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Company Novartis / ACE / Age Group / CASE / / Country Germany / France / Japan / United States / / Event FDA Phase / / Facility Patient stable / / IndustryTerm treatment of venous disease / treatment of hypertension / / MedicalCondition renal tubular disorder / Allergic reaction / cranial and pulmonary malformations / pediatric hypertension / chest pain / chronic venous insufficiency / right inguinal hernia / venous disease / dry lung syndrome / hemorrhoidal disease / Pneumothorax / thrombocytopenia / Alopecia / syncope / Cardio-respiratory distress / Pulmonary / pulmonary hypoplasia / injury / Hypersensitivity / Nephrocalcinosis / hepatitis / muscle cramps / Constipation / Pruritus / Back pain / influenza / birth defects / persistent pulmonary hypertension / hypotension / Respiratory disorder / hyperkalemia / insomnia / intrauterine growth retardation / superior sagittal sinus thrombosis / hypertension / ventricular dysfunction / Respiratory failure / Respiratory acidosis / developed oligohydramnios / Hypothyroidism / Migraines / patent ductus arteriosus / Shock / fetal injury / oliguria / Event* Outcome* Oligohydramnios / Diabetes / Hyperlipidemia / itching / Pulmonary hypertension / vomiting / Renal insufficiency / myocardial infarction / Inguinal hernia / heart failure / angioedema / thumb contractures / Hypotonia / Oligohydramnios / contractures / renal failure / Hyperhomocysteinemia / anuria / paresthesia / acute renal failure / Muscular hypotonia / hypercholesterolemia / Respiratory distress / Newborn experienced shock / / MedicalTreatment medication error / resuscitation / dialysis / / OperatingSystem OSE / / Organization office of New Drugs / office of Surveillance and Epidemiology / Team Leader Division of Pharmacovigilance / Research office of Surveillance and Epidemiology Date / Director office of Pediatric Therapeutics / Safety Evaluator Division of Pharmacovigilance / Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation / / Person Lisa L. Mathis / Mark Avigan / Baby / Cindy Kortepeter / M. Dianne Murphy / Monika Houstoun / / / Position counsel / physician / Director / Associate Director / EXECUTIVE / Director Pediatric and Maternal Health Staff / / Product Valsartan / Hydroxyzine / Diovan / Bumetanide / Glyburide / Alprazolam / Hydrochlorothiazide / CDER Subject / / Technology ultrasound / dialysis / / SocialTag 
Department of Health and Human Services Public Health Service Food and Drug Administration Center for Drug Evaluation and Research Office of Surveillance and Epidemiology Date: