Pharmacologic class (EPC) · 5 drug pages

Iron chelator: adverse event reports filed with FDA

26,165 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

26,165
reports across the class: 0.1% of all reports; 512
reports, 12 months to June 2026: 559 in the 12 months before; 85.9%
marked serious by the reporter: 57.4% across all reports; 5
drugs with a page: brand and generic names counted separately

Iron chelator is a pharmacologic class (an FDA Established Pharmacologic Class) with 5 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 26,165 adverse event reports received by FDA, 0.1% of the database, from March 2004 to June 2026.

512 reports arrived in the 12 months to June 2026, close to the 559 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 85.9% of the class's reports are marked serious, 28.4% record death among the outcomes and 36.9% record hospitalisation, as reported.

Across the class the reactions recorded most often are death (18.1%), diarrhoea (8.6%) and sickle cell anaemia with crisis (6.3%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
ExjadeDeferasirox	brand	18,309	30	91.9%	Death
JadenuDeferasirox	brand	2,848	16	61.3%	Death
FerriproxDeferiprone	brand	2,351	296	65%	Off label use
Deferasirox	generic	1,810	157	87.5%	Sickle cell anaemia with crisis
DesferalDeferoxamine mesylate	brand	847	13	93.2%	Serum ferritin increased

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Deaththe patient died; cause not stated by this term18.1%4,732
Diarrhoealoose or frequent stools8.6%2,239
Sickle cell anaemia with crisis6.3%1,643
Nauseafeeling sick5.4%1,420
Pyrexiafever5.2%1,369
Serum ferritin increased4.9%1,283
Haemoglobin decreasedlow haemoglobin4.7%1,230
Vomitingbeing sick4.3%1,135
Malaisegeneral feeling of being unwell4.2%1,088
Pneumonialung infection4.1%1,078
Off label useused for a purpose or in a way not on the label4.1%1,074
Fatiguetiredness3.8%991
Abdominal painstomach or belly pain3.4%901
Painpain, site not specified3.3%876
Blood creatinine increasedraised creatinine, a kidney test3.2%829
Astheniaweakness or lack of energy2.9%765
Dyspnoeashortness of breath2.8%721
Abdominal pain upperupper stomach pain2.6%669
Platelet count decreasedlow platelet count2.4%641
Anaemialow red blood cells2.4%617
Rashskin rash2.3%591
Headachehead pain2.2%579
Abdominal discomfortstomach discomfort2.1%557
Renal failurekidney failure2.1%542
Weight decreasedweight loss2%525

Solid bar: share of all class reports. Hollow bar: the median share across the 5 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death28.4%7,428

Life-threatening2.7%702

Hospitalisation (initial or prolonged)36.9%9,653

Disability1.2%310

Congenital anomaly0.1%17

Other serious37.9%9,922

Not serious14.1%3,695

Patient age

Under 20.1%29

2 to 114.4%1,161

12 to 173%796

18 to 4412.1%3,168

45 to 648.8%2,305

65 to 747.5%1,967

75 and over9.9%2,590

Age not given54.1%14,149

Who reported

Physician23.4%6,113

Pharmacist9.1%2,379

Other health professional18.6%4,871

Lawyer0%2

Consumer or non-health professional32.1%8,412

Not given16.8%4,388

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Iron chelator reports

Which drugs are in the Iron chelator class on this site?

Exjade, Jadenu, Ferriprox, Deferasirox and Desferal. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

26,165 reports through June 2026, 512 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

death (18.1%), diarrhoea (8.6%), sickle cell anaemia with crisis (6.3%), nausea (5.4%) and pyrexia (5.2%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.