Prescription medicine
Vandetanib Brand names: Caprelsa
Vandetanib (Caprelsa) is a prescription medicine with an FDA approval on record since 2011. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the vandetanib FDA label on DailyMed (effective April 23, 2026, Genzyme Corporation); the NDA 22405 record on Drugs@FDA; every vandetanib label on DailyMed.
Highlights of the record
FDA label of April 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH.
CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypocalcemia, hypokalemia and/or hypomagnesemia prior to CAPRELSA administration. Monitor electrolytes periodically. Avoid drugs known to prolong the QT interval [see Warnings and Precautions (5.1) ]. WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH See full prescribing information for complete boxed warning. CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Do not use CAPRELSA in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Correct hypocalcemia, hypokalemia and/or hypomagnesemia prior to CAPRELSA administration. Monitor electrolytes periodically. Avoid drugs known to prolong the QT interval ( 5.1 ).
Used for
From the label: indications and usageCAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
Forms and strengths
- 100 mg
- 300 mg
Film-coated tablet.
On the market
- Earliest approval on file
- April 6, 2011 Caprelsa, Genzyme Corp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 8, 2028 Caprelsa tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,794 through July 30, 2026
What is vandetanib used for?
From the label: indications and usageCAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA. CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. ( 1 ) Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (CAPRELSA), Genzyme Corporation, effective April 23, 2026 (SPL set e5721cb8-4185-47b9-bbb3-1c587e558a03), via openFDA; the full label on DailyMed
What does the patient leaflet for vandetanib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about CAPRELSA?CAPRELSA can cause a change in the electrical activity of your heart called QT prolongation, which can cause irregular heartbeats and that may lead to death. You should not take CAPRELSA if you have had a condition called long QT syndrome since birth. Your healthcare provider should perform tests to check the levels of your blood potassium, calcium, magnesium, and thyroid-stimulating hormone (TSH), as well as the electrical activity of your heart with a test called an electrocardiogram (ECG). You should have these tests: Before starting CAPRELSA Regularly during CAPRELSA treatment: 2 to 4 weeks after starting CAPRELSA 8 to 12 weeks after starting CAPRELSA every 3 months thereafter if your healthcare provider changes your dose of CAPRELSA if you start taking medicine that causes QT prolongation as instructed by your healthcare provider Your healthcare provider may stop your CAPRELSA treatment for a while and restart you at a lower dose if you have QT prolongation. Call your healthcare provider right away if you feel faint, light-headed, or feel your heart beating irregularly during treatment with CAPRELSA. These may be symptoms related to QT prolongation. See " What are the possible side effects of CAPRELSA? " for more information about side effects.
From the patient leaflet: What should I avoid while taking CAPRELSA?Limit exposure to the sun. CAPRELSA can make your skin sensitive to the sun. During treatment with CAPRELSA and for at least 4 months after stopping treatment with CAPRELSA, use sun block and wear clothes that cover your skin, including your head, arms, and legs when you go outdoors. Use caution before driving or using machinery. Keep in mind CAPRELSA may make you feel tired, or cause blurred vision.
From the patient leaflet: How should I store CAPRELSA?Store CAPRELSA tablets at room temperature between 68°F and 77°F (20°C and 25°C). Safely throw away medicine that is out of date or that you no longer need. Ask your pharmacist how to safely throw away CAPRELSA tablets. Keep CAPRELSA and all medicines out of the reach of children.
Source: FDA drug label (CAPRELSA), Genzyme Corporation, effective April 23, 2026 (SPL set e5721cb8-4185-47b9-bbb3-1c587e558a03), via openFDA; the full label on DailyMed
Is there a generic for vandetanib (Caprelsa)?
No generic vandetanib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Caprelsa tablets, the last expiring on August 8, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 earliest approval on file
- 2028 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the vandetanib label say about other medicines?
The vandetanib label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 13 other medicines name vandetanib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | warnings and precautions | Avoid administration of CAPRELSA with anti-arrhythmic drugs (including but not limited to amiodarone, disopyramide, procainamide, sotalol, dofetilide) and other drugs that may prolong the QT interval (including but not limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone … |
| Chloroquine | warnings and precautions | Avoid administration of CAPRELSA with anti-arrhythmic drugs (including but not limited to amiodarone, disopyramide, procainamide, sotalol, dofetilide) and other drugs that may prolong the QT interval (including but not limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone … |
| Clarithromycin | warnings and precautions | Avoid administration of CAPRELSA with anti-arrhythmic drugs (including but not limited to amiodarone, disopyramide, procainamide, sotalol, dofetilide) and other drugs that may prolong the QT interval (including but not limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone … |
| Denosumab | warnings and precautions | Concomitant exposure to other risk factors, such as bisphosphonates, denosumab, dental disease or invasive dental procedures, may increase the risk of ONJ. |
| Digoxin | drug interactions | Effect of CAPRELSA on Digoxin CAPRELSA increased plasma concentrations of digoxin. |
| Disopyramide | warnings and precautions | Avoid administration of CAPRELSA with anti-arrhythmic drugs (including but not limited to amiodarone, disopyramide, procainamide, sotalol, dofetilide) and other drugs that may prolong the QT interval (including but not limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone … |
| Dofetilide | warnings and precautions | Avoid administration of CAPRELSA with anti-arrhythmic drugs (including but not limited to amiodarone, disopyramide, procainamide, sotalol, dofetilide) and other drugs that may prolong the QT interval (including but not limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone … |
| Granisetron | warnings and precautions | … drugs that may prolong the QT interval (including but not limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone, moxifloxacin, and pimozide) [see Drug Interactions (7.4) and Clinical Pharmacology (12.2) ]. |
| Haloperidol | warnings and precautions | … prolong the QT interval (including but not limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone, moxifloxacin, and pimozide) [see Drug Interactions (7.4) and Clinical Pharmacology (12.2) ]. |
| Metformin | drug interactions | Effect of CAPRELSA on OCT2 Transporter CAPRELSA increased plasma concentrations of metformin that is transported by the organic cation transporter type 2 (OCT2). |
| Methadone | warnings and precautions | … interval (including but not limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone, moxifloxacin, and pimozide) [see Drug Interactions (7.4) and Clinical Pharmacology (12.2) ]. |
| Moxifloxacin | warnings and precautions | … (including but not limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone, moxifloxacin, and pimozide) [see Drug Interactions (7.4) and Clinical Pharmacology (12.2) ]. |
| Pimozide | warnings and precautions | … limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone, moxifloxacin, and pimozide) [see Drug Interactions (7.4) and Clinical Pharmacology (12.2) ]. |
| Procainamide | warnings and precautions | Avoid administration of CAPRELSA with anti-arrhythmic drugs (including but not limited to amiodarone, disopyramide, procainamide, sotalol, dofetilide) and other drugs that may prolong the QT interval (including but not limited to chloroquine, clarithromycin, dolasetron, granisetron, haloperidol, methadone … |
Every other medicine the vandetanib label names
| Medicine named | Section | What the label says |
|---|---|---|
| Sotalol | warnings and precautions | Avoid administration of CAPRELSA with anti-arrhythmic drugs (including but not limited to amiodarone, disopyramide, procainamide, sotalol, dofetilide) and other drugs that may prolong the QT interval … |
Other labels that name vandetanib
Source: FDA drug label (CAPRELSA), Genzyme Corporation, effective April 23, 2026 (SPL set e5721cb8-4185-47b9-bbb3-1c587e558a03), via openFDA; the full label on DailyMed
What do FAERS reports show for vandetanib?
The FDA Adverse Event Reporting System holds 1,794 reports that list vandetanib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 161 are coded as a death and 522 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Vandetanib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other