openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 2 matching rows.
adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Hepatic Injury [ see WARNINGS AND PRECAUTIONS ( 5.1 ) ] • Serious Skin Reactions [ see WARNINGS AND PRECAUTIONS ( 5.2 ) ] • Allergy and Hypersensitivity [ see WARNINGS AND PRECAUTIONS ( 5.4 ) ] The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mallinckrodt Hospital Products Inc. at 1-800-778-7898 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice. Adult Population A total of 1020 adult patients have received OFIRMEV in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17.0% (n=173) who received more than 10 doses. Most patients were treated with OFIRMEV 1000 mg every 6 hours. A total of 13.1% (n=134) received OFIRMEV 650 mg every 4 hours. All adverse reactions that occurred in adult patients treated with either OFIRMEV or placebo in repeated dose, placebo-controlled clinical trials at an incidence ≥ 3% and at a greater frequency than placebo are listed in Table 3. The most common adverse events in adult patients treated with OFIRMEV (incidence ≥ 5% and greater than placebo) were nausea, vomiting, headache, and insomnia. Table 3. Treatment-Emergent Adverse Reactions Occurring ≥ 3% of OFIRMEV-treated Patients and at a greater frequency than Placebo in Placebo-Controlled, Repeated Dose Studies System Organ Class – Preferred Term OFIRMEV (N=402) n (%) Placebo (N=379) n (%) Gastrointestinal Disorders Nausea Vomiting 138 (34) 62 (15) 119 (31) 42 (11) General Disorders and Administration Site Conditions Pyrexia* 22 (5) 52 (14) Nervous System Disorders Headache 39 (10) 33 (9) Psychiatric Disorders Insomnia 30 (7) 21 (5) Other Adverse Reactions Observed During Clinical Studies of OFIRMEV in Adults The following additional treatment-emergent adverse reactions were reported by adult subjects treated with OFIRMEV in all clinical trials (n=1020) that occurred with an incidence of at least 1% and at a frequency greater than placebo (n=525). Blood and lymphatic system disorders : anemia General disorders and administration site conditions : fatigue, infusion site pain, edema peripheral Investigations : aspartate aminotransferase increased, breath sounds abnormal Metabolism and nutrition disorders : hypokalemia Musculoskeletal and connective tissue disorders : muscle spasms, trismus Psychiatric disorders : anxiety Respiratory, thoracic and mediastinal disorders : dyspnea Vascular disorders : hypertension, hypotension Pediatric Population A total of 355 pediatric patients (47 neonates, 64 infants, 171 children, and 73 adolescents) have received OFIRMEV in active-controlled (n=250) and open-label clinical trials (n=225), including 59.7% (n=212) who received 5 or more doses and 43.1% (n=153) who received more than 10 doses. Pediatric patients received OFIRMEV doses up to 15 mg/kg on an every 4 hours, every 6 hours, or every 8 hours schedule. The maximum exposure was 7.7, 6.4, 6.8, and 7.1 days in neonates, infants, children, and adolescents, respectively. The most common adverse events (incidence ≥ 5%) in pediatric patients treated with OFIRMEV were nausea, vomiting, constipation, pruritus, agitation, and atelectasis. Other Adverse Reactions Observed During Clinical Studies of OFIRMEV in Pediatrics The following additional treatment-emergent adverse reactions were reported by pediatric subjects treated with OFIRMEV (n=355) that occurred with an incidence of at least 1%. Blood and lymphatic system disorders : anemia Cardiac disorders : tachycardia Gastrointestinal disorders : abdominal pain, diarrhea General disorders and administration site conditions : injection site pain, edema peripheral, pyrexia Investigations : hepatic enzyme increase Metabolism and nutrition disorders : hypoalbuminemia, hypokalemia, hypomagnesemia, hypophosphatemia, hypervolemia Musculoskeletal and connective tissue disorders : muscle spasm, pain in extremity Nervous system disorders : headache Psychiatric disorders : insomnia Renal and urinary disorders : oliguria Respiratory, thoracic and mediastinal disorders : pulmonary edema, hypoxia, pleural effusion, stridor, wheezing Skin and subcutaneous tissue disorders : periorbital edema, rash Vascular disorders : hypertension, hypotension