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).
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For the consumer For the professional
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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:
Seek medical attention right away if any of these SEVERE side effects occur 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:
Seek medical attention right away if any of these SEVERE side effects occur when using Anzemet Tablets:Chills; diarrhea; dizziness; fever; headache; indigestion; itching; lightheadedness; tiredness.
TopSevere 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.
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).
| 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).
| 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 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.
TopAnzemet 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).
|
Event |
Anzemet Injection 1.8 mg/kg (n=695) |
Ondansetron/ Granisetron* (n=356) |
||
|---|---|---|---|---|
| Headache | 169 | (24.3%) | 73 | (20.5%) |
| Diarrhea | 89 | (12.4%) | 25 | (7.0%) |
| Fever | 30 | (4.3%) | 18 | (5.1%) |
| Fatigue | 25 | (3.6%) | 12 | (3.4%) |
| Hepatic Function Abnormal† | 25 | (3.6%) | 12 | (3.4%) |
| Abdominal Pain | 22 | (3.2%) | 7 | (2.0%) |
| Hypertension | 20 | (2.9%) | 9 | (2.5%) |
| Pain | 17 | (2.4%) | 7 | (2.0%) |
| Dizziness | 15 | (2.2%) | 7 | (2.0%) |
| Chills/Shivering | 14 | (2.0%) | 6 | (1.7%) |
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).
|
Event |
Anzemet Injection 12.5 mg (n=615) |
Placebo (n=739) |
|---|---|---|
| Headache | 58 (9.4%) | 51 (6.9%) |
| Dizziness | 34 (5.5%) | 23 (3.1%) |
| Drowsiness | 15 (2.4%) | 18 (2.4%) |
| Pain | 15 (2.4%) | 21 (2.8%) |
| Urinary Retention | 12 (2.0%) | 16 (2.2%) |
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–dyspnea, polyuria, acute renal failure.
Vascular (Extracardiac): Local pain or burning on IV administration; rarely–peripheral ischemia, thrombophlebitis/phlebitis.
TopMore resources:
Anzemet - Includes detailed dosage instructions.
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