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.
ADVERSE REACTIONS Labetalol HCl injection is usually well tolerated.
Most adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require labetalol withdrawal.
Symptomatic postural hypotension (incidence, 58%) is likely to occur if patients are tilted or allowed to assume the upright position within 3 hours of receiving labetalol HCl.
Moderate hypotension occurred in 1 of 100 patients while supine.
Increased sweating was noted in 4 of 100 patients, and flushing occurred in 1 of 100 patients.
The following also were reported with labetalol HCl with the incidence per 100 patients as noted: Cardiovascular System:Ventricular arrhythmia in
Central and Peripheral Nervous Systems: Dizziness in 9, tingling of the scalp/skin in 7, hypoesthesia (numbness) and vertigo in 1 each.
Gastrointestinal System: Nausea in 13, vomiting in 4, dyspepsia and taste distortion in 1 each.
Metabolic Disorders: Transient increases in blood urea nitrogen and serum creatinine levels occurred in 8 of 100 patients;
these were associated with drops in blood pressure, generally in patients with prior renal insufficiency.
WARNINGS Hepatic Injury Severe hepatocellular injury, confirmed by rechallenge in at least one case, occurs rarely with labetalol therapy.
The hepatic injury is usually reversible, but hepatic necrosis and death have been reported.
Injury has occurred after both short- and long-term treatment and may be slowly progressive despite minimal symptomatology.
Similar hepatic events have been reported with a related compound, dilevalol HCl, including two deaths.
Dilevalol HCl is one of the four isomers of labetalol HCl.
Like all medications, Labetalol Hcl 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: