Labetalol Side Effects

Brand Names: Normodyne, Trandate

Please note - some side effects for Labetalol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Labetalol - for the Consumer

Labetalol

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Labetalol:

Dizziness; indigestion; lightheadedness; nausea; pain, swelling, or redness at the injection site; stuffy nose; temporary tingling of the scalp; unusual tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; decreased sexual ability; fever, chills, or persistent sore throat; mental or mood changes; muscle pain or tenderness; persistent loss of appetite; right upper stomach pain; shortness of breath; slow heartbeat; swelling of the hands or feet; unusual bruising or bleeding; vision changes; yellowing of the skin or eyes.

Labetalol Tablets

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Labetalol Tablets:

Dizziness; indigestion; lightheadedness; nausea; stuffy nose; temporary tingling of the scalp; unusual tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; dark urine; decreased sexual ability; fever, chills, or persistent sore throat; mental or mood changes; muscle pain or tenderness; persistent loss of appetite; right upper stomach pain; shortness of breath; slow heartbeat; swelling of the hands or feet; unusual bruising or bleeding; yellowing of the skin or eyes.

Labetalol Side Effects - for the Professional

Labetalol

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 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 HCl 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 7; hypoesthesia (numbness) and vertigo, 1 each.

Gastrointestinal System Nausea in 13; vomiting 4; dyspepsia and taste distortion, 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. Certain of the side effects increased with increasing oral dose as shown in the table below which depicts the entire U.S. therapeutic trials data base for adverse reactions that are clearly or possibly dose related.

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 (eg, 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 HCl tablets, there have been reversible increases of serum transaminases in 4% of patients tested, and more rarely, reversible increases in blood urea.

Side Effects by Body System

Cardiovascular

Many of the most common side effects of labetalol resolve with dosage reduction. Orthostatic hypotension/dizziness is usually mild to moderate, transient, and confined to the first few hours after labetalol administration.

Beta-blockers, such as labetalol, are used with caution in patients with claudication or Raynaud's phenomenon due to inhibition of the normal vascular response to low blood flow states.

Cardiovascular side effects are the most common. Fatigue and dizziness have been reported in 3% and up to 12% of patients, respectively. In patients who are receiving 2,400 mg per day or more, however, the incidence of these side effects climbs to 10% and 16%, respectively. Claudication or Raynaud's phenomenon has been reported in 3% of patients. Labetalol may depress cardiac output in 1% of patients, which may be important in some patients with heart failure. Edema, postural hypotension, and bradycardia have also been reported.

Respiratory

Respiratory side effects from beta-blockers, due to inhibition of normal bronchodilation, may be important in patients with a history of reversible airways disease. Nasal stuffiness occurs in less than 5% of patients, and is thought to be due to the alpha-adrenergic blocking properties of labetalol. Dyspnea has also been reported rarely.

Endocrine

Endocrinologic side effects of labetalol include masking of the normal response to hypoglycemia (sweating and tachycardia). This may be important in some patients with diabetes mellitus.

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, dyspepsia, abdominal pain, taste distortion and diarrhea have been reported.

Nervous system

Nervous system side effects scalp tingling (7%) have been reported. Headaches, asthenia, paresthesias, fatigue, dizziness, vertigo, drowsiness, nightmares or dreams, tremors, blurry vision, and general weakness are reported in less than 5% of patients.

Hepatic

Hepatic side effects are rare. Transient elevations of liver function tests have been reported in 4% of patients. Cholestatic jaundice and hepatitis have been reported in rare cases. One case of associated hepatitis was fatal.

A 63-year-old woman with hypertension developed diarrhea, dark urine, and nausea associated with elevated liver function tests within 90 days after beginning labetalol. Serology was negative for a viral etiology, and the patient had no blood transfusions, known food exposure, or alcohol use. Her signs and symptoms resolved upon discontinuation of labetalol. Several months later, the drug was reinstated, and the patient, within two months, became anorectic with recurrent signs and symptoms of hepatitis. A complete work-up was unremarkable. The disease progressed to hepatic encephalopathy and death.

In patients with liver disease, frequent monitoring of liver function tests is recommended.

Metabolic

Nonselective beta-blockers may inhibit the Na-K ATPase pump independent of aldosterone or insulin.

Metabolic side effects are extremely rare. There have been at least three case reports of severe hyperkalemia in post renal transplant patients who were given intravenous labetalol.

Hypersensitivity

A 47-year-old woman with hypertension suffered acute generalized erythema, urticaria, pruritus, and angioedema 30 to 60 minutes after receiving her first dose of labetalol 100 mg. During urination, she became markedly hypotensive, which was associated with a pulse of 30 beats per min. She was successfully resuscitated; rechallenge was not undertaken.

Hypersensitivity reactions are rare. A variety of skin rashes, including a maculopapular erythematous rash, urticaria, atypical lichen planus, and bullous lichen planus have been reported in rare cases. A single case each of anaphylaxis and fever associated with labetalol have been reported.

Genitourinary

Genitourinary complaints are rare. Urinary retention has been reported in less than 5% of patients, and is believed to be due to the alpha-adrenergic blocking properties of labetalol. Decreased libido, impotence, priapism, ejaculatory failure, and retrograde ejaculation have rarely been reported.

Immunologic

A 45-year-old woman developed polyarthralgias and muscle tenderness without a rash six months after beginning labetalol for hypertension. Associated laboratory findings included a raised ANA. Her signs and symptoms gradually resolved upon substitution with propranolol and institution of indomethacin therapy.

Immunologic reactions associated with labetalol, as with some other beta-blockers, include the development of a positive antinuclear antibody (ANA) titer in approximately 2% of patients. Rare cases of labetalol-induced systemic lupus erythematosus have been reported.

Musculoskeletal

Musculoskeletal pain has been reported in rare cases. In at least one case, serum skeletal muscle enzyme levels were elevated and findings of electromyography and electron microscopy were consistent with drug-induced myositis.

Dermatologic

Dermatologic side effects including rash have been reported rarely.

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