What the label lists and what reports show
Deferasirox side effects
Deferasirox's FDA label lists its adverse reactions in its own words. FAERS holds 26,369 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 diarrhoea (2,343 reports).
- Generic listed
- Boxed warning
Check it at the source: the deferasirox FDA label on DailyMed (effective January 28, 2026, Novartis Pharmaceuticals Corporation); 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 Exjade?Exjade can cause serious side effects, including: See "What is the most important information I should know about Exjade?" Effects on your bone marrow. Exjade can affect your bone marrow and cause you to have a low white blood cell count which can be serious, decreased platelets, or worsening of your anemia, and may lead to death. Your risk for effects on your bone marrow may be increased if you already have other blood disorders. Your healthcare provider will do blood tests to monitor your blood cell counts for these problems. Serious allergic reactions. Exjade may cause serious allergic reactions, which usually start within the first month of treatment. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective January 28, 2026 (SPL set 3495a70c-870c-4968-940e-8baea152cf85), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following clinically significant adverse reactions are also discussed in other sections of the labeling: Acute Kidney Injury, Including Acute Renal Failure Requiring Dialysis, and Renal Tubular Toxicity Including Fanconi Syndrome [see Warnings and Precautions (5.1, 5.6)] Hepatic Toxicity and Failure [see Warnings and Precautions (5.2, 5.6)] GI Hemorrhage [see Warnings and Precautions (5.3)] Bone Marrow Suppression [see Warnings and Precautions (5.4)] Hypersensitivity [see Warnings and Precautions (5.7)] Severe Skin Reactions [see Warnings and Precautions (5.8)] Skin Rash [see Warnings and Precautions (5.9)] Auditory and Ocular Abnormalities [see Warnings and Precautions (5.10)] In patients with transfusional iron overload, the most frequently occurring (greater than 5%) adverse reactions are diarrhea, vomiting, nausea, abdominal pain, skin rashes, and increases in serum creatinine. …
Table 1. Adverse Reactions a Occurring in Greater Than 5% of Exjade-treated Patients in Study 1, Study 3, and MDS Pool
| Adverse Reactions | Exjade N = 296 n (%) | Deferoxamine N = 290 n (%) | Exjade N = 132 n (%) | Deferoxamine N = 63 n (%) | Exjade N = 627 n (%) |
|---|---|---|---|---|---|
| Abdominal Pain b | 63 (21) | 41 (14) | 37 (28) | 9 (14) | 145 (23) |
| Diarrhea | 35 (12) | 21 (7) | 26 (20) | 3 (5) | 297 (47) |
| Creatinine Increased c | 33 (11) | 0 (0) | 9 (7) | 0 | 89 (14) |
| Nausea | 31 (11) | 14 (5) | 30 (23) | 7 (11) | 161 (26) |
| Vomiting | 30 (10) | 28 (10) | 28 (21) | 10 (16) | 83 (13) |
| Rash | 25 (8) | 9 (3) | 14 (11) | 3 (5) | 83 (13) |
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.
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective January 28, 2026 (SPL set 3495a70c-870c-4968-940e-8baea152cf85), via openFDA; the full label on DailyMed
What do FAERS reports show?
26,369 reports list deferasirox among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7,717 are coded as a death and 10,069 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 23 reactions below, 11 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?
- Deferasirox: 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