Dolasetron Side Effects

Some side effects of dolasetron may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dolasetron: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking dolasetron: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

• feeling like you might pass out;

• slow heart rate, weak pulse, slow breathing;

• swelling in your hands or feet;

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats; or

• urinating less than usual or not at all.

Less serious side effects of dolasetron may include:

• mild headache;

• tired feeling, mild dizziness;

• diarrhea, constipation, upset stomach, loss of appetite;

• chills, shivering, numbness or tingly feeling;

• fever, sweating;

• rash; or

• joint or muscle pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to dolasetron: intravenous solution, oral tablet

General

In general, side effects have included fever (4.3%), fatigue (3.6%), pain (2.4%), and chills/shivering (2.0%).

In some controlled clinical trials, dolasetron was tested for use in the prevention of nausea and vomiting associated with moderately-emetogenic cancer chemotherapy (CINV). Patients in these trials primarily received concurrent high-dose cisplatin. In other controlled trials, dolasetron was tested for use patients for the prevention or treatment of postoperative nausea and vomiting (PONV). For many of the effects listed below, whether the patient received concurrent chemotherapy was not specified in the literature.

Nervous system

Nervous system side effects including headaches (9.4% to 24.3%), lightheadedness (13%), and dizziness (2.2% to 5.5%) have been reported. Flushing, vertigo, paresthesia, and tremor have been reported infrequently. Ataxia and twitching have been reported rarely.

Gastrointestinal

Gastrointestinal side effects have included appetite (12% to 26.6%), diarrhea (6.0% to 12.4%), nausea (6.3% to 7%), abdominal pain (3.2%), and constipation (3.2%). Dyspepsia, abdominal pain, and anorexia have been reported infrequently. Pancreatitis has also been reported rarely.

Hepatic

Increases in AST and ALT did not appear to be related to dose or duration of therapy, and were not associated with symptomatic hepatic disease.

Hepatic side effects have included abnormal hepatic function (3.6%) including transient increases in AST (SGOT) and/or ALT (SGPT) (less than 1%). Hyperbilirubinemia and increased GGT have been reported rarely.

Cardiovascular

Cardiovascular side effects have rarely included hypotension, edema, peripheral edema, Mobitz I AV block, chest pain, orthostatic hypotension, myocardial ischemia, syncope, severe bradycardia, palpitations, bradycardia, tachycardia, T wave change, ST-T wave change, sinus arrhythmia, extrasystole, poor R wave progression, bundle branch block, nodal arrhythmia, U wave change, atrial flutter/fibrillation, peripheral ischemia, and thrombophlebitis/phlebitis. Rarely, cases of sustained supraventricular and ventricular arrhythmias, cardiac arrest leading to death, and myocardial infarction have been reported during postmarketing experience.

Similarly, results of a review of the cardiovascular effects of the drug class 5-hydroxytryptamine 3 receptor antagonists in the literature reported that electrocardiographic (ECG) changes were so small to be considered clinically insignificant. ECG changes were most noticeable between 1 to 2 hours after a dose of dolasetron and returned to baseline within 24 hours. To date, no serious cardiac side effects (including torsades de pointes) triggered by ECG interval changes have been connected with the use of 5-HT 3 receptor antagonists.

Dermatologic

Dermatologic side effects have rarely included rash and increased sweating.

Ocular

Ocular side effects have included blurred vision (6.3%), visual disturbance (3.2%), and photophobia (1.6%).

Hematologic

Hematologic side effects have included hematuria, epistaxis, prolonged prothrombin time, increased PTT, anemia, purpura/hematoma, and thrombocytopenia.

Hypersensitivity

Hypersensitivity side effects have rarely included anaphylactic reaction, facial edema, and urticaria.

Metabolic

Metabolic side effects have rarely included increased alkaline phosphatase.

Musculoskeletal

Musculoskeletal side effects have rarely included myalgia and arthralgia.

Psychiatric

Psychiatric side effects have rarely included nervousness (3.2%). Agitation, sleep disorder, and depersonalization have been reported infrequently. Confusion, anxiety, and abnormal dreaming have been reported rarely.

Respiratory

Respiratory side effects have rarely included dyspnea and bronchospasm.

Genitourinary

Genitourinary side effects have rarely included dysuria and polyuria.

Renal

Renal side effects including acute renal failure have been reported.

Other

Other side effects including taste perversion have been reported infrequently. Tinnitus has been reported rarely.

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