Anzemet Side Effects

Please note - some side effects for Anzemet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Anzemet - for the Consumer

Anzemet

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Anzemet:

Chills; diarrhea; dizziness; fever; headache; indigestion; itching; lightheadedness; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in heartbeat or irregular heartbeat; chest pain; fainting; numbness or pain of an arm or leg; pounding in the chest; severe lightheadedness; shortness of breath; sudden severe headache, stomach pain, dizziness, or vomiting; sudden vision changes; urination problems.

Anzemet Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Anzemet Tablets:

Chills; diarrhea; dizziness; fever; headache; indigestion; itching; lightheadedness; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in heartbeat or irregular heartbeat; chest pain; fainting; numbness or pain of an arm or leg; pounding in the chest; severe lightheadedness; shortness of breath; sudden severe headache, stomach pain, dizziness, or vomiting; sudden vision changes; urination problems.

Anzemet Side Effects - for the Professional

Anzemet

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).

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).

In clinical trials, the following infrequently reported adverse events, assessed by investigators as treatment-related or causality unknown, occurred following oral or intravenous administration of Anzemet to adult patients receiving concomitant cancer chemotherapy or surgery:

Cardiovascular: Hypotension; rarely–edema, peripheral edema. The following events also occurred rarely 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; rarely–pancreatitis.

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

Hematologic: Rarely–hematuria, epistaxis, prothrombin time prolonged, PTT increased, anemia, purpura/hematoma, thrombocytopenia.

Hypersensitivity: Rarely–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. Rarely–hyperbilirubinemia, increased GGT.

Metabolic and Nutritional: Rarely–alkaline phosphatase increased.

Musculoskeletal: Rarely–myalgia, arthralgia.

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

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

Respiratory System: Rarely–dyspnea, bronchospasm.

Urinary System: Rarely–dysuria, polyuria, acute renal failure.

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

Postmarketing Experience

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

Anzemet Injection

Chemotherapy Patients

In controlled clinical trials, 2265 adult patients received Anzemet Injection. The overall adverse event rates were similar with 1.8 mg/kg Anzemet Injection and ondansetron or granisetron. Patients were receiving concurrent chemotherapy, predominantly high-dose (≥50 mg/m2) cisplatin. Following is a combined listing of all adverse events reported in ≥2% of patients in these controlled trials (Table 4).

Postoperative Patients

In controlled clinical trials with 2550 adult patients, headache and dizziness were reported more frequently with 12.5 mg Anzemet Injection than with placebo. Rates of other adverse events were similar. Following is a listing of all adverse events reported in ≥2% of patients receiving either placebo or 12.5 mg Anzemet Injection for the prevention or treatment of postoperative nausea and vomiting in controlled clinical trials (Table 5).

In clinical trials, the following infrequently reported adverse events, assessed by investigators as treatment-related or causality unknown, occurred following oral or intravenous administration of Anzemet to adult patients receiving concomitant cancer chemotherapy or surgery:

Cardiovascular: Hypotension; rarely–edema, peripheral edema. The following events also occurred rarely 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, tachycardia, 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; rarely–pancreatitis.

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

Hematologic: Rarely–hematuria, epistaxis, prothrombin time prolonged, PTT increased, anemia, purpura/hematoma, thrombocytopenia.

Hypersensitivity: Rarely–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. Rarely–hyperbilirubinemia, increased GGT.

Metabolic and Nutritional: Rarely–alkaline phosphatase increased.

Musculoskeletal: Rarely–myalgia, arthralgia.

Nervous System: Flushing, vertigo, paraesthesia, tremor; rarely–ataxia, twitching.

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

Respiratory System: Rarely–dyspnea, bronchospasm.

Urinary System: Rarely–dysuria, polyuria, acute renal failure.

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

Postmarketing Experience

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

Side Effects by Body System

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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