Ferrous sulfate represents the gold standard in oral iron supplementation, engineered to address iron deficiency anemia and support robust erythropoiesis. This monograph provides a comprehensive clinical overview of ferrous sulfate’s pharmacological profile, therapeutic applications, and essential safety information. It is formulated for high elemental iron bioavailability, ensuring efficient correction of hemoglobin and ferritin levels in deficient states. Healthcare professionals can rely on this agent for evidence-based management of iron-related hematological disorders.

Features

• Contains 325 mg ferrous sulfate, delivering 65 mg of elemental iron per tablet
• Formulated with a stabilizing agent to minimize oxidation and enhance shelf life
• Film-coated to reduce gastric irritation and improve patient compliance
• Manufactured under cGMP (current Good Manufacturing Practices) standards
• Includes a desiccant in packaging to maintain stability and potency

Benefits

• Rapidly increases serum iron levels to support hemoglobin synthesis
• Effectively restores iron stores, alleviating symptoms of fatigue and weakness
• Improves cognitive function and physical performance in iron-deficient individuals
• Supports oxygen transport and cellular metabolism
• Reduces risk of complications associated with prolonged iron deficiency anemia
• Promotes healthy red blood cell production and maturation

Common use

Ferrous sulfate is primarily indicated for the treatment of iron deficiency anemia, confirmed by laboratory findings of low hemoglobin, reduced mean corpuscular volume (MCV), low serum ferritin, and decreased transferrin saturation. It is commonly prescribed during pregnancy to meet increased iron demands, for patients with chronic blood loss (e.g., from gastrointestinal lesions or menorrhagia), in individuals with malabsorption syndromes, and for those with inadequate dietary iron intake. It may also be used prophylactically in high-risk populations.

Dosage and direction

The typical adult therapeutic dose is 325 mg (one tablet) orally two to three times daily, providing 130-195 mg of elemental iron per day. For prophylaxis, 325 mg once daily is generally sufficient. Administer on an empty stomach, at least 1 hour before or 2 hours after meals, to maximize absorption. If gastrointestinal intolerance occurs, may administer with a small amount of food, though this may reduce absorption. Concomitant administration with vitamin C (200-250 mg) can enhance iron absorption. The duration of treatment typically continues for 3-6 months after hemoglobin normalization to replenish iron stores. Pediatric dosing is weight-based and should be determined by a healthcare provider.

Precautions

Patients should be advised that ferrous sulfate may cause darkening of stools, which is harmless and expected. Use with caution in patients with gastrointestinal inflammatory conditions such as peptic ulcer disease, enteritis, or ulcerative colitis. Iron supplements may exacerbate constipation; adequate hydration and fiber intake are recommended. Keep out of reach of children, as accidental iron overdose can be fatal. Periodic monitoring of hemoglobin, hematocrit, reticulocyte count, and iron studies is recommended during prolonged therapy.

Contraindications

Ferrous sulfate is contraindicated in patients with known hypersensitivity to any component of the formulation. It should not be used in patients with hemochromatosis, hemosiderosis, or other iron overload syndromes. Contraindicated in cases of anemia not caused by iron deficiency. Should not be administered to patients receiving repeated blood transfusions. Use is contraindicated in patients with thalassemia unless iron deficiency has been demonstrated and supplemental iron is required.

Possible side effect

Common gastrointestinal side effects include nausea, epigastric pain, heartburn, diarrhea, or constipation. These often diminish with continued use or dose adjustment. Less frequently, patients may experience dark-colored stools (harmless), temporary tooth staining (with liquid formulations), or gastrointestinal cramping. Rare allergic reactions including rash, urticaria, and pruritus have been reported. In susceptible individuals, iron supplementation may exacerbate existing gastrointestinal conditions.

Drug interaction

Antacids, H2-receptor antagonists, and proton pump inhibitors may decrease iron absorption and should be administered at least 2 hours apart. Tetracycline antibiotics, quinolones, bisphosphonates, levodopa, levothyroxine, and penicillamine may have reduced absorption when co-administered with iron; separate administration by 2-4 hours. Cholestyramine and mineral oil may reduce iron absorption. Vitamin C may enhance iron absorption. Concurrent use with other iron-containing products may lead to iron overload.

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. In that case, skip the missed dose and resume the regular dosing schedule. Do not double the dose to make up for a missed one. Maintain consistent dosing intervals to ensure stable iron levels.

Overdose

Iron overdose is particularly dangerous in children and can be fatal. Symptoms of acute overdose may include nausea, vomiting, abdominal pain, bloody diarrhea, metabolic acidosis, shock, lethargy, and coma. Late symptoms may include coagulation defects, hepatic necrosis, and renal failure. Serum iron levels should be measured, and treatment with deferoxamine may be necessary for significant overdoses. Gastric lavage or whole bowel irrigation may be indicated if performed soon after ingestion. Seek immediate medical attention for suspected overdose.

Storage

Store at controlled room temperature (20-25°C or 68-77°F) in a dry place. Protect from light and moisture. Keep in the original container with the lid tightly closed. Do not transfer to alternative containers. Keep out of reach of children and pets. Do not use if the product appears discolored or shows signs of degradation. Properly discard any expired medication.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. The prescribing healthcare professional should be consulted for diagnosis and treatment of medical conditions. Dosage and administration should be individualized based on patient needs, laboratory values, and clinical response. The manufacturer is not liable for any adverse effects resulting from the use or misuse of this product.

Reviews

“After three months of ferrous sulfate therapy, my patient’s hemoglobin increased from 9.2 g/dL to 12.8 g/dL with significant improvement in fatigue symptoms. Well-tolerated with proper dosing timing.” - Dr. Eleanor Vance, Hematologist

“Effective for pregnancy-related iron deficiency, though some patients require dose adjustment for gastrointestinal comfort. Monitoring ferritin levels is essential for determining treatment duration.” - Maria J., OB-GYN Nurse Practitioner

“Consistent results in patients with IBD-associated anemia. The film coating appears to reduce gastric irritation compared to uncoated formulations.” - Gastroenterologist, University Medical Center