Prescription medicine
Fostamatinib Brand names: Tavalisse
Fostamatinib (Tavalisse) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the fostamatinib FDA label on DailyMed (effective November 5, 2025, Rigel Pharmaceuticals, Inc.); the NDA 209299 record on Drugs@FDA; every fostamatinib label on DailyMed.
Highlights of the record
FDA label of November 5, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Forms and strengths
- 100 mg
- 150 mg
Tablet.
On the market
- Earliest approval on file
- April 17, 2018 Tavalisse, Rigel Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first June 17, 2026; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- July 27, 2032 Tavalisse tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 7,695 through July 30, 2026
What is fostamatinib used for?
From the label: indications and usageTAVALISSE is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment. TAVALISSE is a kinase inhibitor indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.
Source: FDA drug label (TAVALISSE), Rigel Pharmaceuticals, Inc., effective November 5, 2025 (SPL set 21149cc3-049b-43e2-b141-c9499160556c), via openFDA; the full label on DailyMed
What does the patient leaflet for fostamatinib 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 TAVALISSE?TAVALISSE can cause serious side effects, including: High blood pressure (hypertension). New or worsening high blood pressure is common in people treated with TAVALISSE and can be severe. Your healthcare provider will check your blood pressure regularly during treatment with TAVALISSE. If needed, your healthcare provider may start you on blood pressure medicine or change your current medicine to treat your blood pressure. Tell your healthcare provider if you get headaches, confusion, dizziness, chest pain or shortness of breath. Liver problems. Changes in liver function blood tests are common with TAVALISSE. Liver problems may occur and can be severe. Your healthcare provider will regularly do blood tests to check how well your liver is working during treatment with TAVALISSE. Diarrhea. Diarrhea is common in people treated with TAVALISSE and can be severe. Tell your healthcare provider if you get diarrhea during treatment with TAVALISSE. Your healthcare provider may recommend changes in your diet, drinking more water, or medicine to limit these symptoms. Decrease in white blood cell counts (neutropenia). Decreases in your white blood cell count are common with TAVALISSE and can be severe. This may increase your risk for infection, including serious infections. Your healthcare provider will regularly do blood tests to check your white blood cell counts. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TAVALISSE if you have side effects. See " What are the possible side effects of TAVALISSE? " for more information about side effects.
From the patient leaflet: How should I store TAVALISSE?Store TAVALISSE at room temperature between 68°F and 77°F (20°C to 25°C). The bottle of TAVALISSE contains 2 desiccant canisters that help keep your medicine dry. Do not remove the desiccant canisters from the bottle. Keep TAVALISSE and all medicines out of the reach of children.
Source: FDA drug label (TAVALISSE), Rigel Pharmaceuticals, Inc., effective November 5, 2025 (SPL set 21149cc3-049b-43e2-b141-c9499160556c), via openFDA; the full label on DailyMed
Is there a generic for fostamatinib (Tavalisse)?
The FDA approved the first generic fostamatinib on June 17, 2026. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 14 patents for Tavalisse tablets: the compound patent runs to September 4, 2031, and the last listed entry to July 27, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2026 first generic approved
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the fostamatinib label say about other medicines?
The fostamatinib label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 5 other medicines name fostamatinib. 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 |
|---|---|---|
| Digoxin | drug interactions | P-Glycoprotein (P-gp) Substrates Concomitant use of TAVALISSE may increase concentrations of P-gp substrates (e.g., digoxin). |
| Rosuvastatin | drug interactions | BCRP Substrates Concomitant use of TAVALISSE may increase concentrations of BCRP substrate drugs (e.g., rosuvastatin). |
Other labels that name fostamatinib
Source: FDA drug label (TAVALISSE), Rigel Pharmaceuticals, Inc., effective November 5, 2025 (SPL set 21149cc3-049b-43e2-b141-c9499160556c), via openFDA; the full label on DailyMed
What do FAERS reports show for fostamatinib?
The FDA Adverse Event Reporting System holds 7,695 reports that list fostamatinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 463 are coded as a death and 1,695 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?
- Fostamatinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other