6 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 |