Prescription medicine
Eltrombopag Brand names: Promacta, Alvaiz
Eltrombopag (Promacta) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 13 generic labelers, and pharmacies paid $25.85 per eltrombopag 50 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the eltrombopag FDA label on DailyMed (effective December 18, 2025, Novartis Pharmaceuticals Corporation); the NDA 22291 record on Drugs@FDA; every eltrombopag label on DailyMed.
Highlights of the record
FDA label of December 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C.
and RISK OF HEPATOTOXICITY In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions (5.1)]. PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended [see Warnings and Precautions (5.2)]. WARNING: RISK FOR HEPATIC DECOMPENSATION IN PATIENTS WITH CHRONIC HEPATITIS C and RISK OF HEPATOTOXICITY See full prescribing information for complete boxed warning. In patients with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation. ( 5.1 ) PROMACTA may increase the risk of severe and potentially life-threatening hepatotoxicity. Monitor hepatic function and discontinue dosing as recommended.
Used for
From the label: indications and usagePROMACTA is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Forms and strengths
- 9 mg
- 12.5 mg
- 18 mg
- 25 mg
- 36 mg
- 50 mg
- 54 mg
- 75 mg
Film-coated tablet; tablet; powder for suspension.
On the market
- Earliest approval on file
- November 20, 2008 Promacta, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first April 18, 2024; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 13 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- January 13, 2026 Promacta tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $25.85 per tablet Eltrombopag 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2019 1 Class I among all firms' recalls; latest May 11, 2019
- FAERS reports
- 22,949 through July 30, 2026
What is eltrombopag used for?
From the label: indications and usagePROMACTA is a thrombopoietin receptor agonist indicated: for the treatment of thrombocytopenia in adult and pediatric patients 1 year and older with persistent or chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. PROMACTA should be used only in patients with ITP whose degree of thrombocytopenia and clinical condition increase the risk for bleeding. ( 1.1 ) for the treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy. […]
Conditions named in the indications of eltrombopag's FDA labels, with every medicine labeled for each:
From other eltrombopag labelsAnemia: Treatment of Severe Aplastic Anemia PROMACTA is indicated in combination with standard immunosuppressive therapy (IST) for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia.
FDA pharmacologic class: Thrombopoietin Receptor Agonist.
Source: FDA drug label (PROMACTA), Novartis Pharmaceuticals Corporation, effective December 18, 2025 (SPL set 7714a0ed-34bb-46e6-a0a5-b363908b22c2), via openFDA; the full label on DailyMed
What does the patient leaflet for eltrombopag 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 PROMACTA?PROMACTA can cause serious side effects, including: Liver problems: If you have chronic hepatitis C virus and take PROMACTA with interferon and ribavirin treatment, PROMACTA may increase your risk of liver problems. If your healthcare provider tells you to stop your treatment with interferon and ribavirin, you will also need to stop taking PROMACTA. PROMACTA may increase your risk of liver problems that may be severe and possibly life threatening. Your healthcare provider will do blood tests to check your liver function before you start taking PROMACTA and during your treatment. Your healthcare provider may stop your treatment with PROMACTA if you have changes in your liver function blood tests. Tell your healthcare provider right away if you have any of these signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice) unusual darkening of the urine unusual tiredness right upper stomach area (abdomen) pain confusion swelling of the stomach area (abdomen) See “What are the possible side effects of PROMACTA?” for other side effects of PROMACTA.
From the patient leaflet: What should I avoid while taking PROMACTA?Avoid situations and medicines that may increase your risk of bleeding.
From the patient leaflet: How should I store PROMACTA tablets and PROMACTA for oral suspension?Tablets: Store PROMACTA tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep PROMACTA in the bottle given to you. For oral suspension: Store PROMACTA for oral suspension at room temperature between 68°F to 77°F (20°C to 25°C). After mixing, PROMACTA should be taken right away but may be stored for no more than 30 minutes between 68°F to 77°F (20°C to 25°C). Throw away (discard) the mixture if not used within 30 minutes. Keep PROMACTA and all medicines out of the reach of children.
Source: FDA drug label (PROMACTA), Novartis Pharmaceuticals Corporation, effective December 18, 2025 (SPL set 7714a0ed-34bb-46e6-a0a5-b363908b22c2), via openFDA; the full label on DailyMed
Is there a generic for eltrombopag (Promacta)?
The FDA approved the first generic eltrombopag on April 18, 2024. 11 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists eltrombopag from 13 labelers under a generic (ANDA) application and from 2 brand labelers. 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 Promacta tablets: the compound patent runs to July 13, 2025 (pediatric exclusivity to January 13, 2026); a patent listed only for Alvaiz tablets runs to November 5, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2008 earliest approval on file
- 2024 first generic approved
- 2026 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 eltrombopag (Promacta)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $25.85 per Eltrombopag 50 mg tablet. 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.
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Eltrombopag 50 mg tablet | Generic | $25.85 per tablet | $775.47 | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has eltrombopag been recalled?
The FDA's Enforcement Report lists 1 recall naming eltrombopag since 2019: 1 Class I (the most serious), 0 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 11, 2019 | Class I | Novartis Pharmaceuticals Corp. | Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the eltrombopag label say about other medicines?
The eltrombopag label names 23 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name eltrombopag. 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 |
|---|---|---|
| Atorvastatin | drug interactions | Use caution when concomitantly administering PROMACTA and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast … |
| Azacitidine | warnings and precautions | … Prognostic Scoring System (IPSS) intermediate-1, intermediate-2 or high risk MDS with thrombocytopenia, receiving azacitidine in combination with either PROMACTA (n = 179) or placebo (n = 177) was terminated due to lack of efficacy and safety reasons, including increased progression to acute myeloid leukemia (AML). |
| Bosentan | drug interactions | Use caution when concomitantly administering PROMACTA and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast … |
| Ezetimibe | drug interactions | Use caution when concomitantly administering PROMACTA and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast … |
| Fluvastatin | drug interactions | Use caution when concomitantly administering PROMACTA and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast … |
| Glyburide | drug interactions | Use caution when concomitantly administering PROMACTA and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast … |
| Imatinib | drug interactions | … acid, SN-38 [active metabolite of irinotecan], valsartan) or breast cancer resistance protein (BCRP) (e.g., imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, topotecan). |
| Irinotecan | drug interactions | … pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast cancer resistance protein (BCRP) (e.g., imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, topotecan). |
| Lopinavir and ritonavir | drug interactions | Protease Inhibitors HIV Protease Inhibitors: No dose adjustment is recommended when PROMACTA is coadministered with lopinavir/ritonavir (LPV/RTV). |
| Methotrexate | drug interactions | … irinotecan], valsartan) or breast cancer resistance protein (BCRP) (e.g., imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, topotecan). |
| Mitoxantrone | drug interactions | … valsartan) or breast cancer resistance protein (BCRP) (e.g., imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, topotecan). |
| Olmesartan | drug interactions | Use caution when concomitantly administering PROMACTA and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast … |
| Peginterferon alfa 2a | drug interactions | No dose adjustments are recommended when PROMACTA is coadministered with peginterferon alfa-2a (PEGASYS ® ) or -2b (PEGINTRON ® ). |
| Pitavastatin | drug interactions | Use caution when concomitantly administering PROMACTA and drugs that are substrates of OATP1B1 (e.g., atorvastatin, bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast … |
Every other medicine the eltrombopag label names
| Medicine named | Section | What the label says |
|---|---|---|
| Pravastatin | drug interactions | … bosentan, ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or … |
| Repaglinide | drug interactions | … fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast cancer resistance … |
| Ribavirin | boxed warning | … with chronic hepatitis C, PROMACTA in combination with interferon and ribavirin may increase the risk of hepatic decompensation [see Warnings and Precautions (5.1)]. |
| Rifampin | drug interactions | … olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast cancer resistance protein (BCRP) (e.g. … |
| Rosuvastatin | drug interactions | … ezetimibe, fluvastatin, glyburide, olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast cancer … |
| Simvastatin | drug interactions | … olmesartan, pitavastatin, pravastatin, rosuvastatin, repaglinide, rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast cancer resistance protein (BCRP) (e.g. … |
| Sulfasalazine | drug interactions | … imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, topotecan). |
| Topotecan | drug interactions | … lapatinib, methotrexate, mitoxantrone, rosuvastatin, sulfasalazine, topotecan). |
| Valsartan | drug interactions | … rifampin, simvastatin acid, SN-38 [active metabolite of irinotecan], valsartan) or breast cancer resistance protein (BCRP) (e.g., imatinib, irinotecan, lapatinib, methotrexate, mitoxantrone … |
Other labels that name eltrombopag
Source: FDA drug label (PROMACTA), Novartis Pharmaceuticals Corporation, effective December 18, 2025 (SPL set 7714a0ed-34bb-46e6-a0a5-b363908b22c2), via openFDA; the full label on DailyMed
What do FAERS reports show for eltrombopag?
The FDA Adverse Event Reporting System holds 22,949 reports that list eltrombopag among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 4,880 are coded as a death and 5,578 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 else is labeled for the same conditions as eltrombopag?
6 other medicines are given the same way (oral) and in the same FDA class as eltrombopag or labeled mainly for the same use (anemia), the same class first. Anemia lists all 25 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Prednisolone | Anemia | 23 labelers | $0.568 per mL 15 mg/5 mL solution | No current entry |
| Daprodustat | Anemia | none listed | n/a | No current entry |
| Mitapivat | Anemia | none listed | n/a | No current entry |
| Vadadustat | Anemia | none listed | n/a | No current entry |
| Tetraferric tricitrate decahydrate | Anemia | none listed | $6.28 per tablet 210 mg tablet | No current entry |
| Ferric citrate | Anemia | 1 labeler | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other thrombopoietin receptor agonists
- the pharmacologic class, with prices and generics
- Eltrombopag side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other