Drug reference

Ferrous Sulfate

Oral iron salt (haematinic) · Antianemic; Micronutrient Supplement

Also known as Ferrous Sulphate, Iron(II) Sulfate, Iron Sulfate, FESOL

START

200 mg ferrous sulfate (≈65 mg elemental) once daily

TYPICAL MAX

~180–200 mg elemental iron/day

STOP IF

Iron overload, intolerable GI effects, or no response (reassess)

WATCH

Hb/ferritin response; keep away from children (overdose)

CDSCO approvedOTC (Over The Counter) for standard doses; Schedule H for certain higher strength or parenteral preparations in India, but generally considered OTC for common oral forms. For common oral formulations, it is widely available without prescription in India. Therefore, predominantly OTC for typical use but can be Schedule H for specific forms or higher strengths requiring prescription, as per Indian drug regulations. For the purpose of a general entry, 'OTC' is appropriate for its common availability and use in India for iron deficiency. However, some specific high-dose preparations or injectable forms could fall under Schedule H/H1, necessitating a prescription. Considering the prompt for Indian context, 'OTC, with some higher strength or parenteral forms potentially Schedule H' is most accurate. But for brevity and common understanding: 'OTC'. Let's stick to OTC for the main molecule as it's typically available over-the-counter for routine iron deficiency. Schedule H would be for specific, controlled preparations which are less common for basic ferrous sulfate. A standard drug reference often leans towards the most common regulatory status. So, 'OTC' is probably the best fit.ATC B03AA07

Dose laddermg/d

Renal dose adjustmenteGFR mL/min/1.73m²

KDIGO 2024 + manufacturer label

Pharmacokineticsplasma · t hours

ONSET: 3d · reticulocytosis
PEAK: 8w · Hb ~8 wk
t½: 36s · physiologic
DURATION: 1d · daily dosing

EXCRETION

No active excretion; losses via shed cells

route + CYP

INTERACTIONS

—

none in our sources

PREGNANCY

Safe and recommended where indicated in pregnancy.

FDA category + note

Available in India

1 branded formulation. Look up specific brands in the Drugs workspace.

Mechanism

Provides ferrous iron (Fe2+) for absorption in the duodenum, replenishing iron stores for haemoglobin and myoglobin synthesis in iron-deficiency states.

Indications

Iron-deficiency anaemia (treatment)Prevention of iron deficiency (pregnancy, increased demand)

Dosing

Adult: Treatment: ferrous sulfate 200 mg (≈65 mg elemental) 1–3 times daily (alternate-day dosing improves absorption). Prophylaxis: 200 mg once daily.
Pediatric: 3–6 mg/kg/day elemental iron in 1–3 divided doses.
Renal adjustment: No adjustment for oral iron (consider IV iron in CKD/ESRD).
Hepatic adjustment: No specific adjustment.
Geriatric: Once-daily/alternate-day often better tolerated.
Max dose: ~180–200 mg elemental iron/day (treatment)

Pharmacokinetics

Onset

Reticulocytosis ~3–10 days; Hb rises over weeks

Peak effect

Hb normalises in ~6–8 weeks; replete stores 3 months

Duration

Dosing-dependent

Half-life

Not applicable (physiologic iron handling)

Bioavailability

~10–20% (higher when iron-deficient; food reduces)

Protein binding

Transported on transferrin

Metabolism

Not metabolised (incorporated into haem)

Excretion

No active excretion; losses via shed cells/blood

Contraindications

Haemochromatosis / iron-overload states
Haemolytic anaemia (without iron deficiency)
Repeated blood transfusions
Hypersensitivity

Side effects

Common

ConstipationNausea/epigastric discomfortBlack stoolsDiarrhoeaMetallic taste

Serious

Acute iron overdose (esp. children — potentially fatal)
GI mucosal ulceration (modified-release lodgement)
Iron overload (chronic excess)

Pregnancy & lactation

Pregnancy

Safe and recommended where indicated in pregnancy.

Lactation

Compatible with breastfeeding.

Drug interactions

Ciprofloxacin

Moderate

Textbook-cited

Therapeutic failure of the antibiotic.