Efficacy, Safety, and Tolerability of Ferric Carboxymaltose and Iron Sucrose in Iron-Deficiency Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

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#humans #anemia-iron-deficiency #ferric-compounds #maltose #ferric-oxide-saccharated

Efficacy, Safety, and Tolerability of Ferric Carboxymaltose and Iron Sucrose in Iron-Deficiency Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Tanrıverdi et al., 2025 | Turk J Haematol | Meta Analysis

Citation

Tanrıverdi Lokman Hekim, Sarıcı Ahmet. Efficacy, Safety, and Tolerability of Ferric Carboxymaltose and Iron Sucrose in Iron-Deficiency Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Turk J Haematol. 2025-May-22;42(2):119-135. doi:10.4274/tjh.galenos.2025.2025.0034

Abstract

OBJECTIVE: This study comprehensively compares the efficacy, safety, and tolerability of two commonly used intravenous iron preparations, ferric carboxymaltose (FCM) and iron sucrose (IS), in adult patients with iron-deficiency anemia (IDA). MATERIALS AND METHODS: A systematic literature search was conducted across the PubMed, Ovid MEDLINE, Web of Science, and Cochrane Library databases up to January 1, 2024, to identify randomized controlled trials directly comparing FCM and IS treatments in adult patients with IDA. The primary outcome of interest was change in hemoglobin (Hb) levels during follow-up. Meta-analyses were conducted with inverse variance random effects models. RESULTS: Fourteen trials were included in the study, with a total of 4757 patients. FCM resulted in a non-significant increase in Hb levels (mean difference [MD]: 0.45 g/dL, 95% confidence interval [CI]: 0.08 to 0.83, p=0.02) and ferritin levels (MD: 37.32 ng/mL, 95% CI: 18.98 to 55.65, p<0.01) compared to IS. FCM was associated with a higher risk of hypersensitivity reactions compared to IS (relative risk [RR]: 2.97, 95% CI: 1.35 to 6.52, p<0.01) but showed no significant difference in severe adverse events (RR: 1.03, 95% CI: 0.88 to 1.21, p=0.70) and had a non-significant increased risk of hypophosphatemia (RR: 2.84, 95% CI: 0.89 to 9.06, p=0.08). CONCLUSION: Ten studies showed some concerns of risk of bias (RoB) and four studies had a high RoB for the change in Hb levels during follow-up. The lack of standardized definitions for hypersensitivity reactions and variability in dosing protocols and follow-up durations across studies may affect the generalizability of our safety findings.

Key Findings

Fourteen trials were included in the study, with a total of 4757 patients. FCM resulted in a non-significant increase in Hb levels (mean difference [MD]: 0.45 g/dL, 95% confidence interval [CI]: 0.08 to 0.83, p=0.02) and ferritin levels (MD: 37.32 ng/mL, 95% CI: 18.98 to 55.65, p<0.01) compared to IS. FCM was associated with a higher risk of hypersensitivity reactions compared to IS (relative risk [RR]: 2.97, 95% CI: 1.35 to 6.52, p<0.01) but showed no significant difference in severe adverse ev

Outcomes Measured

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Population

Field Value
Population adult patients
Sample Size 4757
Age Range See abstract
Condition deficiency

MeSH Terms

  • Humans
  • Anemia, Iron-Deficiency
  • Ferric Compounds
  • Maltose
  • Ferric Oxide, Saccharated
  • Randomized Controlled Trials as Topic
  • Treatment Outcome
  • Hemoglobins
  • Hematinics

Evidence Classification

  • Level: Meta Analysis
  • Publication Types: Journal Article, Systematic Review, Meta-Analysis
  • Vertical: iron

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09