Ferrous Sulphate Uses, Dosage, Side Effects & Benefits | DrugsAtlas
Authoritative Clinical Reference
Navigation
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)
⚖️
Clinical Responsibility
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.
Content Feedback
Is this information helpful?
Help us improve our clinical database for the medical community.