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Palonosetron Side Effects

For the Consumer

Applies to palonosetron: intravenous solution

Along with its needed effects, palonosetron 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 or nurse immediately if any of the following side effects occur while taking palonosetron:

Less common
  • Blurred vision
  • chest pain or discomfort
  • confusion
  • difficult breathing
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • fainting
  • fever
  • irregular heartbeats that continue
  • sweating
  • unusual tiredness or weakness
Rare
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • extra heartbeats
  • nervousness
  • pain in the shoulders, arms, jaw, or neck
  • pounding in the ears
  • slow or fast heartbeat
Incidence not known
  • Agitation
  • diarrhea
  • overactive reflexes
  • poor coordination
  • restlessness
  • shivering
  • talking or acting with excitement you cannot control
  • trembling or shaking
  • twitching

Get emergency help immediately if any of the following symptoms of overdose occur while taking palonosetron:

Symptoms of overdose
  • Bluish color of the fingernails, lips, skin, palms, or nail beds
  • collapse
  • gasping to breathe
  • paleness of the skin
  • seizures

Some side effects of palonosetron 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
  • Difficulty having a bowel movement (stool)
  • headache
Less common
  • Acid or sour stomach
  • belching
  • bloated or full feeling
  • blood in the urine
  • bloody or black, tarry stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in vision
  • chills
  • continuing ringing or buzzing
  • cough
  • decrease in frequency of urination
  • decrease in urine volume
  • deep breathing
  • difficulty in passing urine
  • drowsiness
  • dry mouth
  • excess air or gas in the stomach or intestines
  • excessive sleeping
  • eye irritation
  • fear
  • feeling happy
  • feeling of warmth
  • flushed dry skin
  • fruit-like breath odor
  • general feeling of discomfort or illness
  • hearing loss
  • heartburn
  • hiccups
  • impaired vision
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • joint pain
  • large, flat, blue or purplish patches in the skin
  • loss of appetite
  • muscle aches and pains
  • muscle tremors
  • numbness or tingling in the hands, feet, or lips
  • painful knees and ankles
  • painful urination
  • passing gas
  • raised red swellings on the skin, the buttocks, legs or ankles
  • rash
  • red, sore eyes
  • redness of the face, neck, arms, and occasionally, upper chest
  • runny nose
  • sore throat
  • stomach discomfort, upset, or pain
  • sugar in the urine
  • swelling or protruding veins
  • trouble sleeping
  • unexplained noise in the ears
  • unexplained weight loss
  • unusually deep sleep
  • unusually long duration of sleep
  • vein discoloration
  • weakness or heaviness of the legs

For Healthcare Professionals

Applies to palonosetron: intravenous solution, oral capsule

Cardiovascular

Common (1% to 10%): Bradycardia, hypotension, nonsustained tachycardia
Uncommon (0.1% to 1%): Hypertension, myocardial ischemia, extrasystoles, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles, QT prolongation[Ref]

Dermatologic

Uncommon (0.1% to 1%): Allergic dermatitis, rash[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea
Uncommon (0.1% to 1%): Appetite decrease, dyspepsia, abdominal pain, dry mouth, hiccups, flatulence[Ref]

Hepatic

Uncommon (0.1% to 1%): Transient, asymptomatic increases in AST and/or ALT and bilirubin; increased transaminases[Ref]

Metabolic

Common (1% to 10%): Hyperkalemia
Uncommon (0.1% to 1%): Electrolyte fluctuations, hyperglycemia, metabolic acidosis, glycosuria[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary retention[Ref]

Psychiatric

Common (1% to 10%): Anxiety
Uncommon (0.1% to 1%): Euphoric mood[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Fatigue, fever, hot flash, insomnia, somnolence, hypersomnia, paresthesia[Ref]

Musculoskeletal

Common (1% to 10%): Weakness
Uncommon (0.1% to 1%): Arthralgia[Ref]

Ocular

Uncommon (0.1% to 1%): Eye irritation, amblyopia[Ref]

Local

Very rare (less than 0.01%): Injection site reactions (burning, induration, discomfort, and pain)[Ref]

Other

Uncommon (0.1% to 1%): Motion sickness, tinnitus, vein discoloration, vein distention, influenza-like syndrome[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Aloxi (palonosetron)." MGI Pharma Inc, Minnetonka, MN.

4. Eisenberg P, Figueroa-Vadillo J, Zamora R, et al. "Improved prevention of moderately emetogenic chemotherapy-induced nausea and vomiting with palonosetron, a pharmacologically novel 5-HT3 receptor antagonist." Cancer 98 (2003): 2473-82

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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