What the label lists and what reports show
Vimseltinib side effects
Vimseltinib's FDA label: “Most common adverse reactions (incidence ≥20%), including laboratory abnormalities are increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased …” FAERS holds 532 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (133 reports).
- No generic listed
Check it at the source: the vimseltinib FDA label on DailyMed (effective June 26, 2026, Deciphera Pharmaceuticals, LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ROMVIMZA?ROMVIMZA can cause serious side effects. See “ What is the most important information I should know about ROMVIMZA? ” Allergic reactions to FD&C Yellow No. 5 and FD&C Yellow No. 6 . ROMVIMZA 20 mg capsules contain the inactive ingredients FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6 (Sunset Yellow FCF). ROMVIMZA 14 mg capsules contain the inactive ingredient FD&C Yellow No. 6 (Sunset Yellow FCF). FD&C Yellow No. 5 (tartrazine) can cause allergic-type reactions (including bronchial asthma) in certain people, especially people who also have an allergy to aspirin. FD&C Yellow No. 6 (Sunset Yellow FCF) can also cause allergic reactions. Tell your healthcare provider if you get hives, rash, or trouble breathing during treatment with ROMVIMZA. […]
Source: FDA drug label, Deciphera Pharmaceuticals, LLC, effective June 26, 2026 (SPL set f73c7a62-9601-4df0-810f-100f515d79ea), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥20%), including laboratory abnormalities are increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT.
Table 3: Adverse Reactions Occurring in ≥10% of Patients Receiving ROMVIMZA with a Difference Between Arms of >5% Compared to Placebo Through Week 25 in MOTION
| Reaction | All Grades (%) | Grade 3 or 4 (%) | All Grades (%) | Grade 3 or 4 (%) |
|---|---|---|---|---|
| Periorbital edema 1 | 60 | 3.6 | 21 | 0 |
| Lacrimation increased | 12 | 0 | 0 | 0 |
| Dry eye 1 | 10 | 0 | 0 | 0 |
| Fatigue 1 | 59 | 1.2 | 38 | 2.6 |
| Peripheral edema 1 | 33 | 1.2 | 8 | 0 |
| Face edema | 31 | 1.2 | 8 | 0 |
| Rash 1 | 47 | 3.6 | 5 | 0 |
| Pruritus | 29 | 2.4 | 8 | 0 |
| Hypertension | 17 | 4.8 | 10 | 2.6 |
| Neuropathy 1 | 12 | 1.2 | 2.6 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Hepatotoxicity [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (incidence ≥20%), including laboratory abnormalities are increased AST, periorbital edema, fatigue, rash, increased cholesterol, peripheral edema, face edema, decreased neutrophils, decreased leukocytes, pruritus, and increased ALT. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Deciphera Pharmaceuticals, LLC at 1-888-724-3274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the Warnings and Precautions reflects exposure to ROMVIMZA in 83 patients with TGCT enrolled in the double-blind portion and in 35 patients with TGCT in the open-label portion who crossed over to ROMVIMZA in MOTION, and in 135 patients with TGCT or solid tumors in other clinical trials. The safety of ROMVIMZA was evaluated in 83 adult patients with TGCT in MOTION [see Clinical Studies ( 14 )]. MOTION excluded patients with bilirubin, AST, or ALT >ULN. …
Source: FDA drug label, Deciphera Pharmaceuticals, LLC, effective June 26, 2026 (SPL set f73c7a62-9601-4df0-810f-100f515d79ea), via openFDA; the full label on DailyMed
What do FAERS reports show?
532 reports list vimseltinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 19 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. Of the 23 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Vimseltinib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions