Drug Safety Information for EXJADE (Deferasirox)

FDA Safety-related Labeling Changes for EXJADE (DEFERASIROX) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for JADENU (DEFERASIROX) Rx Drug: Safety Information Link

FDA Safety-related Labeling Changes for JADENU SPRINKLE (DEFERASIROX) Rx Drug: Safety Information Link

Required post-approval safety study:

Establish a registry of children (aged 10 to <18 years old at enrollment) with NTDT and treated with Exjade� (deferasirox) for documented iron overload. Study 2422 will follow at least 40 children for up to 5 years to assess and analyze the long-term safety of treatment with Exjade� (deferasirox), including an assessment of growth, compared to children on a regular transfusion program receiving Exjade� (deferasirox) (based on historical data). Provide annual interim reports on enrollment and outcomes. Due Date: 2021-12-31

Original FDA Drug Approval Date for EXJADE: 2005-11-02

Adverse Drug Reactions for EXJADE* (Deferasirox)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with EXJADE
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Death	4034
2	Diarrhoea	1495
3	Sickle cell anaemia with crisis	1122
4	Pyrexia	972
5	Nausea	862
6	Pneumonia	860
7	Haemoglobin decreased	811
8	Blood creatinine increased	700
9	Vomiting	642
10	Fatigue	630
11	Serum ferritin increased	625
12	Malaise	567
13	Abdominal pain	558
14	Pain	545
15	Neoplasm malignant	533
16	Dyspnoea	519
17	Platelet count decreased	491
18	Asthenia	478
19	Anaemia	475
20	Rash	450

* This side effect also appears in "Top 10 Side Effects of EXJADE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking EXJADE
(associated with FDA Medwatch/FAERS Reports)

	Reason	# of FDA Reports
1	Iron overload*	17838
2	Myelodysplastic syndrome	6831
3	Sickle cell anaemia	4979
4	Blood iron increased	1851
5	Product used for unknown indication	1588
6	Haemochromatosis	1435
7	Thalassaemia beta	1301
8	Thalassaemia	1193
9	Haemosiderosis	1079
10	Iron metabolism disorder	878

*Also a top-10 reason in AskaPatient Review Summary.

Types of Adverse Events for EXJADE

Total Reports Filed with FDA: 59646

Number of FDA Adverse Event Reports by Patient Age for EXJADE

Total Reports Filed with FDA: 59646*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Deferasirox (Jadenu, Icl670, Icl670a, Exjade)

Charts are based on 59646 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.