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

Summary

More frequent side effects include: dizziness. Continue reading for a comprehensive list of adverse effects.

Applies to dolasetron: oral tablet. Other dosage forms:

• intravenous solution

Serious side effects of Anzemet

Along with its needed effects, dolasetron (the active ingredient contained in Anzemet) 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 dolasetron:

More common

• Chest pain or discomfort
• lightheadedness, dizziness, or fainting
• slow or irregular heartbeat
• unusual tiredness or weakness

Less common

• Chills
• decrease in the amount of urine
• fast, pounding, or irregular heartbeat or pulse
• fever

Rare

• Agitation
• black, tarry stools
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• blurred vision
• burning while urinating
• changes in skin color
• confusion
• cough
• delirium
• depression
• diarrhea
• difficult or labored breathing
• difficult or painful urination
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• feeling of warmth
• feeling uncoordinated
• frequent urination
• hallucinations
• headache
• hives or welts, itching, or skin rash
• increased volume of pale, dilute urine
• irritability
• lethargy
• muscle twitching
• nausea
• noisy breathing
• numbness and tingling of the face, fingers, or toes
• pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
• pain, tenderness, or swelling of the foot or leg
• pale skin
• pale, bluish-colored, or cold hands or feet
• pinpoint red or purple spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red skin
• rigid muscles
• seizures
• sweating
• swelling of the face, ankles, or hands
• tightness in the chest
• tingling of the hands or feet
• tremor
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual weight gain or loss
• vomiting
• weak or absent pulses in the legs

Other side effects of Anzemet

Some side effects of dolasetron 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:

Less common

• Belching
• heartburn
• indigestion
• pain
• stomach discomfort, upset, or pain

Rare

• Abnormal dreams
• bad, unusual, or unpleasant (after) taste
• bloating
• bloody nose
• change in taste
• changes in vision
• continuing ringing or buzzing or other unexplained noise in the ears
• darkened urine
• difficulty having a bowel movement (stool)
• difficulty seeing at night
• difficulty with moving
• feeling of constant movement of self or surroundings
• feeling of unreality
• hearing loss
• increased sensitivity of the eyes to sunlight
• increased sweating
• joint pain
• loss of appetite
• muscle aching or cramping
• muscle pain or stiffness
• pain or burning sensation at the injection site
• pains in the stomach, side, or abdomen, possibly radiating to the back
• redness of the face, neck, arms, and occasionally, upper chest
• sensation of spinning
• sense of detachment from self or body
• shakiness and unsteady walk
• shakiness in the legs, arms, hands, or feet
• swollen joints
• unsteadiness, trembling, or other problems with muscle control or coordination
• weight loss
• yellow eyes or skin

For Healthcare Professionals

Applies to dolasetron: intravenous solution, oral tablet.

General

The most common side effects include headache, constipation, sleep disorders, and dizziness.^[Ref]

Nervous system

Loss of consciousness may occur immediately/closely after an IV bolus in patients receiving treatment for prophylaxis of chemotherapy induced nausea and vomiting.

Headache and dizziness occurred more frequently at higher doses.^[Ref]

Very common (10% or more): Headache (up to 41.1%), dizziness (up to 12.5%), drowsiness (up to 10.5%)

Rare (0.01% to 0.1%): Seizure, syncope

Frequency not reported: Taste perversion, vertigo, paresthesia, tremor, ataxia

Postmarketing reports: Loss of consciousness^[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 28.6%), dyspepsia (up to 12.8%), diarrhea (up to 11.1%), abdominal pain (up to 10.2%)

Rare (0.01% to 0.1%): Intestinal obstruction, pancreatitis^[Ref]

Psychiatric

Very common (10% or more): Sleep disorder (up to 12.8%)

Frequency not reported: Agitation, depersonalization, confusion, anxiety, abnormal dreaming^[Ref]

Other

Very common (10% or more): Fatigue (up to 12.2%)

Common (1% to 10%): Pain, fever, chills/shivering

Frequency not reported: Tinnitus

Postmarketing reports: Facial edema^[Ref]

Cardiovascular

Severe hypotension and bradycardia occurred immediately/closely after an IV bolus in patients receiving treatment for prophylaxis of chemotherapy induced nausea and vomiting.

Wide complex tachycardia, ventricular tachycardia, and ventricular fibrillation/cardiac arrest were rarely reported after IV administration.^[Ref]

Common (1% to 10%): Bradycardia (mostly sinus), hypotension, tachycardia (mostly sinus)

Uncommon (0.1% to 1%): Chest pain, orthostatic hypotension, hypertension

Rare (0.01% to 0.1%): Myocardial ischemia, edema

Frequency not reported: T wave change, ST-T wave change, sinus arrhythmia, extrasystole (atrial/ventricular premature contractions), poor R wave progression, left and right bundle branch block, nodal arrhythmias, U wave change, atrial flutter/fibrillation, peripheral edema, Mobitz I AV block, palpitations, peripheral ischemia, thrombophlebitis/phlebitis

Postmarketing reports: Severe hypotension, wide complex tachycardia, ventricular tachycardia, ventricular fibrillation/cardiac arrest, shock^[Ref]

Hepatic

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

Rare (0.01% to 0.1%): Jaundice

Frequency not reported: Hyperbilirubinemia, increased GGT^[Ref]

Increased serum transaminases occurred more frequently in patients treated during IV chemotherapy/radiotherapy than those treated during postoperative therapy/IV surgery; however, the increases did not appear to be related to dose/duration of therapy, and were not associated with symptomatic hepatic disease.^[Ref]

Respiratory

Respiratory side effects have rarely included dyspnea and bronchospasm.^[Ref]

Hematologic

Frequency not reported: Prothrombin time prolonged, partial thromboplastin time (PTT) increased, anemia, purpura/hematoma, thrombocytopenia^[Ref]

Genitourinary

Frequency not reported: Hematuria, dysuria, urinary retention, polyuria^[Ref]

Dermatologic

Frequency not reported: Increased sweating, flushing, rash

Postmarketing reports: Urticaria^[Ref]

Musculoskeletal

Frequency not reported: Myalgia, arthralgia, twitching^[Ref]

Metabolic

Frequency not reported: Anorexia, increased alkaline phosphatase^[Ref]

Ocular

Frequency not reported: Abnormal vision, photophobia^[Ref]

Renal

Frequency not reported: Acute renal failure^[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic/anaphylactoid reactions, angioedema^[Ref]

Local

Postmarketing reports: Local pain/burning (IV formulation)^[Ref]