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adverse reactions
ADVERSE REACTIONS 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.