Imatinib: uses, dosing, side effects & brands

Imatinib is a kinase inhibitor sold in the U.S. under 2 brand and generic names, for lymphoid leukemia, myeloid leukemia and hypereosinophilic syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Kinase Inhibitor
Treats (across its forms): Lymphoid Leukemia, Myeloid Leukemia and Hypereosinophilic Syndrome
Available as: Tablet · Solution
Sold as: 2 products — Gleevec and Imkeldi
Prescription?: Prescription only
Generic available?: Not in our catalog
What the pharmacy pays: about $26 for a 30-count supply — not your price

How Gleevec is dosed

From the FDA label for Gleevec (application NDA021588). Other imatinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Adults with Ph+ CML CP ( 2.2 ): 400 mg/day Adults with Ph+ CML AP or BC ( 2.2 ): 600 mg/day Pediatrics with Ph+ CML CP ( 2.3 ): 340 mg/m 2 /day Adults with Ph+ ALL ( 2.4 ): 600 mg/day Pediatrics with Ph+ ALL ( 2.5 ): 340 mg/m 2 /day Adults with MDS/MPD ( 2.6 ): 400 mg/day Adults with ASM ( 2.7 ): 100 mg/day or 400 mg/day Adults with HES/CEL ( 2.8 ): 100 mg/day or 400 mg/day Adults with DFSP ( 2.9 ): 800 mg/day Adults with metastatic and/or unresectable GIST ( 2.10 ): 400 mg/day Adjuvant treatment of adults with GIST ( 2.11 ): 400 mg/day Patients with mild to moderate hepatic impairment ( 2.12 ): 400 mg/day Patients with severe hepatic impairment ( 2.12 ): 300 mg/day All doses of Gleevec should be taken with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day. Gleevec can be dissolved in water or apple juice for patients having difficulty swallowing. Daily dosing of 800 mg and above should be accomplished using the 400-mg tablet to reduce exposure to iron. 2.1 Drug Administration The prescribed dose should be administered orally, with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a dose of 800 mg should be administered as 400 mg twice a day. For patients unable to swallow the film-coated tablets, the tablets…

Everything below is the FDA label for Gleevec (tablet). Imatinib is also sold as solution, and those are different medicines to take — follow the label for the one you were prescribed.

Gleevec side effects

The following serious adverse reactions are described elsewhere in the labeling: Fluid Retention and Edema [see Warnings and Precautions (5.1)] Hematologic Toxicity [see Warnings and Precautions (5.2)] Congestive Heart Failure and Left Ventricular Dysfunction [see Warnings and Precautions (5.3)] Hepatotoxicity [see Warnings and Precautions (5.4)] Hemorrhage [see Warnings and Precautions (5.5)] Gastrointestinal Disorders [see Warnings and Precautions (5.6)] Hypereosinophilic Cardiac Toxicity [see Warnings and Precautions (5.7)] Dermatologic Toxicities [see Warnings and Precautions (5.8)] Hypothyroidism [see Warnings and Precautions (5.9)] Growth Retardation in Children and Adolescents [see Warnings and Precautions (5.11)] Tumor Lysis Syndrome [see Warnings and Precautions (5.12)] Impairments Related to Driving and Using Machinery [see Warnings and Precautions (5.13)] Renal Toxicity [see Warnings and Precautions (5.14)] The most frequently reported adverse reactions (greater than or equal to 30%) are edema, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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…

Who shouldn’t take Gleevec

None. None. ( 4 )

