Palonosetron Side Effects

It is possible that some side effects of palonosetron may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to palonosetron: intravenous solution

As well as its needed effects, palonosetron may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking palonosetron, check with your doctor or nurse immediately:

Less common
  • Blurred vision
  • chest pain or discomfort
  • confusion
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • fainting
  • irregular heartbeats that continue
  • shortness of breath
  • sweating
  • unusual tiredness or weakness
Rare
  • Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at injection site
  • extra heartbeats
  • nervousness
  • pain in the shoulders, arms, jaw or neck
  • pounding in the ears
  • slow or fast heartbeat

If any of the following symptoms of overdose occur while taking palonosetron, get emergency help immediately:

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

Some palonosetron side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Difficulty having a bowel movement (stool)
  • headache
Less common
  • Abdominal pain
  • acid or sour stomach
  • belching
  • bloated full feeling
  • blood in 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
  • diarrhea
  • difficult breathing
  • difficulty in passing urine
  • drowsiness
  • dry mouth
  • excess air or gas in stomach or intestines
  • excessive sleeping
  • eye irritation
  • fear
  • feeling happy
  • feeling of warmth
  • fever
  • 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 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
  • restlessness
  • runny nose
  • shivering
  • sore throat
  • stomach discomfort, upset, or pain
  • sugar in the urine
  • swelling or protruding veins
  • trembling
  • troubled breathing
  • trouble sleeping
  • unexplained noise in ears
  • unexplained weight loss
  • unusually deep sleep
  • unusually long duration of sleep
  • vein discoloration
  • weakness or heaviness of legs

For Healthcare Professionals

Applies to palonosetron: intravenous solution, oral capsule

Cardiovascular

Cardiovascular side effects have been reported rarely. Bradycardia, hypotension, and nonsustained tachycardia have been reported in approximately 1% of patients in clinical trials. Hypertension, myocardial ischemia, extrasystoles, sinus tachycardia, sinus arrhythmia, supraventricular extrasystoles, and QT prolongation have been reported in less than 1% of patients. In many cases, causality was unclear.

Dermatologic

Dermatological side effects including allergic dermatitis (less than 1%) and rash (less than 1%) have been rarely reported.

Gastrointestinal

Gastrointestinal side effects have included constipation (2% to 5% or greater ) and diarrhea (1%). Appetite decrease, dyspepsia, abdominal pain, dry mouth, hiccups, and flatulence have been reported by less that 1% of patients in clinical trials.

General

General side effects have included reports of headache (2% to 9% or greater) and weakness (1%). Fatigue, fever, hot flash, and flu-like syndrome have been reported by less than 1% of patients in clinical trials.

Hepatic

Hepatic side effects occurred mainly in patients receiving highly emetogenic chemotherapy.

Hepatic side effects including transient, asymptomatic increases in AST and/or ALT and bilirubin have been reported in less than 1% of patients.

Metabolic

Metabolic side effects have included hyperkalemia (1%), electrolyte fluctuations, hyperglycemia, metabolic acidosis, and glycosuria.

Genitourinary

Genitourinary side effects have included urinary retention (less than 1%).

Psychiatric

Psychiatric side effects have included anxiety (1% to 2% or greater), anorexia (less than 1%), and euphoric mood (less than 1%).

Nervous system

Nervous system side effects including headache (2% to 9% or greater) and dizziness (1% to 2% or greater) have been reported. Insomnia, somnolence, hypersomnia, and paresthesia have been reported in less than 1% of patients.

Musculoskeletal

Musculoskeletal side effects have rarely included arthralgia (less than 1%).

Ocular

Ocular side effects including eye irritation and amblyopia have been reported in less than 1% of patients.

Local

Local side effects have included very rare cases of injection site reactions (burning, induration, discomfort, and pain) during postmarketing experience.

Other

Other side effects including fatigue and asthenia have been reported in greater than or equal to 2% of patients. Motion sickness, tinnitus, vein discoloration, and vein distention have been reported in less than 1% of patients.

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