Prescription medicine
Deferasirox Brand names: Jadenu, Exjade
Deferasirox (Jadenu) is a prescription medicine with an FDA approval on record since 2005. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $1.25 per deferasirox 360 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the deferasirox FDA label on DailyMed (effective January 28, 2026, Novartis Pharmaceuticals Corporation); the NDA 21882 record on Drugs@FDA; every deferasirox label on DailyMed.
Highlights of the record
FDA label of January 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RENAL FAILURE, HEPATIC FAILURE,.
and GASTROINTESTINAL HEMORRHAGE Renal Failure Exjade can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders. Evaluate baseline renal function prior to starting or increasing Exjade dosing in all patients. Exjade is contraindicated in adult and pediatric patients with eGFR less than 40 mL/min/1.73 m 2 . Measure serum creatinine in duplicate prior to initiation of therapy. Monitor renal function at least monthly. For patients with baseline renal impairment or increased risk of acute renal failure, monitor renal function weekly for the first month, then at least monthly. Reduce the starting dose in patients with preexisting renal disease. During therapy, increase the frequency of monitoring and modify the dose for patients with an increased risk of renal impairment, including use of concomitant nephrotoxic drugs, and pediatric patients with volume depletion or overchelation [see Dosage and Administration (2.1, 2.4, 2.5), Warnings and Precautions (5.1), Adverse Reactions (6.1, 6.2)]. Hepatic Failure Exjade can cause hepatic injury including hepatic failure and death. Measure serum transaminases and bilirubin in all patients prior to initiating treatment, every 2 weeks during the first month, and at least monthly thereafter. […]
Used for
From the label: indications and usageExjade is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older.
Forms and strengths
- 90 mg
- 125 mg
- 180 mg
- 250 mg
- 360 mg
- 500 mg
Tablet for suspension; film-coated tablet; granule; tablet.
On the market
- Earliest approval on file
- November 2, 2005 Exjade, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 35 first January 26, 2016; 25 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 21 of which 20 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- November 21, 2034 Jadenu tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.25 per tablet Deferasirox 360 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2023 0 Class I among all firms' recalls; latest October 20, 2023
- FAERS reports
- 26,369 through July 30, 2026
What is deferasirox used for?
From the label: indications and usageExjade is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. ( 1.1 ) Exjade is indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (NTDT) syndromes, and with a liver iron (Fe) concentration (LIC) of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L. ( 1.2 ) Limitations of Use: The safety and efficacy of Exjade when administered with other iron chelation therapy have not been established. […]
FDA pharmacologic class: Iron Chelator.
Source: FDA drug label (Exjade), Novartis Pharmaceuticals Corporation, effective January 28, 2026 (SPL set 3495a70c-870c-4968-940e-8baea152cf85), via openFDA; the full label on DailyMed
What does the patient leaflet for deferasirox say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Exjade?Exjade can cause serious side effects, including: Kidney problems. Exjade can cause sudden (acute) kidney problems, including kidney failure that may require treatment with dialysis, and may cause death. Deaths have happened mostly in people who also have other health problems and had a blood disorder that was in an advanced stage. Adults and children who already have kidney problems and are taking certain medicines with Exjade may also have an increased risk of sudden kidney problems. Be sure to tell your healthcare provider about all the medicines you take during treatment with Exjade. Your healthcare provider should do blood and urine tests to check your or your child’s kidney function before and during treatment with Exjade. Call your or your child’s healthcare provider right away if: your child becomes sick with fever, vomiting, or diarrhea and cannot drink fluids normally during treatment with Exjade. Your child may be dehydrated. Your child’s healthcare provider may need to temporarily stop treatment with Exjade and treat your child for dehydration to help prevent kidney problems. Your child’s healthcare provider may monitor your child’s kidney function more closely. you notice that you or your child are passing less urine than usual during treatment with Exjade. Liver problems. Exjade can cause liver problems, including liver failure that can sometimes cause death. Liver problems with Exjade may be more common in people who are over 55 years of age but can also happen in children. Liver failure has happened more often in people with cirrhosis of the liver and failure of other organs. Liver failure has also happened along with kidney problems in certain children who become dehydrated. See “Kidney problems” above. […]
From the patient leaflet: What should I avoid while taking Exjade?Exjade may cause dizziness. Avoid driving or operating machinery until you know how Exjade affects you. Do not drive or operate machinery if Exjade makes you dizzy.
From the patient leaflet: How should I store Exjade?Store Exjade at room temperature between 68°F to 77°F (20°C to 25°C). Keep the bottle closed tightly and away from moisture. Keep Exjade and all medicines out of the reach of children.
Source: FDA drug label (Exjade), Novartis Pharmaceuticals Corporation, effective January 28, 2026 (SPL set 3495a70c-870c-4968-940e-8baea152cf85), via openFDA; the full label on DailyMed
Is there a generic for deferasirox (Jadenu)?
The FDA approved the first generic deferasirox on January 26, 2016. 35 generic applications are approved; 25 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists deferasirox from 20 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Jadenu tablets: the compound patent runs to November 21, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2005 earliest approval on file
- 2016 first generic approved
- 2034 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for deferasirox (Jadenu)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.25 per Deferasirox 360 mg tablet, down 2% from $1.27 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Deferasirox 360 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Deferasirox 180 mg tablet | Generic | $0.875 per tablet | $26.25 | no change |
| Deferasirox 360 mg tablet | Generic | $1.25 per tablet | $37.42 | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has deferasirox been recalled?
The FDA's Enforcement Report lists 1 recall naming deferasirox since 2023: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 20, 2023 | Class II | Glenmark Pharmaceuticals Inc., USA | Failed Dissolution Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the deferasirox label say about other medicines?
The deferasirox label names 47 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name deferasirox. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Alosetron | drug interactions | Metabolized by CYP1A2 Deferasirox inhibits CYP1A2 resulting in an increase in CYP1A2 substrate (e.g., alosetron, caffeine, duloxetine, melatonin, ramelteon, tacrine, theophylline, tizanidine) concentration when these drugs are coadministered. |
| Aprepitant | drug interactions | Closely monitor patients for signs of reduced effectiveness when deferasirox is administered with drugs metabolized by CYP3A4 (e.g., alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine … |
| Budesonide | drug interactions | Closely monitor patients for signs of reduced effectiveness when deferasirox is administered with drugs metabolized by CYP3A4 (e.g., alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine … |
| Buspirone | drug interactions | Closely monitor patients for signs of reduced effectiveness when deferasirox is administered with drugs metabolized by CYP3A4 (e.g., alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine … |
| Busulfan | drug interactions | Consider repaglinide dose reduction and monitor blood glucose levels. ( 7.3 ) Avoid the use of Exjade with CYP1A2 substrate theophylline. ( 7.4 ) Deferasirox increases exposure of busulfan. |
| Caffeine | drug interactions | Metabolized by CYP1A2 Deferasirox inhibits CYP1A2 resulting in an increase in CYP1A2 substrate (e.g., alosetron, caffeine, duloxetine, melatonin, ramelteon, tacrine, theophylline, tizanidine) concentration when these drugs are coadministered. |
| Cholestyramine | drug interactions | Avoid the concomitant use of bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol) with Exjade due to a possible decrease in deferasirox concentration. |
| Colesevelam | drug interactions | Avoid the concomitant use of bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol) with Exjade due to a possible decrease in deferasirox concentration. |
| Colestipol | drug interactions | Avoid the concomitant use of bile acid sequestrants (e.g., cholestyramine, colesevelam, colestipol) with Exjade due to a possible decrease in deferasirox concentration. |
| Cyclosporine | drug interactions | Closely monitor patients for signs of reduced effectiveness when deferasirox is administered with drugs metabolized by CYP3A4 (e.g., alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine … |
| Darifenacin | drug interactions | Closely monitor patients for signs of reduced effectiveness when deferasirox is administered with drugs metabolized by CYP3A4 (e.g., alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine … |
| Darunavir | drug interactions | Closely monitor patients for signs of reduced effectiveness when deferasirox is administered with drugs metabolized by CYP3A4 (e.g., alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine … |
| Dasatinib | drug interactions | Closely monitor patients for signs of reduced effectiveness when deferasirox is administered with drugs metabolized by CYP3A4 (e.g., alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine … |
| Dihydroergotamine | drug interactions | Closely monitor patients for signs of reduced effectiveness when deferasirox is administered with drugs metabolized by CYP3A4 (e.g., alfentanil, aprepitant, budesonide, buspirone, conivaptan, cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine … |
Every other medicine the deferasirox label names
| Medicine named | Section | What the label says |
|---|---|---|
| Dronedarone | drug interactions | … cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine, everolimus, felodipine, fentanyl, hormonal contraceptive agents, indinavir … |
| Duloxetine | drug interactions | Metabolized by CYP1A2 Deferasirox inhibits CYP1A2 resulting in an increase in CYP1A2 substrate (e.g., alosetron, caffeine, duloxetine, melatonin, ramelteon, tacrine, theophylline, tizanidine) … |
| Eletriptan | drug interactions | … darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine, everolimus, felodipine, fentanyl, hormonal contraceptive agents, indinavir, fluticasone … |
| Eplerenone | drug interactions | … darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine, everolimus, felodipine, fentanyl, hormonal contraceptive agents, indinavir, fluticasone, lopinavir … |
| Ergotamine | drug interactions | … conivaptan, cyclosporine, darifenacin, darunavir, dasatinib, dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine, everolimus, felodipine, fentanyl, hormonal contraceptive agents … |
| Everolimus | drug interactions | … dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine, everolimus, felodipine, fentanyl, hormonal contraceptive agents, indinavir, fluticasone, lopinavir, lovastatin, lurasidone … |
| Felodipine | drug interactions | … dihydroergotamine, dronedarone, eletriptan, eplerenone, ergotamine, everolimus, felodipine, fentanyl, hormonal contraceptive agents, indinavir, fluticasone, lopinavir, lovastatin, lurasidone … |
| Fentanyl | drug interactions | … dronedarone, eletriptan, eplerenone, ergotamine, everolimus, felodipine, fentanyl, hormonal contraceptive agents, indinavir, fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam … |
| Fluticasone | drug interactions | … everolimus, felodipine, fentanyl, hormonal contraceptive agents, indinavir, fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, pimozide, quetiapine, quinidine … |
| Lovastatin | drug interactions | … hormonal contraceptive agents, indinavir, fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin … |
| Lurasidone | drug interactions | … contraceptive agents, indinavir, fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus … |
| Maraviroc | drug interactions | … agents, indinavir, fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus … |
| Midazolam | drug interactions | … indinavir, fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan … |
| Nisoldipine | drug interactions | … fluticasone, lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir … |
| Paclitaxel | drug interactions | Metabolized by CYP2C8 Deferasirox inhibits CYP2C8 resulting in an increase in CYP2C8 substrate (e.g., repaglinide and paclitaxel) concentration when these drugs are coadministered. |
| Phenobarbital | drug interactions | The concomitant use of Exjade with potent UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir) may result in a decrease in Exjade efficacy due to a possible decrease in deferasirox … |
| Phenytoin | drug interactions | The concomitant use of Exjade with potent UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir) may result in a decrease in Exjade efficacy due to a possible decrease in deferasirox … |
| Pimozide | drug interactions | … lopinavir, lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam … |
| Quetiapine | drug interactions | … lovastatin, lurasidone, maraviroc, midazolam, nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor … |
| Quinidine | drug interactions | … lurasidone, maraviroc, midazolam, nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, and … |
| Ramelteon | drug interactions | Metabolized by CYP1A2 Deferasirox inhibits CYP1A2 resulting in an increase in CYP1A2 substrate (e.g., alosetron, caffeine, duloxetine, melatonin, ramelteon, tacrine, theophylline, tizanidine) … |
| Repaglinide | drug interactions | DRUG INTERACTIONS Do not take Exjade with aluminum-containing antacid preparations. ( 7.1 ) Exjade increases the exposure of the CYP2C8 substrate repaglinide. |
| Ritonavir | drug interactions | The concomitant use of Exjade with potent UGT inducers (e.g., rifampicin, phenytoin, phenobarbital, ritonavir) may result in a decrease in Exjade efficacy due to a possible decrease in deferasirox … |
| Sildenafil | drug interactions | … midazolam, nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, and vardenafil) [see Clinical … |
| Simvastatin | drug interactions | … nisoldipine, pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, and vardenafil) [see Clinical Pharmacology … |
| Sirolimus | drug interactions | … pimozide, quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, and vardenafil) [see Clinical Pharmacology (12.3)]. |
| Tacrolimus | drug interactions | … quetiapine, quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, and vardenafil) [see Clinical Pharmacology (12.3)]. |
| Theophylline | drug interactions | Consider repaglinide dose reduction and monitor blood glucose levels. ( 7.3 ) Avoid the use of Exjade with CYP1A2 substrate theophylline. ( 7.4 ) Deferasirox increases exposure of busulfan. |
| Ticagrelor | drug interactions | … simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, and vardenafil) [see Clinical Pharmacology (12.3)]. |
| Tizanidine | drug interactions | … caffeine, duloxetine, melatonin, ramelteon, tacrine, theophylline, tizanidine) concentration when these drugs are coadministered. |
| Tolvaptan | drug interactions | … quinidine, saquinavir, sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, and vardenafil) [see Clinical Pharmacology (12.3)]. |
| Triazolam | drug interactions | … sildenafil, simvastatin, sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, and vardenafil) [see Clinical Pharmacology (12.3)]. |
| Vardenafil | drug interactions | … sirolimus, tacrolimus, tolvaptan, tipranavir, triazolam, ticagrelor, and vardenafil) [see Clinical Pharmacology (12.3)]. |
Other labels that name deferasirox
Source: FDA drug label (Exjade), 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 for deferasirox?
The FDA Adverse Event Reporting System holds 26,369 reports that list deferasirox among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other iron chelators
- the pharmacologic class, with prices and generics
- Deferasirox side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other