex	Direct chemical interaction	CONTRAINDICATED
Methyldopa	Reduced methyldopa efficacy	Iron binding	Separate by ≥2 hours
Levodopa/Carbidopa	Reduced levodopa absorption	Chelation	Separate by ≥2 hours
Bisphosphonates (alendronate)	Reduced bisphosphonate absorption	Chelation	Separate by ≥2 hours
Mycophenolate	Reduced mycophenolate absorption	Chelation	Separate by ≥4 hours

Moderate drug interactions

Interacting Drug	Effect	Management
Antacids (aluminium/magnesium hydroxide)	Reduced iron absorption	Separate by ≥2 hours
Calcium supplements	Reduced iron absorption	Separate by ≥2 hours; take iron between meals
Proton pump inhibitors (omeprazole, pantoprazole)	Reduced iron absorption due to decreased gastric acid	Monitor Hb response; consider higher doses or IV iron if inadequate
H2 blockers (ranitidine, famotidine)	Reduced iron absorption	Same as PPIs
Zinc supplements	Competitive absorption	Separate by ≥2 hours
Vitamin C (ascorbic acid)	Enhanced iron absorption	May co-administer to improve efficacy; monitor for increased GI effects
Cholestyramine	Reduced iron absorption	Separate by ≥4 hours
Penicillamine	Reduced penicillamine absorption	Separate by ≥2 hours

Common Adverse effects

Nausea (5–20%)
Epigastric discomfort, abdominal pain
Constipation (very common in elderly)
Diarrhoea (less common)
Black/dark stools (harmless; may mask melena)
Metallic taste
Teeth staining (with liquid preparations)
Anorexia

Serious Adverse effects

Adverse Effect	Clinical Notes
Acute iron poisoning (accidental overdose)	Life-threatening, especially in children; presents with vomiting, diarrhoea, haematemesis, shock — requires immediate hospitalisation and deferoxamine
Pill-induced oesophagitis/ulceration	Occurs with improper swallowing; counsel to take with adequate water in upright position
Severe GI haemorrhage	Rare; in setting of pre-existing ulcer disease
Iron overload (with prolonged unnecessary use)	Monitor ferritin; discontinue when stores replete

Monitoring requirements

Phase	Parameters
Baseline	Hb, MCV, MCH, serum ferritin, transferrin saturation (if available); peripheral smear
After 2–3 weeks	Hb (expect rise of 1–2 g/dL); reticulocyte count (peaks at 7–10 days)
After 2–3 months	Hb (should normalise); repeat ferritin to assess store repletion
Long-term (if continued >3 months)	Ferritin every 3 months to avoid overload; investigate if inadequate response (occult blood loss, malabsorption, non-compliance)

Brands in India

Brand Name	Manufacturer	Formulation	Notes
Fefol	GSK	Capsule	FDC with folic acid
Orofer	Emcure	Drops, Syrup, Tablet	Plain and FDC variants
Livogen	Merck	Capsule	FDC with folic acid
Autrin	Sarabhai	Capsule	FDC with folic acid, B12, zinc
Dexorange	Franco-Indian	Syrup	FDC with B12, folic acid
Fersolate	Various	Tablet	Plain ferrous sulphate
Hemfer	Alkem	Drops, Syrup	Paediatric formulations
Tonoferon	East India	Drops, Syrup	Paediatric use

Note: Multiple FDCs available with folic acid, Vitamin B12, Vitamin C, and zinc — always verify elemental iron content per unit when prescribing.

Price range (INR)

Formulation	Price Range	Notes
Tablet (60 mg elemental iron)	₹0.50–₹2.00 per tablet	NLEM listed; price controlled
Tablet (100 mg elemental iron)	₹1.00–₹3.00 per tablet
Syrup (100 mL)	₹25–₹90 per bottle	Brand-dependent
Drops (15 mL)	₹25–₹60 per bottle	Paediatric formulation
FDC with folic acid	₹1.00–₹4.00 per tablet/capsule	Common ANC formulation

Government Supply: Available free under NHM/ANC programmes and Jan Aushadhi stores at subsidised rates.

Clinical pearls

Dose by elemental iron, not salt weight: Ferrous sulphate 300 mg = 60 mg elemental iron; ferrous fumarate 200 mg = 66 mg elemental iron — prescriptions must specify elemental iron content.
GI side effects are dose-limiting: Consider alternate-day dosing (same total weekly dose) if daily dosing not tolerated — evidence suggests comparable efficacy with improved adherence.
Citrus enhances absorption: Taking iron with Vitamin C (orange juice, amla) improves absorption; avoid tea, coffee, milk within 2 hours of dosing.
Black stools are expected: Counsel patients proactively — prevents unnecessary alarm and investigation; however, if stools are tarry/melenic in consistency, evaluate for GI bleed.
Confirm deficiency before treating: Avoid empirical long-term iron in non-IDA anaemias (thalassaemia trait, anaemia of chronic disease) — risk of iron overload.
Inadequate response warrants investigation: If Hb does not rise by 1 g/dL at 3–4 weeks despite compliance, investigate for ongoing blood loss, malabsorption, or incorrect diagnosis.

Version

RxIndia v1.0 — 09 May 2025

Reference

- CDSCO approved product information
- Indian Pharmacopoeia 2022
- National List of Essential Medicines (NLEM) 2022
- API Textbook of Medicine (11th Edition)
- ICMR Guidelines on Haematinics Use (2016)
- National Health Mission — Anaemia Mukt Bharat Programme Guidelines
- IAP Guidelines for Iron Supplementation in Paediatrics
- AIIMS Drug Formulary
- WHO Guideline: Daily Iron Supplementation (supportive)

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This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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