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mannitol injection, USP Adverse Reactions


The following adverse reactions associated with the use mannitol were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity reactions:Cardiac arrest, anaphylaxis, hypotension, dyspnea, hypertension, pyrexia, chills, sweating, cough, musculoskeletal stiffness, myalgia, urticaria/rash, pruritus, generalized pain, discomfort, nausea, vomiting, headache [see Warnings and Precautions (5.1)]
Renal failure:Acute kidney injury, osmotic nephrosis, anuria, oliguria, urinary retention [see Warnings and Precautions (5.2)]
CNS toxicity:Coma, seizures, confusion, lethargy, rebound increase in intracranial pressure, headache, dizziness [see Warnings and Precautions (5.3)]
Fluid and electrolyte imbalances:Metabolic acidosis, dehydration (hypovolemia), hypervolemia, hyponatremia, hypernatremia, hyperkalemia, hypokalemia [see Warnings and Precautions (5.4)]
Infusion site reactions:Venous thrombosis, thrombophlebitis extending from the site of injection, compartment syndrome and swelling associated with extravasation [see Warnings and Precautions 5.6)]
Cardiac and respiratory disorders:Tachycardia, angina-like chest pain, congestive heart failure, pulmonary congestion, hypotension, edema, rhinitis
Gastrointestinal disorders:Dryness of mouth, nausea, vomiting
General disorders:Thirst
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