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Dolasetron Side Effects

In Summary

More frequently reported side effects include: dizziness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to dolasetron: oral tablet

Other dosage forms:

In addition to its needed effects, some unwanted effects may be caused by dolasetron. In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

You should check with your doctor immediately if any of these side effects occur when 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

Severity: Minor

Some of the side effects that can occur with dolasetron may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

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]

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]

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]

References

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

2. "Product Information. Anzemet (dolasetron)." Hoechst Marion-Roussel Inc, Kansas City, MO.

Not all side effects for dolasetron may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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