Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions from voluntary reports or clinical studies have been reported with OSMITROL.
Because many 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, urticarial/rash, pruritus, generalized pain, discomfort, nausea, vomiting, and headache.
[see Warnings and Precautions (5.1) ] • Renal Failure : acute kidney injury, osmotic nephrosis, azotemia, anuria, hematuria, oliguria, polyuria [see Warnings and Precautions (5.2) ] • CNS Toxicity : coma, seizures, confusion, lethargy;
rebound increase in intracranial pressure;
dizziness [see Warnings and Precautions (5.3) ] • Fluid and Electrolyte Imbalances : hypovolemia, hypervolemia, peripheral edema, dehydration, hyponatremia, hypernatremia, hyperkalemia, hypokalemia;
metabolic acidosis [see Warnings and Precautions (5.4) ] • Infusion Site Reactions : phlebitis, inflammation, pain, rash, erythema, pruritus;
compartment syndrome and swelling associated with extravasation [see Warnings and Precautions (5.6) ] • Cardiac and Respiratory Disorders : congestive cardiac failure, pulmonary edema, palpitations • Gastrointestinal Disorders : thirst, dry mouth • General Disorders : asthenia, malaise The most common adverse reactions are hypersensitivity reactions, renal failure, CNS toxicity, hypo/hypervolemia, hypo/hypernatremia, hypo/hyperkalemia, and infusion site reactions.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions, including anaphylaxis : Stop infusion immediately if hypersensitivity reactions develop.
( 5.1 ) • Renal Complications Including Renal Failure : Risk factors include pre-existing renal failure, concomitant use of nephrotoxic drugs or other diuretics.
Avoid use of nephrotoxic drugs.
Discontinue OSMITROL if renal function worsens.
( 5.2 , 8.6 ) • Central Nervous System (CNS) Toxicity : Confusion, lethargy and coma may occur during or after infusion.
Like all medications, Osmitrol can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: