Applies to palonosetron: intravenous solution.

Serious side effects of Palonosetron

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

Other side effects of Palonosetron

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.

General

The most commonly reported side effects included headache, constipation, diarrhea, and dizziness.^[Ref]

Cardiovascular

Common (1% to 10%): Bradycardia/sinus bradycardia, electrocardiogram QTc prolongation, hypotension, nonsustained tachycardia/tachycardia

Uncommon (0.1% to 1%): Atrioventricular (AV) block first degree, AV block second degree, conduction disorder, extrasystoles, hypertension, myocardial ischemia, sinus arrhythmia, sinus tachycardia, supraventricular extrasystoles, vein discoloration, vein distended

Frequency not reported: Arrhythmia, blood pressure decreased, ECG T wave amplitude decreased, generalized edema, hot flash, ventricular extrasystoles

Postmarketing reports: Shock^[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea, flatulence

Uncommon (0.1% to 1%): Abdominal pain, abdominal pain upper, dry mouth, dyspepsia, nausea

Frequency not reported: Intestinal hypomobility, salivary hypersecretion^[Ref]

Other

Common (1% to 10%): Asthenia, weakness

Uncommon (0.1% to 1%): Fatigue, feeling hot, motion sickness, pain, pyrexia, tinnitus

Frequency not reported: Chills, fever^[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache

Uncommon (0.1% to 1%): Dyskinesia, hypersomnia, paresthesia, peripheral sensory neuropathy, somnolence^[Ref]

Hepatic

Common (1% to 10%): Increased ALT, increased AST

Uncommon (0.1% to 1%): Blood bilirubin increased, elevated transaminases, hyperbilirubinemia

Frequency not reported: Hepatic enzymes increased, transient, asymptomatic increases in AST and/or ALT and bilirubin^[Ref]

Metabolic

Common (1% to 10%): Hyperkalemia

Uncommon (0.1% to 1%): Anorexia, appetite decreased, hyperglycemia, hypocalcemia, hypokalemia, metabolic disorders

Frequency not reported: Electrolyte fluctuations, metabolic acidosis^[Ref]

Dermatologic

Common (1% to 10%): Pruritus

Uncommon (0.1% to 1%): Allergic dermatitis, pruritic rash, skin disorder, urticaria^[Ref]

Psychiatric

Common (1% to 10%): Anxiety

Uncommon (0.1% to 1%): Euphoric mood, insomnia^[Ref]

Genitourinary

Common (1% to 10%): Urinary retention

Uncommon (0.1% to 1%): Glycosuria^[Ref]

Respiratory

Uncommon (0.1% to 1%): Cough, dyspnea, epistaxis, hiccups

Frequency not reported: Hypoventilation, laryngospasm^[Ref]

Ocular

Uncommon (0.1% to 1%): Amblyopia, eye irritation, eye swelling^[Ref]

Local

Uncommon (0.1% to 1%): Infusion site pain, infusion site reaction

Very rare (less than 0.01%): Injection site reaction

Frequency not reported: Injection site burning, injection site discomfort, injection site induration, injection site pain^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Arthralgia, myalgia^[Ref]

Hypersensitivity

Very rare (less than 0.01%): Hypersensitivity reactions

Frequency not reported: Anaphylactic shock, anaphylaxis^[Ref]

Hematologic

Frequency not reported: Platelet count decreased^[Ref]

Immunologic

Uncommon (0.1% to 1%): Influenza-like illness

Frequency not reported: Flu-like syndrome^[Ref]