Deferiprone

Deferiprone is a chelating agent with an affinity for ferric ions (iron III). Deferiprone binds with ferric ions to form neutral 3:1 (deferiprone:iron) complexes that are stable at physiological pH.

• Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. Deferiprone tablets are an iron chelator indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate.

• Deferiprone is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. The following reactions have been reported in association with the administration of deferiprone: Henoch-Schönlein purpura; urticaria; and periorbital edema with skin rash [see Adverse Reactions (6.2) ].contraindicated

Deferiprone tablets are available in two formulations. A 1,000 mg formulation and a 500 mg formulation, which have different dosing regimens to achieve the same total daily dosage. ( 2.1 ) To prevent medication errors, before prescribing and dispensing, ensure that the tablet formulation is appropriate for the dosing regimen. Each tablet has distinct identifying characteristics. ( 2.1 , 3 ) Deferiprone tablets (three times a day), 1,000 mg: Starting oral dosage: 75 mg/kg/day (actual body weight) in three divided doses ( 2.3 ) Maximum oral dosage: 99 mg/kg/day (actual body weight) in three divided doses ( 2.3 ) Deferiprone tablets (three times a day), 500 mg: Starting oral dosage: 75 mg/kg/day (actual body weight) in three divided doses ( 2.4 ) Maximum oral dosage: 99 mg/kg/day (actual body weight) in three divided doses ( 2.4 ) 2.1 Important Dosage and Administration Information Deferiprone tablets are available in a 1,000 mg formulation and a 500 mg formulation, which have different oral dosing regimens to achieve the same total daily dosage. Deferiprone tablets (three times a day) - 1,000 mg - given three times a day [see Dosage and Administration (2.3) ] Deferiprone tablets - 500 mg - given three times a day [see Dosage and Administration (2.4) ] To prevent medication errors, before prescribing and dispensing, ensure that the tablet formulation is appropriate for the dosing regimen. Each tablet has distinct identifying characteristics [see Dosage Forms and Strengths (3) ].

Liver Enzyme Elevations: Monitor monthly and discontinue for persistent elevations. ( 5.2 ) Zinc Deficiency: Monitor during therapy and supplement for deficiency. ( 5.3 ) Embryo-Fetal Toxicity: Can cause fetal harm. ( 5.4 ) 5.1 Agranulocytosis and Neutropenia Fatal agranulocytosis can occur with deferiprone use. Deferiprone can also cause neutropenia, which may foreshadow agranulocytosis. Measure the absolute neutrophil count (ANC) before starting deferiprone therapy and monitor it regularly while on therapy [see Dosage and Administration (2.1) ] . Reduction in the frequency of ANC monitoring should be considered on an individual patient basis, according to the health care provider's assessment of the patient's understanding of the risk minimization measures required during therapy. Interrupt deferiprone therapy if neutropenia develops (ANC < 1.5 × 10 9 /L). Interrupt deferiprone if infection develops and monitor the ANC frequently. Advise patients taking deferiprone to immediately interrupt therapy and report to their physician if they experience any symptoms indicative of infection. The incidence of agranulocytosis was 1% of patients in pooled clinical trials of 642 patients with thalassemia syndromes. The mechanism of deferiprone-associated agranulocytosis is unknown. Agranulocytosis and neutropenia usually resolve upon discontinuation of deferiprone, but there have been reports of agranulocytosis leading to death. Implement a plan to monitor for and to manage agranulocytosis and neutropenia prior to initiating deferiprone treatment.

The following clinically significant adverse reactions are described below and elsewhere in the labeling: Agranulocytosis and Neutropenia [see Warnings and Precautions (5.1) ] Liver Enzyme Elevations [see Warnings and Precautions (5.2) ] Zinc Deficiency [see Warnings and Precautions (5.3) ] The most common adverse reactions in patients with thalassemia (incidence > 6%) are nausea, vomiting, abdominal pain, arthralgia, ALT increased and neutropenia. (5.1, 6) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reaction information represents the pooled data collected from single arm or active-controlled clinical trials with deferiprone tablets (three times a day). Thalassemia Syndromes The safety of deferiprone was evaluated in the pooled clinical trial database [see Clinical Studies (14.1)] . Patients received deferiprone tablets (three times a day). Deferiprone was administered orally three times a day (total daily dose either 50, 75, or 99 mg/kg), N=642. Among 642 patients receiving deferiprone, 492 (76.6%) were exposed for 6 months or longer and 365 (56.9%) were exposed for greater than one year.

Lactation: Advise not to breastfeed. ( 8.2 ) Pediatric use information is approved for Chiesi USA, Inc.'s FERRIPROX® (deferiprone) tablets. However, due to Chiesi USA, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. 8.1 Pregnancy Risk Summary In animal reproduction studies, oral administration of deferiprone to pregnant rats and rabbits during organogenesis at doses 33% and 49%, respectively, of the maximum recommended human dose (MRHD) resulted in structural abnormalities, embryo-fetal mortality and alterations to growth (see Data ) . The limited available data from deferiprone use in pregnant women are insufficient to inform a drug-associated risk of major birth defects and miscarriage. Based on evidence and developmental toxicity in animal studies, deferiprone can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage is 2 to 4% and 15 to 20%, respectively.

Metabolism

Deferiprone Tablets (three times a day), 1,000 mg and 500 mg The mean C max and AUC of deferiprone was 20 mcg/mL and 50 mcg∙h/mL, respectively, in healthy subjects. The dose proportionality of deferiprone over the approved recommended dosage range is unknown.

No cases of acute overdose have been reported. There is no specific antidote to deferiprone overdose. Neurological disorders such as cerebellar symptoms, diplopia, lateral nystagmus, psychomotor slowdown, hand movements and axial hypotonia have been observed in children treated with 2.5 to 3 times the recommended dose for more than one year. The neurological disorders progressively regressed after deferiprone discontinuation.

• Oct 14, 2011NDANDA021825Chiesi
• Sep 9, 2015NDANDA208030Chiesi
• Feb 8, 2019ANDAANDA208800Taro
• May 19, 2020NDANDA212269Chiesi
• Mar 29, 2021ANDAANDA213239Hikma
• Dec 11, 2025ANDAANDA220132Senores Pharms

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Ferriprox, Tablet, 500 mg (NDC 10122-100-10)To be discontinued
  Sponsor: Chiesi USA, Inc.
  Updated Nov 7, 2025

1. 1Off Label Use98833%
2. 2Death2317.8%
3. 3Sickle Cell Anaemia With Crisis1866.3%
4. 4Agranulocytosis1585.4%
5. 5Nausea1555.2%
6. 6Fatigue1374.6%
7. 7Ill-defined Disorder1254.2%
8. 8Vomiting1234.2%
9. 9Neutropenia1214.1%
10. 10Pyrexia1184.0%
11. 11Prescribed Overdose943.2%
12. 12Arthralgia913.1%
13. 13Diarrhoea913.1%
14. 14Abdominal Discomfort872.9%
15. 15Haemoglobin Decreased872.9%

Recent PubMed references pinned to Deferiprone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Deferiprone mitigates imidacloprid-induced neurotoxicity: Roles of iron chelation, ferroptosis, and ferritinophagy.
  Free radical biology & medicine · 2026 · Hindelah YG, Ghaiad HR, Motawi TK, et al.
  PMID 41819505DOI 10.1016/j.freeradbiomed.2026.03.031
• Efficacy and Safety of Deferiprone for Parkinson's Disease: A Systematic Review and Meta-analysis of Randomized Controlled Trials.
  Clinical neuropharmacology · 2026 · Alla D, Shah D, Ramsundar R, et al.
  PMID 41790482DOI 10.1097/WNF.0000000000000669
• Therapeutic Potential of Deferiprone-Resveratrol Hybrid (DFP-RVT) Against Hepatic Iron Overload in β-Thalassemia Mice: A Proteomic Analysis.
  Biomolecules · 2026 · Maneekesorn S, Yingchutrakul Y, Simanon N, et al.
  PMID 41750406DOI 10.3390/biom16020338
• UGT1A6 variants and deferiprone-induced ADRs: a complication-specific analysis in Iranian thalassemia patients.
  Pharmacogenomics · 2025 · Najaflu M, Neufeld EJ, Mansourian M, et al.
  PMID 41622710DOI 10.1080/14622416.2025.2608573
• A label-free fluorescent probe for deferiprone quantification in exhaled breath condensate utilizing UiO-66 MOF/ferric ions system.
  Scientific reports · 2025 · Sheikh Abdollahzadeh Mamaghani N, Karimzadeh Z, Khoubnasabjafari M, et al.
  PMID 41436556DOI 10.1038/s41598-025-33395-8
• Efficacy and safety of deferiprone for thalassemia: a systematic review and meta-analysis of randomized controlled trials.
  Systematic reviews · 2025 · Wilar G, Suhandi C, Kawahata I, et al.
  PMID 41402903DOI 10.1186/s13643-025-03019-3
• Antagonistic Iron Competition Induced by Iron Chelators Heightens Cuproptosis in Both Tumors and Intratumoral Bacteria.
  Advanced materials (Deerfield Beach, Fla.) · 2026 · Xie Y, Wang J, Han Y, et al.
  PMID 41388701DOI 10.1002/adma.202515904
• Slug Flow Liquid-Liquid Extraction of Deferiprone as Iron Complex Using Natural Deep Eutectic Solvents in a Cross-Flow T-Junction Microfluidic System.
  Langmuir : the ACS journal of surfaces and colloids · 2026 · Rezaei N, Ghanbari S, Bijarchi MA, et al.
  PMID 41077950DOI 10.1021/acs.langmuir.5c03415

