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Anzemet Tablets

Last reviewed on RxList: 9/27/2013
Anzemet Tablets Side Effects Center

Last reviewed on RxList 2/5/2016

Anzemet (dolasetron mesylate) is an antinauseant and antiemetic agent used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy). Common side effects of Anzemet include headache, constipation, tiredness, drowsiness, dizziness, diarrhea, upset stomach, loss of appetite, chills, shivering, numbness or tingly feeling, fever, sweating, rash, or joint or muscle pain.

The recommended adult oral dosage of Anzemet is 100 mg given within one hour before chemotherapy. Anzemet may interact with arsenic trioxide, droperidol, diuretics, antibiotics, antidepressants, anti-malaria medications, heart rhythm medicines, other medicine to prevent or treat nausea and vomiting, medicines to treat psychiatric disorders, migraine headache medicine, or narcotics. Tell your doctor all medications and supplements you use. Anzemet should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Anzemet (dolasetron mesylate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Anzemet Tablets Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Anzemet Tablets (Dolasetron)

Anzemet Tablets Professional Information

SIDE EFFECTS

In controlled clinical trials, 943 adult cancer patients received ANZEMET Tablets. These patients were receiving concurrent chemotherapy, predominantly cyclophosphamide and doxorubicin regimens. The following adverse events were reported in ≥ 2% of patients receiving either ANZEMET 25 mg or ANZEMET 100 mg tablets for prevention of cancer chemotherapy induced nausea and vomiting in controlled clinical trials (Table 3).

Table 3: Adverse Events ≥ 2% from Chemotherapy-Induced Nausea and Vomiting Studies

  ANZEMET
25 mg
(N=235)
100 mg
(N=227)
Headache 42 (17.9%) 52 (22.9%)
Fatigue 6 (2.6%) 13 (5.7%)
Diarrhea 5 (2.1%) 12 (5.3%)
Bradycardia 12 (5.1%) 9 (4.0%)
Dizziness 3 (1.3%) 7 (3.1%)
Pain 0 7 (3.1%)
Tachycardia 7 (3.0%) 6 (2.6%)
Dyspepsia 7 (3.0%) 5 (2.2%)
Chills/Shivering 3 (1.3%) 5 (2.2%)

In clinical trials, the following reported adverse events, assessed by investigators as treatment-related or causality unknown, occurred following oral or intravenous administration of ANZEMET in < 2% of adult patients receiving concomitant cancer chemotherapy:

Cardiovascular: Hypotension; edema, peripheral edema. The following events also occurred and with a similar frequency as placebo and/or active comparator: Mobitz I AV block, chest pain, orthostatic hypotension, myocardial ischemia, syncope, severe bradycardia, and palpitations. See PRECAUTIONS section for information on potential effects on ECG.

In addition, the following asymptomatic treatment-emergent ECG changes were seen at rates less than or equal to those for active or placebo controls: bradycardia, T wave change, ST-T wave change, sinus arrhythmia, extrasystole (APCs or VPCs), poor R-wave progression, bundle branch block (left and right), nodal arrhythmia, U wave change, atrial flutter/fibrillation.

Furthermore, severe hypotension, bradycardia and syncope have been reported immediately or closely following IV administration.

Dermatologic: Rash, increased sweating.

Gastrointestinal System: Constipation, dyspepsia, abdominal pain, anorexia; pancreatitis.

Hearing, Taste and Vision: Taste perversion, abnormal vision, tinnitus, photophobia.

Hematologic: Hematuria, epistaxis, prothrombin time prolonged, PTT increased, anemia, purpura/hematoma, thrombocytopenia.

Hypersensitivity: Anaphylactic reaction, facial edema, urticaria.

Liver and Biliary System: Transient increases in AST (SGOT) and/or ALT (SGPT) values have been reported as adverse events in less than 1% of adult patients receiving ANZEMET in clinical trials. The increases did not appear to be related to dose or duration of therapy and were not associated with symptomatic hepatic disease. Similar increases were seen with patients receiving active comparator. Hyperbilirubinemia, increased GGT.

Metabolic and Nutritional: Alkaline phosphatase increased.

Musculoskeletal: Myalgia, arthralgia.

Nervous System: Flushing, vertigo, paresthesia, tremor; ataxia, twitching.

Psychiatric: Agitation, sleep disorder, depersonalization; confusion, anxiety, abnormal dreaming.

Respiratory System: Dyspnea, bronchospasm.

Urinary System: Dysuria, polyuria, acute renal failure.

Vascular (Extracardiac): Local pain or burning on IV administration; peripheral ischemia, thrombophlebitis/phlebitis.

Postmarketing Experience

There are reports of wide complex tachycardia or ventricular tachycardia and of ventricular fibrillation cardiac arrest following intravenous administration.

Read the entire FDA prescribing information for Anzemet Tablets (Dolasetron)

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© Anzemet Tablets Patient Information is supplied by Cerner Multum, Inc. and Anzemet Tablets Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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