{"adverse_reactions":["ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling. • Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] • Dermatological Toxicity [see Warnings and Precautions ( 5.2 )] • Benzyl Alcohol Toxicity [see Warnings and Precautions (5.3 )] • Laboratory Test Interferences [see Warnings and Precautions ( 5.4 )] • Use in Patients with a History of Adverse Reactions to Thiol Compounds [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (> 10%) when mesna is given with ifosfamide are nausea, vomiting, constipation, leukopenia, fatigue, fever, anorexia, thrombocytopenia, anemia, granulocytopenia, diarrhea, asthenia, abdominal pain, headache, alopecia, and somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-332-1088 or www.fda.gov/medwatch. \"1-800-FDA-1088\""],"effective_time":"20240209","id":"2d60015b-0e21-471d-8a31-20704dd8ae93","openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0143-9260-01 Rx only Mesna Injection 1 g/10 mL (100 mg/mL) FOR INTRAVENOUS USE 10 mL Mutliple-Dose Vial NDC 0143-9260-01 Rx only Mesna Injection 1 g/10 mL (100 mg/mL) FOR INTRAVENOUS USE 10 mL Mutliple-Dose Vial carton unit label carton"],"set_id":"6d5b28d0-8e5a-4c62-a3e9-03c78524e6c8","spl_product_data_elements":["mesna mesna MESNA 2-MERCAPTOETHANESULFONIC ACID EDETATE DISODIUM BENZYL ALCOHOL SODIUM HYDROXIDE HYDROCHLORIC ACID"],"version":"5"}