The 10 most recently updated of 69 ClinicalTrials.gov registrations naming Deferiprone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy and Safety of the Iron Chelator Deferiprone in Parkinson's Disease
  Completed · Phase 2 · Phase 3 · Interventional · 40 enrolled · University Hospital, Lille
  NCT00943748updated 2026-05-14
• Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes
  Completed · Interventional · 90 enrolled · University Hospital, Lille
  NCT02880033updated 2026-05-14
• Ferritin and Iron Burden in SAH sIRB
  Recruiting · Phase 1 · Phase 2 · Interventional · 66 enrolled · Duke University
  NCT03754725updated 2026-05-08
• Combination of Thalidomide and Hydroxyuria in Transfusion Dependent Thalasemmia
  Completed · Phase 2 · Interventional · 100 enrolled · Pakistan Blood and Marrow Transplant (PBMT) Group
  NCT07292259updated 2026-05-05
• Cardiac MRI-guided Deferiprone Therapy for Acute Myocardial Infarction Patients
  Recruiting · Phase 2 · Interventional · 89 enrolled · Rohan Dharmakumar
  NCT05604131updated 2026-04-08
• Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) Patients
  Completed · Phase 2 · Interventional · 23 enrolled · University Hospital, Lille
  NCT02164253updated 2026-02-20
• Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease
  Completed · Phase 2 · Interventional · 372 enrolled · University Hospital, Lille
  NCT02655315updated 2026-02-05
• Conservative Iron Chelation as a Disease-modifying Strategy in Amyotrophic Lateral Sclerosis
  Completed · Phase 2 · Phase 3 · Interventional · 372 enrolled · University Hospital, Lille
  NCT03293069updated 2025-12-05
• Early Screening and Treatment of Heart Complication in Sickle Cell Disease
  Recruiting · Phase 2 · Interventional · 100 enrolled · Inova Health Care Services
  NCT07023666updated 2025-10-14
• Iron Chelation in the Prevention of Secondary Degeneration After Stroke
  Terminated · Phase 2 · Interventional · 11 enrolled · University Hospital, Bordeaux
  NCT05111821updated 2025-07-21

Frequently asked questions

How does Deferiprone work?

Deferiprone is a chelating agent with an affinity for ferric ions (iron III). Deferiprone binds with ferric ions to form neutral 3:1 (deferiprone:iron) complexes that are stable at physiological pH.

What is Deferiprone used for?

According to FDA labeling, Deferiprone carries indications including: Deferiprone tablets are indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate. Deferiprone tablets are an iron chelator indicated for the treatment of transfusional iron overload in adult patients with thalassemia syndromes when current chelation therapy is inadequate.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Deferiprone?

Deferiprone is classified as Iron chelating agents, Iron Chelator, Iron Chelating Activity.

What are the brand names for Deferiprone?

Deferiprone is marketed under brand names including Ferriprox.

What are the contraindications for Deferiprone?

Deferiprone labeling lists contraindications including: Deferiprone is contraindicated in patients with known hypersensitivity to deferiprone or to any of the excipients in the formulations. The following reactions have been reported in association with the administration of deferiprone: Henoch-Schönlein purpura; urticaria; and periorbital edema with skin rash [see Adverse Reactions (6.2) ].. Always consult the full prescribing information and a clinician.