Skip to main content

Vandetanib Side Effects

Medically reviewed by Drugs.com. Last updated on Jul 16, 2023.

Applies to vandetanib: oral tablet.

Warning

Oral route (Tablet)

Vandetanib can prolong the QT interval, and torsades de pointes and sudden death have been reported with its use. Do not use in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome; electrolyte depletion must be corrected prior to starting vandetanib and should be periodically monitored. Avoid drugs that are known to prolong the QT interval. Vandetanib is only available through a restricted distribution program (Vandetanib REMS).

Serious side effects of Vandetanib

Along with its needed effects, vandetanib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking vandetanib:

More common

Less common

Rare

Other side effects of Vandetanib

Some side effects of vandetanib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to vandetanib: oral tablet.

General

The most commonly reported adverse effects in decreasing order of frequency included diarrhea/colitis, rash, acneiform dermatitis, hypertension, nausea, headache, upper respiratory tract infections, decreased appetite, and abdominal pain.

During clinical trials, treatment discontinuation due to adverse reactions occurred in 21% of patients. Events leading to discontinuation included asthenia, rash, diarrhea, fatigue, pyrexia, elevated creatinine, QT prolongation, and hypertension. Dose interruption occurred in 47% of patients and dose reduction in 36%.[Ref]

Cardiovascular

Very common (10% or more): Hypertension/hypertensive crisis/accelerated hypertension (33%); ECG QT prolonged (14%)

Uncommon (0.1% to 1%): Heart failure, arrhythmia, atrial fibrillation, bradycardia, pericarditis, chest pain, cardiac arrest

Frequency not reported: Torsades de pointes; ventricular tachycardia[Ref]

Common terminology criteria for adverse events (CTCAE) grade 3 to 4 hypertension/hypertensive crisis/accelerated hypertension was reported in 9% of patients.

CTCAE grade 3 to 4 QT prolongation was reported in 8% of patients. Among patients who experienced QT prolongation, 69% experienced a QT interval Fridericia (QTcF) greater than 450 milliseconds (msec) with 7% having reported a QTcF greater than 500 msec. In a pharmacodynamics study in patients with medullary thyroid cancer receiving vandetanib 300 mg orally once daily, mean change in QTcF was 35 msec and mean change in QTcF remained above 30 msec for the duration of the trial (up to 2 years). A change in QTcF greater than 60 msec was reported in 36% of patients experience and 4.3% of patients had a QTcF greater than 500 msec.[Ref]

Dermatologic

Types of rash reported included rash, rash (erythematous, generalized, macular, maculopapular, popular, pruritic, and exfoliative), dermatitis, bullous dermatitis, generalized erythema, and eczema. CTCAE grade 3 to 4 rash, dermatitis/acneiform/acne, photosensitivity reaction, and pruritus were reported in 5%, 1%, 2%, and 1% of patients, respectively.

Nail abnormalities reported included nail disorder, nail bed inflammation, nail bed tenderness, paronychia, nail bed infection, and nail infection.[Ref]

Very common (10% or more): Rash (53%); dermatitis acneiform/acne (35%); dry skin (15%); photosensitivity reaction (13%); pruritus (11%)

Common (1% to 10%): Nail abnormalities; alopecia

Uncommon (0.1% to 1%): Skin ulcer

Frequency not reported: Stevens-Johnson syndrome, erythema multiforme[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea/colitis (57%); nausea (33%); abdominal pain (21%); vomiting (15%); dyspepsia (11%);

Common (1% to 10%): Dry mouth

Uncommon (0.1% to 1%): Pancreatitis, intestinal perforation, dysphagia, gastrointestinal hemorrhage, colitis, gastritis, ileus, peritonitis[Ref]

CTCAE grade 3 to 4 diarrhea/colitis, nausea, abdominal pain, and vomiting were reported in 11%, 1%, 3%, and 1%, respectively.[Ref]

Genitourinary

Very common (10% or more): Proteinuria (10%)

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Calculus ureteric[Ref]

Hematologic

Less than 1% of patients experienced CTCAE grade 3 to 4 neutropenia. Bleeding events were grade 1 to 2 events.[Ref]

Very common (10% or more): Bleeding (14%); neutropenia (10%)

Common (1% to 10%): Thrombocytopenia (9%)[Ref]

Hepatic

An ALT increase classified as CTCAE grade 3 to 4 was experienced in 2% of patients.[Ref]

Very common (10% or more): ALT increased (51%)

Uncommon (0.1% to 1%): Cholecystitis, cholelithiasis[Ref]

Metabolic

CTCAE grade 3 to 4 hypocalcemia, decreased appetite, and hypomagnesemia occurred in 6%, 4%, and less than 1 % of patients, respectively.[Ref]

Very common (10% or more): Hypocalcemia (57%); hypoglycemia (24%); decreased appetite (21%)

Common (1% to 10%): Hypomagnesemia, hypokalemia, hypercalcemia, hyperglycemia, dehydration, hyponatremia, weight loss

Uncommon (0.1% to 1%): Hypokalemia[Ref]

Musculoskeletal

Common (1% to 10%): Muscle spasms[Ref]

Nervous system

Very common (10% or more): Headache (26%); paresthesia, dizziness

Common (1% to 10%): Dysgeusia, tremor, lethargy, loss of consciousness, balance disorder

Uncommon (0.1% to 1%): Convulsion, clonus, brain edema

Frequency not reported: Reversible posterior leukoencephalopathy syndrome[Ref]

Ocular

Ocular abnormalities included corneal edema, corneal opacity, corneal dystrophy, corneal pigmentation, keratopathy, arcus lipoides, corneal deposits, acquired corneal dystrophy. Slit lamp examination of vandetanib-treated patients revealed vortex keratopathy.[Ref]

Very common (10% or more): Corneal abnormalities (13%)

Common (1% to 10%): Blurred vision

Uncommon (0.1% to 1%): Glaucoma[Ref]

Other

Very common (10% or more): Fatigue (24%); asthenia (15%)

Common (1% to 10%): Pyrexia[Ref]

CTCAE grade 3 to 4 fatigue was reported in 6% of patients.[Ref]

Psychiatric

CTCAE grade 3 to 4 depression was reported in 2% of patients.[Ref]

Very common (10% or more): Insomnia (13%); depression (10%)

Common (1% to 10%): Anxiety

Uncommon (0.1% to 1%): Bipolar disorder[Ref]

Renal

Very common (10% or more): Increased creatinine (16%)

Common (1% to 10%): Pyelonephritis

Uncommon (0.1% to 1%): Nephrolithiasis, anuria, renal colic, renal failure, tubulointerstitial nephritis

Respiratory

Very common (10% or more): Upper respiratory tract infections (23%); cough (11%)

Common (1% to 10%): Pneumonia, epistaxis

Uncommon (0.1% to 1%): Pneumonitis, hemoptysis, bronchospasm, chylothorax, dyspnea, respiratory arrest, respiratory failure[Ref]

Endocrine

Very common (10% or more): Thyroid stimulating hormone (TSH) elevation (18.6%)

Common (1% to 10%): Hypothyroidism

References

1. Product Information. Vandetanib (vandetanib). Astra-Zeneca Pharmaceuticals. 2011.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer