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Selumetinib

Selumetinib is a targeted prescription medicine (a kinase inhibitor) used to treat neurofibromatosis type 1 (NF1) in adults and children 1 year and older who have symptomatic plexiform neurofibromas that cannot be surgically removed.

Brand name Koselugo
Drug class Kinase Inhibitor
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Selumetinib at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Selumetinib (Koselugo), a specialist drug, blocks two growth-signal proteins, MEK1 and MEK2, to treat plexiform neurofibromas (nerve tumors) that cause symptoms and cannot be removed surgically in people 1 year and older with neurofibromatosis type 1 (NF1); on the U.S. market since about 2020, it was the first medicine approved for them. Most people manage it with support, though vomiting, diarrhea, an acne-like rash and sore, infected skin around the nails are common. Expect heart scans (echocardiograms), eye exams and blood tests throughout, and report blurred vision, breathlessness, swelling, worsening diarrhea, rash or muscle pain promptly. It can also harm an unborn baby.

Clinical pearls

  • Swallow capsules whole; the oral granules must never be mixed with grapefruit, any juice, or Seville orange jam or puree.
  • Capsules contain vitamin E, so avoid extra vitamin E supplements and mention warfarin or antiplatelet medicines, which can raise bleeding risk.
  • Fluconazole and other drugs that block CYP3A4 (a liver enzyme) can raise levels, so every new prescription needs an interaction check.
  • Use effective birth control during treatment and for 1 week after the last dose, including men with female partners.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asCapsule, Oral powder
Earliest FDA record2020
Companies listing it with the FDA1
FDA label last updatedMay 26, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Selumetinib, written from its FDA label.

What Selumetinib is used for

▾

Selumetinib is used for one condition, across its supported forms.

  • Neurofibromatosis type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas, in adults and children 1 year and older (Koselugo capsules and Koselugo oral granules).

How Selumetinib works

▾

Selumetinib blocks MEK1 and MEK2, proteins that pass growth signals along the RAF-MEK-ERK pathway. This pathway is often overactive in tumors. By blocking it, selumetinib reduced the number, size and growth of neurofibromas in mouse models of NF1.

Selumetinib dosage

▾

Koselugo is taken by mouth twice a day, with the dose based on body size. Your prescriber sets the exact amount.

  • Capsules: swallow whole, with or without food.
  • Oral granules: for people who can't swallow capsules. Mix with a small amount of soft food and eat within 30 minutes.
  • Missed dose: make it up unless your next dose is due within 6 hours.
  • Vomiting: do not take an extra dose. Take the next one at the usual time.

Dosing details from the FDA-approved label

From the Selumetinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adult and pediatric patients 1 year of age and older - KOSELUGO capsules (BSA 0.55 m2 or greater)
    • 25 mg/m2 orally twice daily, swallowed whole, with or without food, until disease progression or unacceptable toxicity
    • By BSA: 0.55 – 0.69 m2: 20 mg in the morning and 10 mg in the evening
    • 0.70 – 0.89 m2: 20 mg twice daily
    • 0.90 – 1.09 m2: 25 mg twice daily
    • 1.10 – 1.29 m2: 30 mg twice daily
    • 1.30 – 1.49 m2: 35 mg twice daily
    • 1.50 – 1.69 m2: 40 mg twice d
    • Dosage for BSA less than 0.55 m2 has not been established; do not open, chew or crush capsules
  • Adult and pediatric patients 1 year of age and older - KOSELUGO oral granules (BSA 0.40 m2 or greater)
    • Equivalent to 25 mg/m2 orally twice daily, sprinkled onto or mixed with soft food, until disease progression or unacceptable toxicity
    • By BSA: 0.40 – 0.59 m2: 12.5 mg twice daily
    • 0.60 – 0.69 m2: 15 mg twice daily
    • 0.70 – 0.89 m2: 20 mg twice daily
    • 0.90 – 1.09 m2: 25 mg twice daily
    • 1.10 – 1.29 m2: 30 mg twice daily
    • 1.30 – 1.49 m2: 35 mg twice daily
    • 1.50
    • Dosage for BSA less than 0.40 m2 has not been established; for patients who have difficulty swallowing whole capsules; consume within 30 minutes of preparation
  • Moderate hepatic impairment (Child-Pugh B), pediatric patients 1 year of age or older - capsules
    • 20 mg/m2 orally twice daily, until disease progression or unacceptable toxicity
    • Morning/evening mg by BSA: 0.55 – 0.69 m2: 10/10
    • 0.70 – 0.89 m2: 20/10
    • 0.90 – 1.09 m2: 20/20
    • 1.10 – 1.29 m2: 25/25
    • 1.30 – 1.49 m2: 30/25
    • 1.50 – 1.69 m2: 35/30
    • 1.70 – 1.89 m2: 35/35
    • ≥ 1.90 m2: 40/40
    • Based on body surface area
  • Moderate hepatic impairment (Child-Pugh B), pediatric patients 1 year of age or older - oral granules
    • 20 mg/m2 orally twice daily, until disease progression or unacceptable toxicity
    • Morning/evening mg by BSA: 0.40 – 0.59 m2: 10/10
    • 0.60 – 0.69 m2: 12.5/12.5
    • 0.70 – 0.89 m2: 15/15
    • 0.90 – 1.09 m2: 20/20
    • 1.10 – 1.29 m2: 25/25
    • 1.30 – 1.49 m2: 30/25
    • 1.50 – 1.69 m2: 35/30
    • 1.70 – 1.89 m2: 35/35
    • ≥ 1.90 m2: 40/40
    • Based on body surface area
  • Severe hepatic impairment (Child-Pugh C)
    • The recommended dosage has not been established
  • Coadministration with strong or moderate CYP3A4 inhibitors or fluconazole (if it cannot be avoided)
    • If the current dosage is 25 mg/m2 twice daily, reduce to 20 mg/m2 twice daily
    • If the current dosage is 20 mg/m2 twice daily, reduce to 15 mg/m2 twice daily (see Tables 8 and 9)
    • After discontinuing the inhibitor or fluconazole for 3 elimination half-lives, resume the dose taken before starting it
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION • KOSELUGO capsules: The recommended dosage is 25 mg/m 2 , swallowed whole, taken orally twice daily with or without food (see Table 1) . (2.1 , 2.2 ) • KOSELUGO oral granules: The recommended dosage is equivalent to 25 mg/m 2 , sprinkled onto or mixed with soft food and taken orally twice daily (see Table 2). ( 2.1 , 2.2 ) • Moderate hepatic impairment (Child-Pugh B): The recommended dosage is 20 mg/m 2 orally twice daily (see Tables 6 and 7) . ( 2.2 , 2.4 ) • Severe hepatic impairment (Child-Pugh C): The recommended dosage has not been established. ( 2.4 , 8.6 ) • Strong or Moderate CYP3A4 Inhibitors or Fluconazole: If coadministration with strong or moderate CYP3A4 inhibitors or fluconazole cannot be avoided, reduce the dose of KOSELUGO (see Tables 8 and 9) . ( 2.5 ) 2.1 Recommended Dosage The recommended dosage of KOSELUGO capsules ( see Table 1 ) and KOSELUGO oral granules ( see Table 2 ) for adult and pediatric patients 1 year of age and older, based on body surface area, is 25 mg/m 2 orally twice daily, until disease progression or unacceptable toxicity [see Dosage and Administration (2.2)]. Table 1 Recommended Dosage: KOSELUGO Capsules Body Surface Area The recommended dosage of KOSELUGO capsules for patients with a BSA less than 0.55 m 2 has not been established. KOSELUGO Capsules 0.55 – 0.69 m 2 20 mg in the morning and 10 mg in the evening 0.70 – 0.89 m 2 20 mg twice daily 0.90 – 1.09 m 2 25 mg twice daily 1.10 – 1.29 m 2 30 mg twice daily 1.30 – 1.49 m 2 35 mg twice daily 1.50 – 1.69 m 2 40 mg twice daily 1.70 – 1.89 m 2 45 mg twice daily ≥ 1.90 m 2 50 mg twice daily Table 2 Recommended Dosage: KOSELUGO Oral Granules Body Surface Area The recommended dosage of KOSELUGO oral granules for patients with a BSA less than 0.40 m 2 has not been established. KOSELUGO Oral Granules 0.40 – 0.59 m 2 12.5 mg twice daily 0.60 – 0.69 m 2 15 mg twice daily 0.70 – 0.89 m 2 20 mg twice daily 0.90 – 1.09 m 2 25 mg twice daily 1.10 – 1.29 m 2 30 mg twice daily 1.30 – 1.49 m 2 35 mg twice daily 1.50 – 1.69 m 2 40 mg twice daily 1.70 – 1.89 m 2 45 mg twice daily ≥ 1.90 m 2 50 mg twice daily 2.2 Administration KOSELUGO is available in two dosage forms: KOSELUGO capsules and KOSELUGO oral granules. Prescribe KOSELUGO oral granules for patients who have difficulty swallowing whole capsules.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Selumetinib side effects

▾

Common side effects seen in studies include:

Common side effects

  • Vomiting
  • Nausea
  • Diarrhea
  • Rash, including acne-like rash
  • Dry skin
  • Infection around the nails (paronychia)
  • Fever
  • Raised creatine phosphokinase (a muscle enzyme found on blood tests)
  • Stomach pain, tiredness and headache in some patients

When to get medical help

  • Call your doctor if you have new or worsening vision changes, such as blurred vision.
  • Call your doctor if you have shortness of breath, swelling, or a fast or pounding heartbeat, which can be signs of reduced heart pumping function.
  • Call your doctor if you have loose stools. Start an anti-diarrheal and drink more fluids as directed, and ask your prescriber what to do.
  • Call your doctor if you get a severe rash or skin problems.
  • Call your doctor if you have muscle pain, tenderness or weakness. Muscle breakdown (rhabdomyolysis) can occur.
  • Tell your doctor about any unusual bleeding, especially if you take a blood thinner or antiplatelet medicine and use the capsules.
  • Tell your doctor right away if you become pregnant or think you may be.

Selumetinib warnings and precautions

▾
  • Heart function: selumetinib can lower ejection fraction (how well the heart pumps). Echocardiograms are done before and during treatment.
  • Eyes: it can cause blurred vision, retinal vein occlusion and retinal pigment epithelial detachment. Eye exams are done regularly.
  • Diarrhea and colitis: start an anti-diarrheal at the first loose stool and drink more fluids.
  • Skin: severe rashes can occur.
  • Muscles: raised creatine phosphokinase and rhabdomyolysis can occur. Blood levels are checked.
  • Bleeding (capsules): they contain vitamin E, which may raise bleeding risk with vitamin K antagonists or antiplatelet medicines.
  • Pregnancy: it can cause fetal harm.

Selumetinib interactions

▾

Some medicines change how much selumetinib is in your body.

  • Strong or moderate CYP3A4 inhibitors and fluconazole raise levels and may increase side effects. Avoid them, or your dose will be lowered.
  • Strong or moderate CYP3A4 inducers lower levels and may make it less effective. Avoid them.
  • Vitamin E supplements: the capsules already contain vitamin E, and too much may raise bleeding risk.
  • Vitamin K antagonists and antiplatelet agents with the capsules: bleeding risk may rise, so closer monitoring is needed.
  • Grapefruit, any juice, or Seville orange products should not be mixed with the oral granules.

Interactions listed in the FDA-approved label

From the Selumetinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong or moderate CYP3A4 inhibitors or fluconazole: Concomitant use increased selumetinib plasma concentrations, which may increase the risk of adverse reactions. Avoid coadministration; if it cannot be avoided, reduce the KOSELUGO dosage.
  • Strong or moderate CYP3A4 inducers: Concomitant use decreased selumetinib plasma concentrations, which may reduce KOSELUGO efficacy. Avoid concomitant use.
  • Vitamin E: KOSELUGO capsules contain vitamin E, and daily vitamin E intake exceeding the recommended or safe limits may increase the risk of bleeding. Supplemental vitamin E is not recommended if daily vitamin E intake (including the amount in KOSELUGO capsules and supplement) will exceed the recommended or safe limits.
  • Vitamin-K antagonist or anti-platelet agent (with KOSELUGO capsules): An increased risk of bleeding may occur in patients taking these with KOSELUGO capsules. Monitor for bleeding; increase INR monitoring, as appropriate, in patients taking a vitamin-K antagonist.
Read the label’s full interactions text

7 DRUG INTERACTIONS • Strong or Moderate CYP3A4 Inhibitors or Fluconazole : Avoid coadministration of strong or moderate CYP3A4 inhibitors or fluconazole with KOSELUGO. If coadministration cannot be avoided, reduce the dose of KOSELUGO. ( 2.5 , 7.1 ) • Strong or Moderate CYP3A4 Inducers : Avoid concomitant use of strong and moderate CYP3A4 inducers. ( 7.1 ) 7.1 Effect of Other Drugs on KOSELUGO Strong or Moderate CYP3A4 Inhibitors or Fluconazole Management • Avoid concomitant use of strong or moderate CYP3A4 inhibitors or fluconazole with KOSELUGO. If coadministration with strong or moderate CYP3A4 inhibitors or fluconazole cannot be avoided, reduce KOSELUGO dosage [see Dosage Modifications for Drug Interactions (2.5) ]. Clinical Impact • Concomitant use of KOSELUGO with a strong or moderate CYP3A4 inhibitor or fluconazole increased selumetinib plasma concentrations [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions. Strong or Moderate CYP3A4 Inducers Management • Avoid concomitant use of strong or moderate CYP3A4 inducers with KOSELUGO. Clinical Impact • Concomitant use of KOSELUGO with a strong or moderate CYP3A4 inducer decreased selumetinib plasma concentrations [see Clinical Pharmacology (12.3) ] , which may reduce KOSELUGO efficacy. Vitamin E Management • Supplemental vitamin E is not recommended if daily vitamin E intake (including the amount of vitamin E in KOSELUGO capsules and supplement) will exceed the recommended or safe limits. • Monitor for bleeding in patients administered a vitamin‑K antagonist or an anti‑platelet agent with KOSELUGO capsules. Increase INR monitoring, as appropriate, in patients taking a vitamin‑K antagonist [see Warnings and Precautions (5.3) ] . Clinical Impact • KOSELUGO capsules contain vitamin E and daily vitamin E intake that exceeds the recommended or safe limits may increase the risk of bleeding.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿282 supplements and herbs with documented Selumetinib interactions, ranked by severity Check Selumetinib against a supplement or herb →

Before taking Selumetinib

▾
  • There are no listed contraindications.
  • Pregnancy: it can harm an unborn baby. A pregnancy test is checked before starting.
  • Use effective contraception during treatment and for 1 week after the last dose (applies to males with female partners too).
  • Do not breastfeed during treatment and for 1 week after the last dose.
  • Heart disease or low ejection fraction: it has not been studied in these patients.
  • Moderate liver impairment needs a lower dose. A dose for severe liver impairment is not established.
  • Children under 1 year: safety and effectiveness are not established.
  • Adults 65 and older: not enough people were studied to know if response differs.

Selumetinib overdose

▾

Dialysis is not effective for a Koselugo overdose, because the drug is highly bound to proteins and extensively broken down by the body. If you think too much was taken, contact a doctor or poison control right away.

What Selumetinib does in the body

▾

The relationship between selumetinib levels and its safety and effectiveness has not been fully characterized. At 1.5 times the maximum recommended dose, no clinically significant QTc prolongation (a heart rhythm timing change) was seen.

How your body processes Selumetinib

▾

About 62% of an oral dose is absorbed, and levels peak at a median of about 1.5 hours. Food, even high-fat meals, did not meaningfully change how it is absorbed. Selumetinib is mostly broken down by the liver enzyme CYP3A4, and has an active breakdown product. Its half-life is about 9 hours, and it leaves the body mainly in feces and also in urine. The granules and capsules showed similar exposure in the studies described.

How to store Selumetinib

▾

KOSELUGO Capsules Store KOSELUGO capsules at 20°C to 25°C (68°F to 77°F) with excursions permitted to 15°C to 30°C (59°F to 86°F) . store in the original bottle to protect from light and moisture.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

282

Supplements & herbs that interact with Selumetinib

282 supplements and herbal products have documented interactions with Selumetinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 5
  • Moderate · 236
  • Minor · 41
ACTIVATED CHARCOAL Major DANSHEN Major GRAPEFRUIT Major PIRACETAM Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ACONITE Moderate ADRAFINIL Moderate +274 more
Every supplement checked against Selumetinib — ranked by severity The full interaction hub: 5 major · 236 moderate · 41 minor · every one linked to its full report. Check Selumetinib against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Selumetinib: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Selumetinib — the kind of thing our pharmacy team would talk through with you at the counter.

What is selumetinib for?

▾
It treats neurofibromatosis type 1 in adults and children 1 year and older who have symptomatic plexiform neurofibromas that can't be removed by surgery. It works by blocking a growth signal that drives these tumors.

How do I take it?

▾
You take it by mouth twice a day, following the dose your prescriber set for your body size. Capsules are swallowed whole, with or without food. If swallowing capsules is hard, the oral granules are mixed with a little smooth yogurt or fruit puree and eaten within 30 minutes.

What if I miss a dose or throw up?

▾
If you miss a dose, take it unless your next one is due within 6 hours. If you vomit after a dose, don't take another. Just take your next dose at the usual time.

What side effects should I expect?

▾
Vomiting, nausea, diarrhea, rash, dry skin and nail-area infections are common. At the first loose stool, start an anti-diarrheal and drink extra fluids. Call your doctor if you have vision changes, trouble breathing, swelling, severe rash, or muscle pain and weakness.

Will I need tests while taking it?

▾
Yes. You will have heart checks (echocardiograms), eye exams and blood tests for creatine phosphokinase. These help catch problems early so your dose can be adjusted if needed.

Can I take it if I'm pregnant or breastfeeding?

▾
It can harm an unborn baby, so use effective birth control during treatment and for 1 week after your last dose. This applies to men with female partners too. Don't breastfeed during treatment and for 1 week after the last dose.

Is Selumetinib available over the counter?

▾
No. Selumetinib is a prescription medicine: every Selumetinib product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Selumetinib first available?

▾
The earliest FDA record we hold for Selumetinib is from 2020: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Selumetinib was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Selumetinib on HelloPharmacist

📊Selumetinib supplement interactions282 checked — ranked by severity 🌿Drug & Supplement CheckerSelumetinib vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Selumetinib NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Selumetinib Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Selumetinib forms and strengths (how it comes)

Selumetinib is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Koselugo
How this form is used
What it may be used for
  • Koselugo capsules treat NF1 with symptomatic, inoperable plexiform neurofibromas in adults and children 1 year and older.
Important instructions
  • Koselugo capsules are taken by mouth twice daily, with or without food.
  • Swallow Koselugo capsules whole. Do not open, chew or crush them.
  • Koselugo capsules are for people who can swallow a whole capsule.
  • Koselugo capsules contain vitamin E, which may raise bleeding risk with blood thinners or antiplatelet medicines.
Available strengths 4 strengths
5 mg 7.5 mg 10 mg 25 mg
10 FDA-listed product records ⓘ

Oral powder

By mouth
Brands Koselugo
How this form is used
What it may be used for
  • Koselugo oral granules treat NF1 with symptomatic, inoperable plexiform neurofibromas in adults and children 1 year and older who have trouble swallowing whole capsules.
Important instructions
  • Sprinkle Koselugo oral granules on, or mix them with, about 1 to 3 teaspoons of smooth yogurt or apple, banana, pear or strawberry puree, and take within 30 minutes.
  • Do not add Koselugo oral granules to liquids, and do not chew or crush the granules.
  • Do not swallow, chew or dissolve the capsule shells of Koselugo oral granules. Discard empty shells.
  • Do not use Koselugo oral granules if they are clumped or stuck in the shell. Contact your pharmacy.
Available strengths 2 strengths
5 mg 7.5 mg
2 FDA-listed product records ⓘ

Selumetinib on the U.S. market: products, makers and brands

How Selumetinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 4 Selumetinib product records with the FDA, mostly as capsule, oral powder; the earliest marketing or approval year on record is 2020. Brand names on the directory include Koselugo; the rest are generics.

2
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
4
FDA-listed product records ⓘ
2020
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (5) · Granule (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Selumetinib is used (Medicaid data)

A general measure of how commonly Selumetinib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Selumetinib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

3,980
Medicaid prescriptions filled (Q1–Q4 2025)
$58M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Selumetinib prescribed? Of the 1,601 medications we measure, Selumetinib ranks #1,084 by Medicaid prescriptions — more than 32% of them.

Where Selumetinib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,084 of 1,601
#1,079 Epinastine Ophthalmic 4,100 Rx #1,080 Cromolyn Sodium Nasal... 4,088 Rx #1,081 Methazolamide 4,047 Rx #1,082 Teprotumumab-trbw Inje... 4,027 Rx #1,083 Deucravacitinib 4,009 Rx #1,084 Selumetinib 3,980 Rx #1,085 Zanubrutinib 3,956 Rx #1,086 Probenecid 3,947 Rx #1,087 Desoximetasone Topical 3,861 Rx #1,088 Desoximetasone 3,861 Rx #1,089 Cabozantinib (thyroid... 3,853 Rx

Utilization by Selumetinib product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg oral capsule is the most-dispensed Selumetinib product — about 55% of these Medicaid prescriptions.

selumetinib 10 MG Oral Capsule Most dispensed

2,208 Medicaid prescriptions (Q1–Q4 2025) 55% of Selumetinib prescriptions shown $28M gross reimbursement (before rebates) ≈ $12,671 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2289418

selumetinib 25 MG Oral Capsule

1,772 Medicaid prescriptions (Q1–Q4 2025) 45% of Selumetinib prescriptions shown $30M gross reimbursement (before rebates) ≈ $16,916 per prescription (gross)

Summed across the 2 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2289426

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Selumetinib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 4 of 6 listed Selumetinib NDCs with Medicaid activity.

Compare Selumetinib products

A representative set of FDA-listed product records for Selumetinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
10 mg Oral AstraZeneca Pharmaceuticals LP NDA View NDC →
25 mg Oral AstraZeneca Pharmaceuticals LP NDA View NDC →
💊Oral powder
5 mg Oral AstraZeneca Pharmaceuticals LP NDA View NDC →
7.5 mg Oral AstraZeneca Pharmaceuticals LP NDA View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Selumetinib NDCs →

Selumetinib recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Selumetinib recalls since July 2021.

✅No Selumetinib recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Selumetinib RxCUI 2289380 2 dose forms · 4 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 2289417 In current FDA listings
    Clinical drug / strength (SCD) 10 MG RxCUI 2289418 25 MG RxCUI 2289426
  2. Dose form (SCDF) Oral Granules RxCUI 2723652 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 2723653 7.5 MG RxCUI 2723659

Look up RxCUI 2289380 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Selumetinib brand names

Selumetinib is sold under one brand name in the FDA directory — Koselugo. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Koselugo

Who makes Selumetinib: manufacturers and labelers

One company lists Selumetinib products with the FDA. By number of product records, the largest are AstraZeneca Pharmaceuticals LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

AstraZeneca Pharmaceuticals LP 4

Selumetinib drug class (RxNorm)

Selumetinib belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Mitogen-activated protein kinase (MEK) inhibitors
How it works Mitogen-Activated Protein Kinase Kinase 1 Inhibitors, Mitogen-Activated Protein Kinase Kinase 2 Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Selumetinib page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

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FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 26, 2026
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Selumetinib.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Selumetinib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
4
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
AstraZeneca Pharmaceuticals LP
Linked label effective
May 26, 2026
Composite sections available
22
Linked SPL Set ID
7d042c61-f28f-4ab5-ab10-d7558c0d49ff
Linked SPL Document ID
bdebc47d-8420-42eb-aaa7-b243dc9e42b2
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. AstraZeneca Pharmaceuticals LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →