Brand name · Deferasirox
Exjade: adverse event reports filed with FDA
18,309 reports list it as a suspect or interacting product, 2005–2026. Class: Iron chelator.
- 18,309
- reports as suspect product
- 0.1% of all reports · about 879 a year
- 30
- reports, 12 months to June 2026
- 48 in the 12 months before
- 91.9%
- marked serious by the reporter
- 85.9% across the class
- 34%
- record death among outcomes, as reported
- 6,219 reports · not verified by FDA
18,309 adverse event reports received by FDA list the brand name Exjade (deferasirox) as a suspect or interacting product, from September 2005 to June 2026. A further 1,827 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 30 reports listed it, down 37% from 48 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 879 reports a year and 0.1% of the 20,646,523 reports in the database, and 70% of the reports for the iron chelator class. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are death (21.5%), diarrhoea (9.8%) and sickle cell anaemia with crisis (6.7%). A report can list several reactions, so shares add to more than 100%; 1,589 different terms appear across these reports. Death is recorded in 21.5% of these reports, a larger share than in the median iron chelator drug (7.5%).
91.9% of the reports are marked serious by the reporter (85.9% across the class); 34% record death among the outcomes and 37.5% record hospitalisation, as reported. 28.7% of the reports came from consumers, and the largest patient age group is 75 and over (10.4%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Exjade reports recording the termmedian drug in iron chelator
- Deaththe patient died; cause not stated by this term21.5%3,938
- Diarrhoealoose or frequent stools9.8%1,792
- Sickle cell anaemia with crisis6.7%1,226
- Nauseafeeling sick5.8%1,060
- Pyrexiafever5.8%1,056
- Serum ferritin increased5.3%979
- Haemoglobin decreasedlow haemoglobin5.1%939
- Pneumonialung infection5%915
- Malaisegeneral feeling of being unwell5%910
- Vomitingbeing sick4.5%825
- Painpain, site not specified3.9%716
- Fatiguetiredness3.9%711
- Blood creatinine increasedraised creatinine, a kidney test3.8%699
- Abdominal painstomach or belly pain3.7%673
- Astheniaweakness or lack of energy3.3%603
- Dyspnoeashortness of breath3.1%570
- Platelet count decreasedlow platelet count2.9%525
- Abdominal pain upperupper stomach pain2.8%504
- Anaemialow red blood cells2.6%475
- Rashskin rash2.5%461
- Renal failurekidney failure2.5%452
- Headachehead pain2.4%434
- Weight decreasedweight loss2.3%420
- Infectionan infection, type not specified2.2%408
- Dizzinesslight-headedness or unsteadiness2%372
- Abdominal discomfortstomach discomfort2%366
- Sepsisa severe body-wide response to infection2%363
- Decreased appetitereduced appetite1.9%341
- Falla fall1.8%328
- Pain in extremitypain in an arm or leg1.8%326
Top 30 of 1,589 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the iron chelator class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 26,165 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 65.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Iron overload | 4,062 | 22.2% |
| Myelodysplastic syndrome | 2,450 | 13.4% |
| Sickle cell anaemia | 1,642 | 9% |
| Haemochromatosis | 431 | 2.4% |
| Thalassaemia | 415 | 2.3% |
| Iron metabolism disorder | 332 | 1.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 18,309 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Exjade reports |
|---|---|---|
| Folic acid | 1,174 | 6.4% |
| Aspirin | 452 | 2.5% |
| Lasix | 366 | 2% |
| Hydroxyurea | 314 | 1.7% |
| Hydrea | 304 | 1.7% |
| Allopurinol | 257 | 1.4% |
| Vitamin d | 241 | 1.3% |
| Omeprazole | 234 | 1.3% |
| Prednisone | 231 | 1.3% |
| Furosemide | 203 | 1.1% |
Other products listed in reports where Exjade is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Exjade | Iron chelator | All reports |
|---|---|---|---|
| Reports as suspect product | 18,309 | 26,165 | 20,646,523 |
| Share of that pool | — | 70% | 0.1% |
| Reports, latest 12 months | 30 | — | 1,332,454 |
| Marked serious | 91.9% | 85.9% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 340 | 284 | 91 |
| Hospitalisation recorded, per 1,000 reports | 375 | 369 | 213 |
| Consumer-filed share | 28.7% | 32.1% | 45.8% |
| Top term, share of reports | Death 21.5% | median 7.5% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the iron chelator class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Jadenu | brand | 2,848 | 16 | 61.3% |
| Ferriprox | brand | 2,351 | 296 | 65% |
| Deferasirox | generic | 1,810 | 157 | 87.5% |
| Desferal | brand | 847 | 13 | 93.2% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Exjade reports
How many adverse event reports has FDA received for Exjade?
18,309 reports list Exjade as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 30 of them arrived in the latest 12 months. Another 1,827 list it only as a concomitant medication.
What reactions are recorded in Exjade reports?
death (21.5%), diarrhoea (9.8%), sickle cell anaemia with crisis (6.7%), nausea (5.8%) and pyrexia (5.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Exjade was responsible.
How serious are the reports?
91.9% are marked serious by the reporter. Among the outcomes recorded, 34% of reports include death and 37.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (28.7%), physician (26.4%) and not given (21.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Exjade rising?
30 reports in the 12 months to June 2026, down 37% from 48 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Exjade was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Exjade?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Exjade as a suspect or interacting product; reports listing it only as a concomitant medication (1,827) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.