What the label lists and what reports show
Deferiprone side effects
Deferiprone's FDA label: “The most common adverse reactions in patients with thalassemia (incidence ≥ 6%) are nausea, vomiting, abdominal pain, arthralgia, ALT increased and neutropenia.” FAERS holds 3,004 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is sickle cell anaemia with crisis (191 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the deferiprone FDA label on DailyMed (effective May 1, 2025, Hikma Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of deferiprone tablets?Deferiprone tablets can cause serious side effects, including: • See “What is the most important information I should know about deferiprone tablets?” • Increased liver enzyme levels in your blood. Your healthcare provider should do blood tests to check your liver function before you start and then monthly during treatment with deferiprone tablets. Your healthcare provider may temporarily stop treatment with deferiprone tablets if you develop increased liver enzyme levels and they continue to be increased. • Decreased levels of zinc in your blood. Your healthcare provider will do blood tests to check your zinc levels before you start and during treatment with deferiprone tablets, and may prescribe a zinc supplement for you if your zinc levels are low. […]
Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective May 1, 2025 (SPL set d7ea0a84-c328-4636-8cd6-ad75f2074b22), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions in patients with thalassemia (incidence ≥ 6%) are nausea, vomiting, abdominal pain, arthralgia, ALT increased and neutropenia.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Body System Adverse Reaction | (N=642) % Patients BLOOD AND LYMPHATIC SYSTEM DISORDERS |
|---|---|
| Neutropenia Neutropenia includes events of severe neutropenia (ANC ≥ 0.2 x 10 9 /L and <… | 7 |
| Agranulocytosis Agranulocytosis (ANC < 0.2 x 10 9 /L) | 1 |
| Nausea | 13 |
| Abdominal pain/discomfort | 10 |
| Vomiting | 10 |
| Diarrhea | 3 |
| Dyspepsia | 2 |
| Alanine aminotransferase increased | 7 |
| Weight increased | 2 |
| Aspartate aminotransferase increased | 1 |
| Increased appetite | 4 |
| Decreased appetite | 1 |
| Arthralgia | 10 |
| Back pain | 2 |
| Pain in extremity | 2 |
| Arthropathy | 1 |
| Headache | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe 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 Hikma Pharmaceuticals USA Inc. at 1-800-962-8364 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 tablets was evaluated in the pooled clinical trial database [see Clinical Studies ( 14.1 )]. Patients received deferiprone tablets (three times a day). …
Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective May 1, 2025 (SPL set d7ea0a84-c328-4636-8cd6-ad75f2074b22), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,004 reports list deferiprone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 371 are coded as a death and 1,193 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Deferiprone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions