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 Most adverse effects are mild and transient and occur early in the course of treatment.
In controlled clinical trials of 3 to 4 months' duration, discontinuation of labetalol hydrochloride due to one or more adverse effects was required in 7% of all patients.
In these same trials, other agents with solely beta-blocking activity used in the control groups led to discontinuation in 8% to 10% of patients, and a centrally acting alpha-agonist led to discontinuation in 30% of patients.
The incidence rates of adverse reactions listed in the following table were derived from multicenter, controlled clinical trials comparing labetalol hydrochloride, placebo, metoprolol, and propranolol over treatment periods of 3 and 4 months.
Where the frequency of adverse effects for labetalol hydrochloride and placebo is similar, causal relationship is uncertain.
The rates are based on adverse reactions considered probably drug related by the investigator.
If all reports are considered, the rates are somewhat higher (e.g., dizziness, 20%;
nausea, 14%;
fatigue, 11%), but the overall conclusions are unchanged.
Labetalol Hydrochloride (N=227) % Placebo (N=98) % Propranolol (N=84) % Metoprolol (N=49) % Body as a whole Fatigue 5 0 12 12 Asthenia 1 1 1 0 Headache 2 1 1 2 Gastrointestinal Nausea 6 1 1 2 Vomiting less than 1 0 0 0 Dyspepsia 3 1 1 0 Abdominal pain 0 0 1 2 Diarrhea less than 1 0 2 0 Taste distortion 1 0 0 0 Central and Peripheral Nervous Systems Dizziness 11 3 4 4 Paresthesia less than 1 0 0 0 Drowsiness less than 1 2 2 2 Autonomic Nervous System Nasal stuffiness 3 0 0 0 Ejaculation failure 2 0 0 0 Impotence 1 0 1 3 Increased sweating less than 1 0 0 0 Cardiovascular Edema 1 0 0 0 Postural hypotension 1 0 0 0 Bradycardia 0 0 5 12 Respiratory Dyspnea 2 0 1 2 Skin Rash 1 0 0 0 Special Senses Vision abnormality 1 0 0 0 Vertigo 2 1 0 0 The adverse effects were reported spontaneously and are representative of the incidence of adverse effects that may be observed in a properly selected hypertensive patient population, i.e., a group excluding patients with bronchospastic disease, overt congestive heart failure, or other contraindications to beta-blocker therapy.
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 research compound, dilevalol HCl, including two deaths.
Dilevalol HCl is one of the four isomers of labetalol hydrochloride.
Like all medications, Labetalol Hydrochloride 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: