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Dabrafenib

Dabrafenib is a targeted cancer medicine (a kinase inhibitor) for cancers with a BRAF V600 mutation, including melanoma, non-small cell lung cancer, anaplastic thyroid cancer, other solid tumors and pediatric low-grade glioma.

Brand name Tafinlar
Drug classes Breast Cancer Resistance Protein Inhibitors
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
Dabrafenib 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

Dabrafenib (Tafinlar) is a specialist targeted cancer drug, on the U.S. market for roughly a decade, that blocks a faulty BRAF protein in melanoma, non-small cell lung cancer, anaplastic thyroid cancer, low-grade glioma in children and other solid tumors carrying a BRAF V600 mutation, usually paired with trametinib, which blocks the next step in the same growth signal. Most people can stay on it, though fever and chills are its signature side effects, especially with trametinib, alongside tiredness, headache, joint pain and rash. If your temperature reaches 100.4°F or higher, call your cancer team promptly, because the dose may need pausing.

Clinical pearls

  • Take it on an empty stomach, at least 1 hour before or 2 hours after a meal, about 12 hours apart.
  • It can make hormonal birth control fail, so use a non-hormonal method during treatment and for 2 weeks after.
  • Expect skin checks before starting, about every 2 months on treatment and up to 6 months after, to spot new skin cancers.
  • Report eye pain, light sensitivity or vision changes, and unusual bleeding like black stools, right away.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asCapsule, Tablet
Earliest FDA record2013
Companies listing it with the FDA1
FDA label last updatedMay 20, 2026
FDA’s strongest warning (boxed)None on the label

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

What Dabrafenib is used for

▾

Dabrafenib (Tafinlar) treats cancers with a BRAF V600 mutation.

  • Tafinlar alone: unresectable or metastatic melanoma with BRAF V600E mutation.
  • With trametinib: unresectable or metastatic melanoma with BRAF V600E or V600K mutations.
  • With trametinib: adjuvant (after surgery) treatment of melanoma with V600E or V600K mutations and lymph node involvement, after complete resection.
  • With trametinib: metastatic non-small cell lung cancer with BRAF V600E mutation.
  • With trametinib: locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E mutation and no satisfactory locoregional treatment options.
  • With trametinib: unresectable or metastatic solid tumors with BRAF V600E mutation in adults and children 1 year and older who have progressed after prior treatment and have no satisfactory alternatives. This is an accelerated approval, and continued approval may depend on confirmatory trials.
  • With trametinib: low-grade glioma with BRAF V600E mutation in children 1 year and older who need systemic therapy.
  • Not for colorectal cancer or tumors with normal (wild-type) BRAF.

How Dabrafenib works

▾

Dabrafenib blocks mutated BRAF kinases, proteins that can be stuck in the “on” position and push tumor cells to grow. Blocking them slows the growth of BRAF V600 mutation-positive tumors.

Trametinib targets a different protein in the same signaling pathway. Together they worked better than either alone in lab studies. In BRAF-mutant colorectal cancer, the pathway switches back on, which is why dabrafenib is not used there.

Dabrafenib dosage

▾

Tafinlar is taken by mouth twice daily, about 12 hours apart, on an empty stomach (1 hour before or 2 hours after a meal). It comes as capsules and as tablets for oral suspension, and they are dosed differently, so follow your own prescription.

  • Do not open, crush or break the capsules.
  • Do not swallow, chew or crush the tablets for oral suspension. Dissolve them in water.
  • If you miss a dose, skip it if your next dose is within 6 hours.
  • If you vomit, do not take an extra dose.

Treatment generally continues until the cancer progresses or side effects are unacceptable. Adjuvant melanoma treatment lasts up to 1 year.

Dosing details from the FDA-approved label

From the Dabrafenib 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 patients (TAFINLAR capsules)
    • 150 mg taken orally twice daily
    • Take at least 1 hour before or 2 hours after a meal
  • Pediatric patients weighing 26 to 37 kg (TAFINLAR capsules)
    • 75 mg orally twice daily
    • A recommended dosage of capsules has not been established in patients who weigh less than 26 kg
  • Pediatric patients weighing 38 to 50 kg (TAFINLAR capsules)
    • 100 mg orally twice daily
    • Weight-based dosing
  • Pediatric patients weighing 51 kg or greater (TAFINLAR capsules)
    • 150 mg orally twice daily
    • Weight-based dosing
  • Adult and pediatric patients, tablets for oral suspension, 8 to 9 kg
    • 20 mg twice daily
    • 10 to 13 kg: 30 mg twice daily; 14 to 17 kg: 40 mg twice daily; 18 to 21 kg: 50 mg twice daily
  • Adult and pediatric patients, tablets for oral suspension, 22 to 37 kg
    • 22 to 25 kg: 60 mg twice daily
    • 26 to 29 kg: 70 mg twice daily
    • 30 to 33 kg: 80 mg twice daily
    • 34 to 37 kg: 90 mg twice daily
    • Take on an empty stomach (at least 1 hour before or 2 hours after a meal)
  • Adult and pediatric patients, tablets for oral suspension, 38 to 50 kg
    • 38 to 41 kg: 100 mg twice daily
    • 42 to 45 kg: 110 mg twice daily
    • 46 to 50 kg: 130 mg twice daily
    • Weight-based dosing
  • Adult and pediatric patients, tablets for oral suspension, 51 kg or greater
    • 150 mg twice daily
    • Weight-based dosing
  • Unresectable or metastatic melanoma or solid tumors, metastatic NSCLC, locally advanced or metastatic anaplastic thyroid cancer (duration)
    • Treat until disease progression or unacceptable toxicity
  • Adjuvant melanoma (duration)
    • Treat until disease recurrence or unacceptable toxicity for up to 1 year
    • Maximum: up to 1 year
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION The recommended dosage of TAFINLAR in adult patients is 150 mg (two 75 mg capsules) orally twice daily. The recommended dosage for TAFINLAR in pediatric patients is based on body weight. Take TAFINLAR at least 1 hour before or 2 hours after a meal. ( 2 ) 2.1 Patient Selection Melanoma Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR as a single agent [see Warnings and Precautions (5.2), Clinical Studies (14.1)] . Confirm the presence of BRAF V600E or V600K mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Warnings and Precautions (5.2), Clinical Studies (14.2, 14.3)] . Information on FDA-approved tests for the detection of BRAF V600 mutations in melanoma is available at: http://www.fda.gov/CompanionDiagnostics . NSCLC Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies (14.4)] . Information on FDA-approved tests for the detection of BRAF V600E mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics . ATC Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies (14.5)] . Information on FDA-approved tests for the detection of BRAF V600E mutations in ATC is available at: http://www.fda.gov/CompanionDiagnostics . Solid Tumors Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies (14.6)] . An FDA-approved test for the detection of BRAF V600E mutation in solid tumors other than melanoma and NSCLC is not currently available. Low-Grade Glioma Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment with TAFINLAR and trametinib [see Clinical Studies (14.7)] . An FDA-approved test for the detection of BRAF V600E mutation in LGG is not currently available. 2.2 Recommended Dosage TAFINLAR Capsules Adult Patients The recommended dosage for TAFINLAR capsules in adult patients is 150 mg taken orally twice daily [see Dosage and Administration (2.3)] .

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

Dabrafenib side effects

▾

Side effects depend on whether it is taken alone or with trametinib.

Common side effects

  • Fever (pyrexia)
  • Headache
  • Joint pain
  • Rash
  • Chills
  • Fatigue
  • Nausea, vomiting or diarrhea
  • Cough
  • Rash and dry skin
  • Thickened skin, warts (papillomas), hair loss and hand-foot skin reaction when taken alone

When to get medical help

  • Fever of 100.4°F or higher: call your doctor, because it may mean the medicine needs to be paused, and fever can come with chills, low blood pressure, dehydration or kidney problems.
  • Any unusual bleeding, including black stools, vomiting blood, severe headache or nosebleeds that do not stop.
  • Vision changes, eye pain or sensitivity to light, which can signal uveitis (eye inflammation).
  • New or changing skin growths, or a new or worsening rash, blisters, peeling or mouth sores.
  • Shortness of breath, swelling or new tiredness, which may signal a heart muscle problem (cardiomyopathy).
  • Very high blood sugar symptoms, especially if you have diabetes.
  • Signs of hemolytic anemia (red blood cells breaking down) if you have G6PD deficiency.

Dabrafenib warnings and precautions

▾
  • New cancers: skin cancers and other cancers can occur. Skin exams are needed before, during and after treatment.
  • Fever: serious fever can bring low blood pressure, dehydration or kidney problems.
  • Bleeding: major and sometimes fatal bleeding can occur with trametinib.
  • Heart: heart pumping function is checked before treatment, after one month, then every 2 to 3 months.
  • Eyes: uveitis can occur. Tell your doctor about any vision changes.
  • Skin: severe reactions such as Stevens-Johnson syndrome and DRESS can be life-threatening.
  • Blood sugar: may rise, especially in people with diabetes.
  • G6PD deficiency: risk of hemolytic anemia.
  • HLH: a rare immune condition reported with trametinib.
  • Pregnancy: can cause fetal harm.

Dabrafenib interactions

▾

Dabrafenib is processed by liver enzymes and also changes how other drugs work.

  • Strong CYP3A4 or CYP2C8 inhibitors (such as ketoconazole, gemfibrozil): raise dabrafenib levels.
  • Warfarin: levels drop, so INR is checked more often.
  • Hormonal contraceptives: can be rendered ineffective.
  • Dexamethasone and other sensitive CYP substrates: may lose effectiveness.

Interactions listed in the FDA-approved label

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

  • Strong inhibitors of CYP3A4 or CYP2C8: May increase the concentration of dabrafenib. Avoid concurrent administration; substitution is recommended. If unavoidable, monitor patients closely for adverse reactions.
  • Sensitive substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19, or CYP2B6: Concomitant use may result in loss of efficacy of these agents. Substitute for these medications or monitor patients for loss of efficacy if use is unavoidable.
  • Warfarin: Dabrafenib decreased the systemic exposures of S-warfarin (a CYP2C9 substrate) and R-warfarin (a CYP3A4/CYP1A2 substrate). Monitor INR levels more frequently during initiation or discontinuation of dabrafenib.
  • Midazolam: Dabrafenib decreased the systemic exposure of midazolam (a CYP3A4 substrate). Substitute for these medications or monitor patients for loss of efficacy if use is unavoidable.
  • Dexamethasone: Coadministration can result in decreased concentrations and loss of efficacy. Substitute for this medication or monitor patients for loss of efficacy if use is unavoidable.
  • Hormonal contraceptives: Coadministration can result in decreased concentrations and loss of efficacy. Substitute for these medications or monitor patients for loss of efficacy if use is unavoidable.
Read the label’s full interactions text

7 DRUG INTERACTIONS Avoid concurrent administration of strong inhibitors of CYP3A4 or CYP2C8. ( 7.1 ) Concomitant use with agents that are sensitive substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19, or CYP2B6 may result in loss of efficacy of these agents. ( 7.2 ) 7.1 Effects of Other Drugs on TAFINLAR Strong inhibitors of CYP3A4 or CYP2C8 may increase the concentration of dabrafenib [see Clinical Pharmacology (12.3)] . Substitution of strong inhibitors of CYP3A4 or CYP2C8 is recommended during treatment with TAFINLAR. If concomitant use of strong inhibitors of CYP3A4 or CYP2C8 is unavoidable, monitor patients closely for adverse reactions when taking strong inhibitors. 7.2 Effects of TAFINLAR on Other Drugs Dabrafenib decreased the systemic exposures of midazolam (a CYP3A4 substrate), S-warfarin (a CYP2C9 substrate), and R-warfarin (a CYP3A4/CYP1A2 substrate) [see Clinical Pharmacology (12.3)] . Monitor international normalized ratio (INR) levels more frequently in patients receiving warfarin during initiation or discontinuation of dabrafenib. Coadministration of TAFINLAR with other substrates of these enzymes, including dexamethasone or hormonal contraceptives , can result in decreased concentrations and loss of efficacy [see Use in Specific Populations (8.1, 8. 3 )] . Substitute for these medications or monitor patients for loss of efficacy if use of these medications is unavoidable.

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.

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

Before taking Dabrafenib

▾
  • Pregnancy: can cause fetal harm. Check pregnancy status first and use non-hormonal contraception during treatment and for 2 weeks after.
  • Males with partners who could become pregnant: use condoms during treatment and for 2 weeks after.
  • Breastfeeding: do not breastfeed during treatment and for 2 weeks after.
  • Fertility: may be impaired in women and men, and sperm effects may be irreversible.
  • Children: established only with trametinib, for ages 1 year and older, for certain tumors.
  • Older adults: no overall difference in effectiveness or safety was seen in melanoma studies.
  • Liver: moderate to severe liver impairment may raise drug levels, and no appropriate dose is established.
  • No contraindications are listed.

