Anzemet Tablets
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Anzemet Tablets
Anzemet Tablets Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Anzemet (dolasetron mesylate) is used to prevent nausea and vomiting that may be caused by surgery or by medicine to treat cancer (chemotherapy). It is an antinauseant and antiemetic agent. Common side effects include headache, constipation, tiredness, drowsiness, or dizziness.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Anzemet Tablets in Detail - Patient Information: Side Effects
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.
Call your doctor at once if you have a serious side effect such as:
- fast or pounding heartbeats;
- feeling like you might pass out;
- slow heart rate, weak pulse, fainting, slow breathing; or
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.
Less serious side effects may include:
- headache;
- tired feeling;
- diarrhea or constipation;
- chills, shivering;
- dizziness;
- fever, sweating; or
- rash.
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) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Anzemet Tablets Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: stomach/abdominal pain, change in amount of urine, vision changes.
Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, severe dizziness, fainting, slow/fast/irregular heartbeat.
A very serious allergic reaction to this drug is unlikely, but stop taking this medication and seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Anzemet Tablets (Dolasetron)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Anzemet Tablets FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Chemotherapy Patients
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 4).
Table 4: Adverse Events ≥ 2% from Chemotherapy-Induced
Nausea and Vomiting Studies
| Event | 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%) |
Postoperative Patients
In controlled clinical trials, 936 adult female patients have received oral ANZEMET for the prevention of postoperative nausea and vomiting. Following is a listing of all adverse events reported in ≥ 2% of patients receiving either placebo or ANZEMET for prevention of postoperative nausea and vomiting in controlled clinical trials (Table 5).
Table 5: Adverse Events ≥ 2% from Placebo-Controlled Postoperative
Nausea and Vomiting Studies
| Event | ANZEMET 100 mg (N=228) | Placebo (N=231) |
| Headache | 16(7.0%) | 11(4.8%) |
| Hypotension | 12(5.3%) | 15(6.5%) |
| Dizziness | 10(4.4%) | 0(0.0%) |
| Fever | 8(3.5%) | 7(3.0%) |
| Pruritus | 7(3.1%) | 8(3.5%) |
| Oliguria | 6(2.6%) | 3(1.3%) |
| Hypertension | 5(2.2%) | 7(3.0%) |
| Tachycardia | 5(2.2%) | 2(0.9%) |
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 or surgery:
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) »
Additional Anzemet Tablets Information
Anzemet Tablets - User Reviews
Anzemet Tablets User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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