Zolinza Side Effects

Generic name: vorinostat

Note: This document contains side effect information about vorinostat. Some of the dosage forms listed on this page may not apply to the brand name Zolinza.

Some side effects of Zolinza may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to vorinostat: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking vorinostat (the active ingredient contained in Zolinza) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using vorinostat and call your doctor at once if you have a serious side effect such as:

• chest pain, sudden cough, wheezing, rapid breathing;

• pain, swelling, warmth, or redness in one or both legs;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• severe or ongoing vomiting or diarrhea;

• bloody, black, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• feeling very thirsty or hot, being unable to urinate, heavy sweating or hot and dry skin; or

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision).

Less serious side effects of vorinostat may include:

• nausea, constipation, diarrhea;

• loss of appetite, weight loss;

• headache, tired feeling;

• itching, chills;

• dry mouth;

• hair loss;

• altered sense of taste;

• muscle spasms; or

• cold symptoms such as stuffy nose, sneezing, cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to vorinostat: oral capsule

General

General side effects including fatigue (52.3%), decreased weight (20.9%), chills (16.3%), dizziness (15.1%), and pyrexia (10.5%) have been reported. A case of syncope has also been reported.

Gastrointestinal

Gastrointesinal side effects including diarrhea (52.3%), nausea (40.7%), dysgeusia (27.9%), anorexia (24.4%), dry mouth (16.3%), vomiting (15.1%), constipation (15.1%), and decreased appetite (14%) have been reported. Cases of cholecystitis and gastrointestinal hemorrhage have also been reported.

Hematologic

Hematologic side effects including thrombocytopenia (25.6%), increased blood creatinine (16.3%), and anemia (up to 14.0%) have been reported.

Musculoskeletal

Musculoskeletal side effects including muscle spasms (19.8%) have been reported. A case of spinal cord injury has also been reported.

Dermatologic

Dermatologic side effects including alopecia (18.6%) and pruritis (11.6%) have been reported. A case of exfoliative dermatitis has also been reported.

Cardiovascular

Cardiovascular side effects including peripheral edema (12.8%) have been reported. Cases of deep vein thrombosis, myocardial infarction, and ischemic stroke have also been reported.

Nervous system

Nervous system side effects including headache (11.6%) have been reported.

Respiratory

Respiratory side effects including upper respiratory infection (10.5%), cough (10.5%), and pulmonary embolism (4.7%) have been reported. A case of lobar pneumonia has also been reported.

Oncologic

Oncologic side effects including squamous cell carcinoma (3.5%) have been reported. A case of T-cell lymphoma has also been reported.

Other

Other side effects have been reported including a case of a death from unknown causes. Cases of enterococcal infection, infection, sepsis, and streptococcal bacteremia have also been reported.

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