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Vandetanib Side Effects

In Summary

Commonly reported side effects of vandetanib include: exfoliative dermatitis, hypertensive crisis, upper respiratory tract infection, abdominal distress, abdominal pain, acne vulgaris, bullous dermatitis, colitis, decreased serum calcium, decreased serum glucose, depression, dermatitis, diarrhea, dyspepsia, eczema, erythematous rash, headache, hypertension, hypocalcemia, increased serum alanine aminotransferase, increased serum creatinine, lower abdominal pain, macular eruption, maculopapular rash, nausea, papular rash, prolonged qt interval on ecg, proteinuria, pruritic rash, pruritus, skin rash, upper abdominal pain, skin photosensitivity, vomiting, erythema, and xeroderma. Other side effects include: hypothyroidism, and xerostomia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to vandetanib: oral tablet

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

  • Abdominal or stomach cramps or pain
  • bleeding gums
  • blurred vision
  • body aches or pain
  • chest pain
  • cloudy urine
  • confusion
  • convulsions
  • cough
  • coughing up blood
  • difficulty with breathing or swallowing
  • dizziness
  • ear congestion
  • fainting
  • fever or chills
  • headache
  • increased menstrual flow or vaginal bleeding
  • irregular heartbeat recurrent
  • loss of voice
  • muscle cramps in the hands, arms, feet, legs, or face
  • nervousness
  • nosebleeds
  • numbness and tingling around the mouth, fingertips, or feet
  • paralysis
  • pounding in the ears
  • prolonged bleeding from cuts
  • red or black, tarry stools
  • red or dark brown urine
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tenderness
  • tightness in the chest
  • tremor
  • troubled breathing
  • unusual tiredness or weakness (severe)
  • watery or bloody diarrhea

Less Common

  • Blue lips, fingernails, or skin
  • chest pain or discomfort
  • dilated neck veins
  • extreme fatigue
  • foreign substance into the lungs
  • infection from breathing
  • irregular breathing
  • irregular heartbeat
  • irregular, fast or slow, or shallow breathing
  • lightheadedness
  • no breathing
  • swelling of the face, fingers, feet, or lower legs
  • weight gain

Rare

  • Bloating
  • constipation
  • darkened urine
  • decreased urine output
  • indigestion
  • loss of appetite
  • nausea
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • yellow eyes or skin

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

  • Acid or sour stomach
  • belching
  • blemishes on the skin
  • blindness
  • blistering, crusting, irritation, itching, or reddening of the skin
  • change in taste
  • cracked, dry, or scaly skin
  • cracks in the skin
  • decreased appetite
  • decreased vision
  • decreased weight
  • depression
  • discoloration of the fingernails or toenails
  • dry mouth
  • dry skin
  • hair loss or thinning of the hair
  • heartburn
  • increased sensitivity of the skin to sunlight
  • itching skin
  • lack or loss of strength
  • loosening of the fingernails
  • loss of heat from the body
  • loss of taste
  • muscle aches or spasms
  • pimples
  • rash with flat lesions or small raised lesions on the skin
  • red, swollen skin
  • redness or other discoloration of the skin
  • redness or soreness around the fingernails
  • severe sunburn
  • stomach discomfort or upset
  • swelling
  • trouble sleeping

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

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]

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]

Dermatologic

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]

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]

Gastrointestinal

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

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]

Genitourinary

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

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

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

Hematologic

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

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

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

Hepatic

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

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

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

Metabolic

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]

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

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

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

Common (1% to 10%): Pyrexia[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, Wilmington, DE.

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.

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