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Panobinostat Side Effects

In Summary

Commonly reported side effects of panobinostat include: severe diarrhea, pneumonia, severe infection, severe neutropenia, cardiac arrhythmia, abnormal t waves on ecg, depression of st segment on ecg, diarrhea, neutropenia, and thrombocytopenia. Other side effects include: sepsis, and hemorrhage. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to panobinostat: oral capsule

Along with its needed effects, panobinostat 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 panobinostat:

More Common

  • Abdominal or stomach pain or tenderness
  • black, tarry stools
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • clay colored stools
  • confusion
  • cough or sore throat
  • dark or bloody urine
  • decreased appetite
  • decreased frequency or amount of urine
  • dizziness, faintness, or lightheadedness especially when getting up suddenly from a lying or sitting position
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever, chills, or sweating
  • headache
  • increased thirst
  • itching or skin rash
  • loss of appetite
  • lower back or side pain
  • muscle spasms or twitching
  • nausea or vomiting
  • nervousness
  • painful or difficult urination
  • pinpoint red spots on the skin
  • pounding in the ears
  • rapid breathing
  • seizures
  • severe diarrhea
  • slow or fast heartbeat
  • swelling of the face, fingers, feet, or lower legs
  • tingling of the hands or feet
  • trouble breathing
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • yellow eyes or skin

Less Common

Some side effects of panobinostat 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 or passing gas
  • change or loss in taste
  • depressed mood
  • dry mouth
  • hair loss
  • heartburn or indigestion
  • hoarseness or husky voice
  • fatigue or feeling lethargic
  • redness of the skin

For Healthcare Professionals

Applies to panobinostat: oral capsule

Gastrointestinal

Very common (10% or more): Diarrhea (68%), nausea (36%), vomiting (26%)

Common (1% to 10%): Abdominal pain, dyspepsia, gastritis, cheilitis, abdominal distension, dry mouth, flatulence, colitis, gastrointestinal pain

Cardiovascular

Very common (10% or more): T-wave abnormalities (40%), ST-segment depression (22%), arrhythmia (12%)

Common (1% to 10%): Palpitations, hypotension, hypertension, orthostatic hypotension

Uncommon (0.1% to 1%): Cardiac ischemic events[Ref]

Hematologic

Very common (10% or more): Thrombocytopenia (97%), lymphopenia (82%), leukopenia (81%), neutropenia (75%), anemia (62%)

Common (1% to 10%): Grade 3/4 hemorrhage

Immunologic

Very common (10% or more): Severe infections (31%)

Common (1% to 10%): Hepatitis B

Hepatic

Common (1% to 10%): Increased blood alkaline phosphatase

Frequency not reported: Hepatic dysfunction (primarily aminotransferase and total bilirubin elevations)

Metabolic

Very common (10% or more): Hypocalcemia (67%), hypoalbuminemia (63%), hypophosphatemia (63%), hypokalemia (52%), hyponatremia (49%), hyperphosphatemia (29%), decreased appetite (28%), hypermagnesemia (27%), hyperbilirubinemia (21%), decreased weight (12%)

Common (1% to 10%): Hyperglycemia, dehydration, fluid retention, hypomagnesemia

Dermatologic

Common (1% to 10%): Skin lesions, rash, erythema

Endocrine

Common (1% to 10%): Hypothyroidism

Genitourinary

Common (1% to 10%): Urinary incontinence, hyperuricemia

Musculoskeletal

Common (1% to 10%): Joint swelling

Nervous system

Common (1% to 10%): Dizziness, headache, syncope, tremor, dysgeusia

Other

Very common (10% or more): Fatigue (60%), peripheral edema (29%), pyrexia (26%)

Common (1% to 10%): Chills

Psychiatric

Common (1% to 10%): Insomnia

Renal

Very common (10% or more): Increased blood creatinine (41%)

Common (1% to 10%): Renal failure, increased blood urea, decreased glomerular filtration rate

Respiratory

Common (1% to 10%): Cough, dyspnea, respiratory failure, rales, wheezing

References

1. "Product Information. Farydak (panobinostat)." Novartis Pharmaceuticals, East Hanover, NJ.

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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