Very rare (less than 0.01%): Cardiac failureįrequency not reported: Congestive heart failure, tachycardia, arrhythmia, myocardial infarction, palpitations, vasculitis, sinus bradycardia, angina pectoris, thrombotic eventsįrequency not reported: Tachycardia, cardiac failure, hypotension Nervous system Very common (10% or more): Hemorrhage (up to 10%), hypertension (10%), hypotension (10%) Postmarketing reports: GI perforation Cardiovascular Very common (10% or more): GI disorders non-necrotizing enterocolitis (22%)Ĭommon (1% to 10%): Necrotizing enterocolitis, intestinal perforationįrequency not reported: Abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia Very rare (less than 0.01%): Peptic ulcer, perforation, hematemesis, mouth ulceration, exacerbation of colitis, exacerbation of Crohn's diseaseįrequency not reported: Dry mouth, duodenitis, esophagitis, gastric ulcer, duodenal ulcer, GI bleeding, glossitis, rectal bleeding, stomatitis, eructation, gingival ulcer, pancreatitisįor Patent Ductus Arteriosus in Pediatric Patients: Uncommon (0.1% to 1%): Abdominal distention, dyspepsia, gastritis Very common (10% or more): Nausea (up to 57%), vomiting (up to 22%), flatulence (up to 16%), diarrhea (up to 10%)Ĭommon (1% to 10%): Dyspepsia, abdominal discomfort, epigastric pain, heartburn, abdominal distress, indigestion, constipation, abdominal cramps/pain, fullness of GI tract, bloating, GI hemorrhage, melena The most frequently reported adverse effects were gastrointestinal (GI) in nature and included nausea, vomiting, flatulence, and diarrhea.įor Patent Ductus Arteriosus in Pediatric Patients: The most frequently reported adverse effects were sepsis, anemia, intraventricular bleeding, apnea, GI disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, and respiratory failure.
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