Vandetanib
Vandetanib is a once-daily kinase inhibitor cancer medicine used to treat symptomatic or progressive medullary thyroid cancer that cannot be removed by surgery and has spread locally or to other parts of the body.
🧬 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 →
Vandetanib (Caprelsa) is a specialist cancer drug for medullary thyroid cancer that is growing or causing symptoms and cannot be removed by surgery. It blocks several enzymes, including RET, that tumors use to grow and build new blood vessels, and it has been on the U.S. market since about 2011. It is a demanding medicine; diarrhea, an acne-like rash and higher blood pressure are what people notice most. Its boxed warning is for QT prolongation (a heart rhythm change seen on an ECG) that can trigger torsades de pointes, a dangerous rhythm, and sudden death, so expect regular ECGs, potassium, calcium and magnesium checks, and a review of every other medicine.
Clinical pearls
- Report fainting, a racing heartbeat, a blistering rash, new cough or breathlessness, or coughing up blood right away.
- Treat diarrhea early and call if it persists, since it can drain potassium and magnesium and raise heart rhythm risk.
- Use sunscreen and cover up outdoors, because sun sensitivity can last up to four months after the last dose.
- Tell any surgeon or dentist, since treatment is paused at least one month before elective surgery or dental surgery.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Vandetanib can cause a dangerous heart rhythm problem (QT prolongation and torsades de pointes) that can lead to sudden death.
Do not use it if you have long QT syndrome or low blood calcium, potassium or magnesium. Those levels must be corrected before you start and checked regularly. Avoid other medicines that can affect the QT interval. Report fainting, dizziness or a fast or irregular heartbeat right away.
Patient information guide A plain-language walkthrough of Vandetanib, written from its FDA label.
What Vandetanib is used for
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Vandetanib is used for one cancer type.
- Caprelsa is used for symptomatic or progressive medullary thyroid cancer in people with unresectable locally advanced or metastatic disease.
- For slow-growing, symptom-free disease, it is used only after careful weighing of its risks.
How Vandetanib works
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Vandetanib blocks several tyrosine kinases, including EGFR, VEGFR and RET. These signaling proteins help tumors grow, spread and form new blood vessels.
In lab and mouse studies, it reduced tumor blood vessel growth and slowed tumor growth and spread. Its main breakdown product has similar activity against VEGF receptors and EGFR.
Vandetanib dosage
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Caprelsa is a tablet taken by mouth once daily, with or without food. It continues until the cancer progresses or toxicity becomes unacceptable.
- If you miss a dose, do not take it within 12 hours of the next one.
- Do not crush tablets. They can be dispersed in plain water and swallowed right away.
- Your doctor may lower the dose or pause treatment for serious side effects or QT prolongation.
Dosing details from the FDA-approved label
From the Vandetanib 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.
- Recommended dose (indication not named in the text)
- 300 mg taken orally once daily until disease progression or unacceptable toxicity occurs
- May be taken with or without food. Do not take a missed dose within 12 hours of the next dose. Do not crush tablets; tablets can be dispersed in 2 ounces of water.
- Dosage adjustment for adverse reactions (CTCAE Grade 3 or greater toxicities)
- The 300 mg daily dose can be reduced to 200 mg (two 100 mg tablets) and then to 100 mg
- For recurrent toxicities, reduce to 100 mg after resolution or improvement to CTCAE Grade 1 severity, if continued treatment is warranted
- Interrupt for QTcF greater than 500 ms and resume at a reduced dose when QTcF returns to less than 450 ms; interrupt for Grade 3 or greater toxicity and resume at a reduced dose when it resolves or improves to Grade 1
- Patients with moderate renal impairment (creatinine clearance ≥30 to
- Reduce the starting dose to 200 mg
- Label text is cut off after creatinine clearance ≥30 to
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION The recommended dose of CAPRELSA is 300 mg taken orally once daily until disease progression or unacceptable toxicity occurs. CAPRELSA may be taken with or without food. Do not take a missed dose within 12 hours of the next dose. Do not crush CAPRELSA tablets. The tablets can be dispersed in 2 ounces of water by stirring for approximately 10 minutes (will not completely dissolve). Do not use other liquids for dispersion. Swallow immediately after dispersion. Mix any remaining residue with 4 additional ounces of water and swallow. The dispersion can also be administered through nasogastric or gastrostomy tubes. 300 mg once daily. ( 2 ) CAPRELSA may be taken with or without food. ( 2 ) Dosage reduction may be necessary in the event of severe toxicities or QTc interval prolongation. ( 2.1 ) The starting dose is 200 mg in patients with moderate renal impairment. ( 2.1 ) 2.1 Dosage Adjustment For Adverse Reactions The 300 mg daily dose can be reduced to 200 mg (two 100 mg tablets) and then to 100 mg for Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or greater toxicities. Interrupt CAPRELSA for the following: Corrected QT interval, Fridericia (QTcF) greater than 500 ms: Resume at a reduced dose when the QTcF returns to less than 450 ms. CTCAE Grade 3 or greater toxicity: Resume at a reduced dose when the toxicity resolves or improves to CTCAE Grade 1. For recurrent toxicities, reduce the dose of CAPRELSA to 100 mg after resolution or improvement to CTCAE Grade 1 severity, if continued treatment is warranted. Adverse events including QT interval prolongation should be monitored closely as they may not resolve fully until approximately three plasma half-lives of the drug. Monitor appropriately [see Warnings and Precautions (5.1) , (5.2) , (5.3) , (5.4) , (5.5) , (5.6) , (5.7) , and (5.9) ] . For Patients with Renal Impairment Reduce the starting dose to 200 mg in patients with moderate (creatinine clearance ≥30 to <50 mL/min) renal impairment [see Warnings and Precautions (5.12) and Use in Specific Populations (8.6) ] . For Patients with Hepatic Impairment CAPRELSA is not recommended for use in patients with moderate and severe hepatic impairment [see Use in Specific Populations (8.7) ] .
Read the full Dosage and Administration section on DailyMed →
Vandetanib side effects
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The most common side effects in studies were:
Common side effects
- Diarrhea or colitis (inflamed bowel)
- Rash and acne-like skin reactions
- High blood pressure
- Nausea
- Headache
- Upper respiratory tract infections
- Decreased appetite
- Abdominal pain
When to get medical help
- Fainting, a racing or irregular heartbeat, or dizziness (possible dangerous heart rhythm problems)
- Severe skin reactions such as blistering, peeling or widespread rash (can be fatal)
- New or worsening cough or breathing trouble (possible interstitial lung disease)
- Signs of stroke or severe bleeding, including coughing up red blood
- Symptoms of heart failure, such as swelling or shortness of breath
- Severe or ongoing diarrhea, which can lead to dehydration and heart rhythm risks
- Seizures, severe headache, vision changes or confusion (possible reversible posterior leukoencephalopathy syndrome)
- Very high blood pressure
Serious reactions include dangerous heart rhythms, severe skin reactions, lung disease, bleeding, stroke, heart failure and kidney failure. Call your doctor promptly if you notice warning signs.
Vandetanib warnings and precautions
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- QT prolongation and torsades de pointes can cause sudden death. ECGs and blood tests are needed at baseline, at 2 to 4 weeks, at 8 to 12 weeks, and every 3 months afterward.
- Severe skin reactions (including Stevens-Johnson syndrome and toxic epidermal necrolysis) and sun sensitivity can occur.
- Interstitial lung disease, stroke, bleeding, heart failure, severe diarrhea and high blood pressure have occurred.
- Underactive thyroid: nearly half of treated patients needed more thyroid replacement.
- Slow wound healing: stop at least 1 month before elective surgery.
- Jaw osteonecrosis: avoid invasive dental procedures and stop at least 1 month before dental surgery.
- Corneal changes can cause halos or reduced vision.
Vandetanib interactions
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Several medicines and supplements can change vandetanib's safety or effectiveness.
- QT-prolonging drugs (such as amiodarone, sotalol, haloperidol, methadone, moxifloxacin, clarithromycin): add to heart rhythm risk.
- Strong CYP3A4 inducers (such as rifampicin): can lower vandetanib levels.
- St. John's wort: can lower levels unpredictably.
- Metformin and other OCT2-transported drugs: levels may rise.
- Digoxin: levels may rise, so close monitoring is needed.
Interactions listed in the FDA-approved label
From the Vandetanib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Strong CYP3A4 inducers (e.g., rifampicin): Rifampicin, a strong CYP3A4 inducer, decreased vandetanib plasma concentrations. Avoid concomitant use of known strong CYP3A4 inducers during CAPRELSA therapy.
- St. John's wort: It can decrease vandetanib exposure unpredictably. Avoid concomitant use of St. John's wort.
- Drugs transported by OCT2 (e.g., metformin): CAPRELSA increased plasma concentrations of metformin, which is transported by the organic cation transporter type 2 (OCT2). Use caution and closely monitor for toxicities when administering CAPRELSA with drugs transported by OCT2.
- Digoxin: CAPRELSA increased plasma concentrations of digoxin. Use caution and closely monitor for toxicities when administering CAPRELSA with digoxin.
- Drugs that prolong the QT interval: Agents that may prolong the QT interval are a concern when used with CAPRELSA. Avoid concomitant use of CAPRELSA with agents that may prolong the QT interval.
Read the label’s full interactions text
7 DRUG INTERACTIONS Avoid the use of strong CYP3A4 inducers because they may decrease CAPRELSA exposure. ( 7.1 ) Avoid the use of agents that prolong the QT interval. ( 5.11 ) 7.1 Effect of CYP3A4 Inducers on CAPRELSA Rifampicin, a strong CYP3A4 inducer, decreased vandetanib plasma concentrations. Avoid concomitant use of known strong CYP3A4 inducers during CAPRELSA therapy. Avoid concomitant use of St. John's wort because it can decrease vandetanib exposure unpredictably [see Clinical Pharmacology (12.3) ] . 7.2 Effect of CAPRELSA on OCT2 Transporter CAPRELSA increased plasma concentrations of metformin that is transported by the organic cation transporter type 2 (OCT2). Use caution and closely monitor for toxicities when administering CAPRELSA with drugs that are transported by OCT2 [see Clinical Pharmacology (12.3) ] . 7.3 Effect of CAPRELSA on Digoxin CAPRELSA increased plasma concentrations of digoxin. Use caution and closely monitor for toxicities when administering CAPRELSA with digoxin [see Clinical Pharmacology (12.3) ] . 7.4 Drugs that Prolong the QT Interval Avoid concomitant use of CAPRELSA with agents that may prolong the QT interval [see Warnings and Precautions (5.11) ] .
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.
Before taking Vandetanib
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- Do not use with congenital long QT syndrome or uncorrected low calcium, potassium or magnesium.
- Tell your doctor about a history of torsades de pointes, a slow heartbeat, uncontrolled heart failure or recent coughing up of red blood.
- Moderate kidney impairment requires a lower starting dose; severe impairment is not recommended.
- Moderate or severe liver impairment: not recommended.
- Pregnancy: can cause fetal harm. Use effective contraception during treatment and for 4 months after the last dose.
- Do not breastfeed during treatment and for 4 months after the last dose.
- Not established in children. Too few people 65 and older were studied to compare responses.
Vandetanib overdose
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In an overdose, you should be monitored closely for QT prolongation. Side effects, including QT changes, may not fully resolve for a long time because the drug stays in the body so long.
What Vandetanib does in the body
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Vandetanib causes QT prolongation that depends on how much drug is in the blood. At the usual dose in a major trial, the average QTcF rose by about 35 ms and stayed above 30 ms for up to 2 years. About 36% of patients had an increase over 60 ms, and 4.3% had a QTcF above 500 ms.
How your body processes Vandetanib
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Absorption is slow, with peak levels around 6 hours after a dose, and food does not change exposure. The drug builds up in the body and reaches steady state in about 3 months. Its median half-life is about 19 days.
It is broken down partly by CYP3A4 and FMO enzymes and cleared slowly through feces and urine. Exposure is higher in people with reduced kidney function.
How to store Vandetanib
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stored at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted to 59°F–86°F (15°C-30°C) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Vandetanib
146 supplements and herbal products have documented interactions with Vandetanib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 8
- Moderate · 98
- Minor · 40
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.
Vandetanib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Vandetanib — the kind of thing our pharmacy team would talk through with you at the counter.
What is vandetanib used for?
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How do I take it?
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Why do I need so many heart tests and blood tests?
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What side effects should I expect, and which should I call about?
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Can I take my other medicines and supplements with it?
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What about pregnancy and sun exposure?
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Is Vandetanib available over the counter?
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When was Vandetanib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Vandetanib on HelloPharmacist
Vandetanib forms and strengths (how it comes)
Vandetanib is available in 1 form. 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.
Tablet
How this form is used
- Caprelsa is used for symptomatic or progressive medullary thyroid cancer that is unresectable and locally advanced or metastatic.
- Caprelsa is taken by mouth once daily, with or without food.
- Do not crush Caprelsa tablets.
- Caprelsa tablets can be stirred into 2 ounces of plain water for about 10 minutes, then swallowed right away.
- The Caprelsa dispersion can also be given through a nasogastric or gastrostomy tube.
Vandetanib on the U.S. market: products, makers and brands
How Vandetanib 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 2 Vandetanib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2011. Brand names on the directory include Caprelsa; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Vandetanib products
A representative set of FDA-listed product records for Vandetanib — 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 |
|---|---|---|---|---|
| 💊Tablet | ||||
| 100 mg | Oral | Genzyme Corporation | NDA | View NDC → |
| 300 mg | Oral | Genzyme Corporation | NDA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Vandetanib NDCs →
Vandetanib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Vandetanib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Vandetanib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Vandetanib FDA approval history
How Vandetanib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Vandetanib 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 Vandetanib recalls since July 2021.
✅No Vandetanib recalls on record since July 2021Source: 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.
RxCUI 1098413 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 1098415In current FDA listings
Look up RxCUI 1098413 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.
Vandetanib supply and shortage status
Whether Vandetanib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Vandetanib brand names
Vandetanib is sold under one brand name in the FDA directory — Caprelsa. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Vandetanib: manufacturers and labelers
One company lists Vandetanib products with the FDA. By number of product records, the largest are Genzyme Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Vandetanib drug class (RxNorm)
Vandetanib belongs to the Kinase Inhibitor class.
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 Vandetanib 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.
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. Genzyme 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 →