Clinical beta

FMBM is currently in clinical beta. Content is for professional review/testing and must not replace local protocols, senior clinical judgment, or official prescribing references.

Drug Monograph

Ferrous-Sulfate

USE IF: Iron deficiency anemia, iron deficiency states, prevention in selected high-risk patients

AVOID IF: Iron overload states, anemia without confirmed iron deficiency

Ferrous sulfate

Oral iron (heme synthesis support) for iron repletion

AdultPediatricHematologyIron deficiencyHigh-yieldOutpatient

Indication

Iron deficiency anemia • Iron deficiency states

At a glance

INDICATIONS (CORE USE)

- Iron deficiency anemia - Iron deficiency without anemia (selected)

ADULT DOSE (STANDARD)

Typically 100-200 mg elemental iron daily Use divided or alternate-day dosing depending on tolerance

MAX DOSE

Avoid excessive dosing; absorption plateaus and side effects increase

Route

PO

PEDIATRIC DOSE

Protocol-based

Do not miss

Must-not-miss safety points

Major warning

- Do NOT treat anemia without confirming iron deficiency - Poor absorption reduces effectiveness (food, PPIs, calcium) - GI side effects are a major cause of non-adherence - Continue treatment after hemoglobin normalizes to replenish iron stores

Indications

INDICATION: Iron deficiency anemia • Iron deficiency states

Primary

  • Iron deficiency anemia

Secondary

  • Iron deficiency states (without anemia)

Dosing

STANDARD (ADULT PO)

Elemental iron dosing preferred (not just tablet strength); daily or alternate-day regimens based on tolerance

ADULT DOSE

STANDARD (ADULT): - Typically 100-200 mg elemental iron daily - Daily or alternate-day dosing depending on tolerance

PEDIATRIC DOSE

Protocol-based

MAX DOSE

Avoid excessive dosing; limited additional absorption and higher GI adverse effects

Practical Note

- Absorption is better on an empty stomach, but GI intolerance may increase - Alternate-day dosing may improve tolerance and absorption - Adjust regimen based on response and adherence

Warnings

Clinical warnings

  • GI irritation (nausea, constipation)
  • Dark stools are common and usually benign but may concern patients
  • Overuse can cause iron overload in inappropriate cases

Adverse effects

  • Nausea
  • Constipation
  • Abdominal discomfort

Contraindications

  • Iron overload states (e.g., hemochromatosis)
  • Non-iron deficiency anemia

Drug interactions

  • PPIs / antacids reduce iron absorption
  • Calcium products reduce absorption
  • Binding interactions with tetracyclines and quinolones reduce effectiveness of both agents

Special populations

Pediatrics

Protocol-based

Pregnancy

Pregnancy: Commonly required supplementation for iron deficiency risk or confirmed deficiency

Lactation

Compatible in usual oral replacement dosing; monitor maternal tolerance and adherence.

Renal impairment

Protocol-based adjustment and monitoring in chronic kidney disease pathways.

Hepatic impairment

No routine hepatic dose adjustment; monitor for alternative causes of anemia if response is poor.

Elderly

Monitor GI tolerance, adherence, and causes of occult blood loss.

Administration

- Oral dosing - Take on an empty stomach if tolerated - Take with food when GI intolerance limits adherence - Separate from calcium, antacids, and other interacting medications

Monitoring

  • Monitor: - Hemoglobin / CBC - Clinical symptoms - Tolerance and adherence
  • Recheck: - Hemoglobin response in 2-4 weeks - Continue therapy for months until iron stores are replenished
  • Hold / reassess: - No response: reassess diagnosis, absorption barriers, blood loss, and adherence - Intolerance: adjust schedule, timing, or formulation

Overdose / toxicity

Clinical Picture

GI toxicity (nausea, vomiting, abdominal pain); severe overdose can cause systemic toxicity, especially in children

Immediate Actions

Urgent evaluation for any suspected significant overdose; involve poison center/toxicology early

Antidote

Chelation (e.g., deferoxamine) in severe iron toxicity

Decontamination

Per poison center or toxicology guidance; do not delay escalation in symptomatic patients

Escalation

Escalate urgently for pediatric ingestion, systemic symptoms, metabolic acidosis, shock, or altered mental status

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield

  • Dose by elemental iron, not tablet strength
  • Continue treatment after hemoglobin normalizes to refill stores

Clinical

  • Alternate-day dosing can improve absorption and tolerability
  • Adherence barriers (GI effects, timing complexity) often drive failure

Safety

  • Most common error is treating anemia without confirming iron deficiency
  • Suspected overdose in children requires urgent evaluation

Pharmacy Tool

Preparation Calculator

Ferrous sulfate 15 mg/mL oral suspension

suspension · oral

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Pharmacokinetics

- Oral absorption is variable and strongly affected by food and gastric environment

Mechanism of action

- Replaces iron required for hemoglobin synthesis and erythropoiesis

Common brand names

Saudi Arabia

Feroglobin, Fefol, Ironorm

Global

Feosol, Ferrous sulfate, Oral iron, (placeholder — verify local formulation)

Common trade names are curated examples only — formulations and availability vary. Verify the exact product name with your local pharmacy and national regulator before prescribing or dispensing.

Country practice notes

Global data (no country-specific data available)

  • Follow local antimicrobial stewardship policy, hospital formulary, and national resistance guidance.
  • Confirm dosing, stock, and restrictions with institutional pharmacy and current product labeling.

References

Saudi Arabia

  • SFDA (Saudi Food & Drug Authority)
  • Saudi National Formulary / MOH (where available)

International

  • WHO Model List of Essential Medicines (verify current edition)
  • US FDA or EU EMA product information (when national SmPC is unavailable)
  • Product labeling (ferrous sulfate)
  • Local hematology / primary-care anemia protocols