Gleevec drug interactions

CYP3A4 inducers may decrease Gleevec C max and area under curve (AUC). ( 2.12 , 7.1 , 12.3 ) CYP3A4 inhibitors may increase Gleevec C max and AUC. ( 7.2 , 12.3 ) Gleevec is an inhibitor of CYP3A4 and CYP2D6 which may increase the C max and AUC of other drugs. ( 7.3 , 7.4 , 12.3 ) Patients who require anticoagulation should receive low-molecular weight or standard heparin and not warfarin. ( 7.3 ) Gleevec may delay the clearance of methotrexate when methotrexate is used at high doses (> 500 mg/m 2 ). ( 7.5 ) 7.1 Agents Inducing CYP3A Metabolism Concomitant administration of Gleevec and strong CYP3A4 inducers may reduce total exposure of imatinib; consider alternative agents [see Clinical Pharmacology (12.3)]. 7.2 Agents Inhibiting CYP3A Metabolism Concomitant administration of Gleevec and strong CYP3A4 inhibitors may result in a significant imatinib exposure increase. Grapefruit juice may also increase plasma concentrations of imatinib; avoid grapefruit juice [see Clinical Pharmacology (12.3)] . 7.3 Interactions With Drugs Metabolized by CYP3A4 Gleevec will increase plasma concentration of CYP3A4 metabolized drugs (e.g., triazolo-benzodiazepines, dihydropyridine calcium channel blockers, certain HMG-CoA reductase inhibitors, etc.). Use caution when administering Gleevec with CYP3A4 substrates that have a narrow therapeutic window. Because warfarin is metabolized by CYP2C9 and CYP3A4, use low-molecular weight or standard heparin instead of warfarin in patients who require anticoagulation [see Clinical Pharmacology (12.3)] . 7.4 Interactions With Drugs Metabolized by CYP2D6 Use caution when administering Gleevec with CYP2D6 substrates that have a narrow therapeutic window. 7.5 Interactions With Methotrexate Gleevec may delay the clearance of methotrexate and result in sustained methotrexate concentrations when methotrexate is used at high doses (> 500 mg/m 2 ). Refer to the prescribing information for methotrexate injection for recommendations on management of methotrexate concentrations.

Every imatinib product we track (2)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Imatinib products
#	Drug	Rating	Type	Form	Generic?	Pharmacy pays
1	Gleevec	70/100	Prescription	Tablet	Generic	$26	View →
2	Imkeldi	Not yet rated	Prescription	Solution	Generic	$26	View →

What imatinib pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Imatinib pill imprints
Imprint	Strength	Colour	Shape	Maker
472	100 mg	yellow	round	—
475	400 mg	yellow	oval	—
100	100 mg	yellow	round	—
400	400 mg	yellow	oval	—
M;I;100	100 mg	brown	round	—
MYLAN;I;400	400 mg	brown	oval	—
TE;VA;7630	400 mg	orange	oval	—
M;I;100	100 mg	brown	round	—
MYLAN;I;400	400 mg	brown	oval	—
TE;VA;7629	100 mg	orange	round	—

Can you crush or split imatinib?

At least one imatinibproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.

What each imatinib label says about crushing, splitting and chewing

How long imatinib keeps

No imatinib label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does imatinib expire? The in-use limits and storage rules from its labels

Imatinib and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Limited information indicates that maternal doses of imatinib up to 400 mg daily produce low levels of the drug and its active metabolite in milk. Although a few breastfed infants apparently experienced no adverse effects during maternal use of imatinib, no long-term data are available. Until more data are available, imatinib should be used only with careful monitoring during breastfeeding. National Comprehensive Cancer Network guidelines, the manufacturer and some authors recommend that breastfeeding be discontinued during imatinib therapy and for 1 month after therapy.

Full LactMed record for imatinib: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised October 15, 2024. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about imatinib

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 4,167 reports naming imatinib, and the FDA flagged 79% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

nausea320 reports
diarrhoea278 reports
fatigue213 reports
vomiting192 reports
dyspnoea159 reports
abdominal pain145 reports
neoplasm malignant142 reports
pyrexia139 reports

Read these as a signal, not a rate. A report does not mean imatinib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved August 25, 2026.

Related calculators

How long it stays in your system →

Frequently asked questions

What is Gleevec?

Imatinib is a small molecule kinase inhibitor. Gleevec film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib free base. Each 400 mg tablet contains 478 mg of imatinib mesylate equivalent to 400 mg of imatinib free base.

What kind of drug is imatinib?

The FDA classifies imatinib as a kinase inhibitor. Kinase inhibitors block protein kinases, the enzymes that relay 'grow and divide' signals inside cells. By shutting down the overactive kinase signals that a tumor depends on, they help slow or stop cancer cells from multiplying. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Can you take imatinib with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run imatinib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is imatinib sold under?

We track 2 imatinib-containing products in the U.S.: Gleevec and Imkeldi. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does imatinib come in?

Across the brands we track, imatinib is currently marketed as tablet and solution, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic imatinib?

We do not currently list a generic-labelled imatinib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page

APA: pharmaranks. (2026, July 24). Imatinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/imatinib
MLA: “Imatinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/imatinib.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for imatinib on DailyMed (NIH) ↗.