Caprelsa Side Effects
Generic Name: vandetanib
Note: This page contains information about the side effects of vandetanib. Some of the dosage forms included on this document may not apply to the brand name Caprelsa.
Not all side effects for Caprelsa may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to vandetanib: oral tablet
In addition to its needed effects, some unwanted effects may be caused by vandetanib (the active ingredient contained in Caprelsa). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking vandetanib:More common
- Abdominal or stomach cramps or pain
- bleeding gums
- blurred vision
- body aches or pain
- chest pain
- cloudy urine
- coughing up blood
- difficulty with breathing or swallowing
- ear congestion
- fever or chills
- increased menstrual flow or vaginal bleeding
- irregular heartbeat recurrent
- loss of voice
- muscle cramps in the hands, arms, feet, legs, or face
- numbness and tingling around the mouth, fingertips, or feet
- pounding in the ears
- prolonged bleeding from cuts
- red or black, tarry stools
- red or dark brown urine
- slow or fast heartbeat
- sore throat
- stuffy or runny nose
- tightness in the chest
- troubled breathing
- unusual tiredness or weakness (severe)
- watery or bloody diarrhea
- 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
- no breathing
- swelling of the face, fingers, feet, or lower legs
- weight gain
- darkened urine
- decreased urine output
- loss of appetite
- pains in the stomach, side, or abdomen, possibly radiating to the back
- yellow eyes or skin
Some of the side effects that can occur with vandetanib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- Acid or sour stomach
- blemishes on the skin
- 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
- discoloration of the fingernails or toenails
- dry mouth
- dry skin
- hair loss or thinning of the hair
- 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
- 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
- trouble sleeping
For Healthcare Professionals
Applies to vandetanib: oral tablet
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%.
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 (the active ingredient contained in Caprelsa) 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.
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
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
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.
CTCAE grade 3 to 4 diarrhea/colitis, nausea, abdominal pain, and vomiting were reported in 11%, 1%, 3%, and 1%, respectively.
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
Very common (10% or more): Proteinuria (10%)
Common (1% to 10%): Urinary tract infection
Uncommon (0.1% to 1%): Calculus ureteric
Very common (10% or more): Bleeding (14%); neutropenia (10%)
Common (1% to 10%): Thrombocytopenia (9%)
Less than 1% of patients experienced CTCAE grade 3 to 4 neutropenia. Bleeding events were grade 1 to 2 events.
Very common (10% or more): ALT increased (51%)
Uncommon (0.1% to 1%): Cholecystitis, cholelithiasis
An ALT increase classified as CTCAE grade 3 to 4 was experienced in 2% of patients.
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
CTCAE grade 3 to 4 hypocalcemia, decreased appetite, and hypomagnesemia occurred in 6%, 4%, and less than 1 % of patients, respectively.
Common (1% to 10%): Muscle spasms
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
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.
Very common (10% or more): Corneal abnormalities (13%)
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Glaucoma
CTCAE grade 3 to 4 fatigue was reported in 6% of patients.
Very common (10% or more): Fatigue (24%); asthenia (15%)
Common (1% to 10%): Pyrexia
CTCAE grade 3 to 4 depression was reported in 2% of patients.
Very common (10% or more): Insomnia (13%); depression (10%)
Common (1% to 10%): Anxiety
Uncommon (0.1% to 1%): Bipolar disorder
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
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
Very common (10% or more): Thyroid stimulating hormone (TSH) elevation (18.6%)
Common (1% to 10%): Hypothyroidism
More about Caprelsa (vandetanib)
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