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Labetalol (Labetalol Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Labetalol hydrochloride injection is usually well tolerated. Most adverse effects have been mild and transient and, in controlled trials involving 92 patients, did not require labetalol HCl 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 hydrochloride injection. 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 hydrochloride injection with the incidence per 100 patients as noted:

Cardiovascular System

Ventricular arrhythmia in 1.

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.

Psychiatric Disorders

Somnolence/yawning in 3.

Respiratory System

Wheezing in 1.

Skin

Pruritus in 1.

The incidence of adverse reactions depends upon the dose of labetalol HCl. The largest experience is with oral labetalol HCl (see labetalol HCl tablet product information for details). Certain of the side effects increased with increasing oral dose, as shown in the following table that depicts the entire U.S. therapeutic trials data base for adverse reactions that are clearly or possibly dose related.

Labetalol Daily Dose (mg) 200 300 400 600 800 900 1200 1600 2400
Number of patients 522 181 606 608 503 117 411 242 175
Dizziness (%) 2 3 3 3 5 1 9 13 16
Fatigue 2 1 4 4 5 3 7 6 10
Nausea <1 0 1 2 4 0 7 11 19
Vomiting 0 0 <1 <1 <1 0 1 2 3
Dyspepsia 1 0 2 1 1 0 2 2 4
Paresthesia 2 0 2 2 1 1 2 5 5
Nasal stuffiness 1 1 2 2 2 2 4 5 6
Ejaculation failure 0 2 1 2 3 0 4 3 5
Impotence 1 1 1 1 2 4 3 4 3
Edema 1 0 1 1 1 0 1 2 2

In addition, a number of other less common adverse events have been reported:

Cardiovascular

Hypotension, and rarely, syncope, bradycardia, heart block.

Liver and Biliary System

Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.

Hypersensitivity

Rare reports of hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea) and anaphylactoid reactions.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol HCl during investigational use and extensive foreign marketing experience.

Clinical Laboratory Tests

Among patients dosed with labetalol hydrochloride tablets, there have been reversible increases of serum transaminases in 4% of patients tested and, more rarely, reversible increases in blood urea.

To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.



REPORTS OF SUSPECTED LABETALOL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Labetalol. The information is not vetted and should not be considered as verified clinical evidence.

Possible Labetalol side effects / adverse reactions in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-03-20

Patient: 70 year old male

Reactions: Drug Ineffective, Blood Pressure Abnormal

Suspect drug(s):
Norvasc
    Dosage: unk

Hydrochlorothiazide
    Dosage: unk

Labetalol
    Dosage: unk



See index of all Labetalol side effect reports >>

Drug label data at the top of this Page last updated: 2012-09-27

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