Dabrafenib overdose

▾

There is no information on overdose of Tafinlar. Because dabrafenib is highly bound to proteins in the blood, dialysis is likely ineffective. Contact poison control or seek emergency care if you take too much.

What Dabrafenib does in the body

▾

In a dedicated study, dabrafenib at twice the recommended dose did not cause large changes in the QT interval, a measure of heart rhythm timing. In trials, a small percentage of patients had QTc prolongation to 500 ms or more (0.8% with trametinib, 1.5% alone).

How your body processes Dabrafenib

▾

Peak levels occur about 2 hours after a dose. Bioavailability is 95% for the capsules and 76% for the tablets for oral suspension. Food lowers absorption, which is why it is taken on an empty stomach.

The liver breaks dabrafenib down mainly through CYP2C8 and CYP3A4. Its half-life is about 8 hours. Most is removed in the stool (71%), and some in the urine (23%) as metabolites.

How to store Dabrafenib

▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) . Store and dispense in the original bottle with the desiccant.

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

154

Supplements & herbs that interact with Dabrafenib

154 supplements and herbal products have documented interactions with Dabrafenib 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 · 3
  • Moderate · 112
  • Minor · 39
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate ALKANNA Moderate ALPINE RAGWORT Moderate +146 more
Every supplement checked against Dabrafenib — ranked by severity The full interaction hub: 3 major · 112 moderate · 39 minor · every one linked to its full report. Check Dabrafenib 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.

Dabrafenib: pharmacist answers to common questions

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

What is dabrafenib for?

▾
It treats cancers with a BRAF V600 mutation, such as melanoma, non-small cell lung cancer, anaplastic thyroid cancer, other solid tumors and low-grade glioma in children. It is often taken with trametinib. Your tumor is tested for the mutation first.

How should I take it?

▾
Take it twice a day, about 12 hours apart, on an empty stomach, 1 hour before or 2 hours after eating. Do not open or crush the capsules. If you vomit, do not take an extra dose. Follow your prescription for the exact amount.

What side effects should I expect?

▾
Fever, chills, headache, rash, joint pain, tiredness and stomach upset are common. Call your doctor if your temperature reaches 100.4°F, since your medicine may need to be paused.

When should I call my doctor right away?

▾
Call for unusual bleeding, vision changes or eye pain, a severe rash or blistering, new skin growths, shortness of breath or swelling, or very high blood sugar symptoms. These can be serious and need prompt attention.

Can I use birth control or take other medicines with it?

▾
Dabrafenib can make hormonal birth control stop working, so you need a non-hormonal method. It can also lower warfarin levels, and some other drugs can raise or lower dabrafenib. Tell me about everything you take, including prescriptions and supplements.

Is it safe during pregnancy or breastfeeding?

▾
It can harm an unborn baby, so avoid pregnancy and do not breastfeed during treatment and for 2 weeks after your last dose. Men with partners who could become pregnant should use condoms. Talk with your doctor about fertility concerns too.

Is Dabrafenib available over the counter?

▾
No. Dabrafenib is a prescription medicine: every Dabrafenib 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 Dabrafenib first available?

▾
The earliest FDA record we hold for Dabrafenib is from 2013: 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 Dabrafenib was first used.

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

More about Dabrafenib on HelloPharmacist

📊Dabrafenib supplement interactions154 checked — ranked by severity 🌿Drug & Supplement CheckerDabrafenib vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Dabrafenib NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Dabrafenib 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.

Dabrafenib forms and strengths (how it comes)

Dabrafenib 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 Tafinlar
How this form is used
What it may be used for
  • Tafinlar is used for adults and for children who weigh at least 26 kg, for the approved BRAF-mutation cancers.
Important instructions
  • Tafinlar capsules are taken on an empty stomach, at least 1 hour before or 2 hours after a meal.
  • Do not open, crush or break Tafinlar capsules.
Available strengths 2 strengths
50 mg 75 mg
8 FDA-listed product records ⓘ

Tablet

By mouth
Brands Tafinlar
How this form is used
What it may be used for
  • Tafinlar tablets for oral suspension are dosed by body weight for adults and children.
Important instructions
  • Tafinlar tablets for oral suspension are taken on an empty stomach, at least 1 hour before or 2 hours after a meal.
  • Do not swallow whole, chew or crush Tafinlar tablets for oral suspension. Dissolve them in water as instructed.
  • Give the prepared Tafinlar suspension right away. Discard it if not given within 30 minutes.
  • Breastfeeding or formula may be given on demand if a child cannot tolerate fasting while taking Tafinlar tablets for oral suspension.
Available strengths 1 strength
10 mg
3 FDA-listed product records ⓘ

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

How Dabrafenib 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 3 Dabrafenib product records with the FDA, mostly as capsule, tablet; the earliest marketing or approval year on record is 2013. Brand names on the directory include Tafinlar; the rest are generics.

2
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
3
FDA-listed product records ⓘ
2013
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 (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Dabrafenib is used (Medicaid data)

A general measure of how commonly Dabrafenib 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 Dabrafenib 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.

2,673
Medicaid prescriptions filled (Q1–Q4 2025)
$36.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Dabrafenib prescribed? Of the 1,601 medications we measure, Dabrafenib ranks #1,149 by Medicaid prescriptions — more than 28% of them.

Where Dabrafenib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,149 of 1,601
#1,144 Dasiglucagon Injection 2,752 Rx #1,145 Ketorolac / Phenylephr... 2,724 Rx #1,146 Ibrutinib 2,698 Rx #1,147 Canagliflozin / Metfor... 2,694 Rx #1,148 Phenol 2,689 Rx #1,149 Dabrafenib 2,673 Rx #1,150 Prasterone Vaginal 2,624 Rx #1,151 Mifepristone (Mifeprex... 2,590 Rx #1,152 Mifepristone (Korlym) 2,590 Rx #1,153 Deferiprone 2,586 Rx #1,154 Calcifediol 2,586 Rx

Utilization by Dabrafenib 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 75 mg oral capsule is the most-dispensed Dabrafenib product — about 80% of these Medicaid prescriptions.

dabrafenib 75 MG Oral Capsule Most dispensed

2,133 Medicaid prescriptions (Q1–Q4 2025) 80% of Dabrafenib prescriptions shown $31.7M gross reimbursement (before rebates) ≈ $14,847 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1424918

dabrafenib 50 MG Oral Capsule

279 Medicaid prescriptions (Q1–Q4 2025) 10% of Dabrafenib prescriptions shown $3.2M gross reimbursement (before rebates) ≈ $11,412 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1424916

dabrafenib 10 MG Tablet for Oral Suspension

261 Medicaid prescriptions (Q1–Q4 2025) 10% of Dabrafenib prescriptions shown $2M gross reimbursement (before rebates) ≈ $7,584 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2632552

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 Dabrafenib, 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 3 of 6 listed Dabrafenib NDCs with Medicaid activity.

Compare Dabrafenib products

A representative set of FDA-listed product records for Dabrafenib — 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
50 mg Oral Novartis Pharmaceuticals Corporation NDA View NDC →
75 mg Oral Novartis Pharmaceuticals Corporation NDA View NDC →
💊Tablet
10 mg Oral Novartis Pharmaceuticals Corporation NDA View NDC →

Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Dabrafenib NDCs →

Dabrafenib 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 Dabrafenib recalls since July 2021.

✅No Dabrafenib 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) Dabrafenib RxCUI 1424911 2 dose forms · 3 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 1424915 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 1424916 75 MG RxCUI 1424918
  2. Dose form (SCDF) Tablet for Oral Suspension RxCUI 2632551 In current FDA listings
    Clinical drug / strength (SCD) 10 MG RxCUI 2632552

Look up RxCUI 1424911 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.

Dabrafenib brand names

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

Tafinlar

Who makes Dabrafenib: manufacturers and labelers

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

Novartis Pharmaceuticals Corporation 3

Dabrafenib drug class (RxNorm)

Dabrafenib belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) B-Raf serine-threonine kinase (BRAF) inhibitors
How it works Protein Kinase Inhibitors, Cytochrome P450 3A4 Inducers, Cytochrome P450 2C9 Inducers, Cytochrome P450 2C19 Inducers

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 Dabrafenib 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.

📄
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 20, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Dabrafenib.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Dabrafenib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
3
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Novartis Pharmaceuticals Corporation
Linked label effective
May 20, 2026
Composite sections available
23
Linked SPL Set ID
fee1e6b1-e1a5-4254-9f2e-a70e0f8dbdea
Linked SPL Document ID
6c546993-1f7f-409b-b108-60f22e9b948a
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. Novartis Pharmaceuticals Corporation 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 →