Trandate Side Effects

Generic Name: labetalol

Note: This document contains side effect information about labetalol. Some of the dosage forms listed on this page may not apply to the brand name Trandate.

Some side effects of Trandate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to labetalol: oral tablet

Other dosage forms:

Along with its needed effects, labetalol (the active ingredient contained in Trandate) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking labetalol:

Less common
  • Blurred vision or other changes in vision
  • chills
  • cold sweats
  • confusion
  • difficult or labored breathing
  • dizziness, faintness, or lightheadedness when getting up from lying or sitting position
  • shortness of breath
  • swelling of face, fingers, feet, or lower legs
  • tightness in chest
  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur while taking labetalol:

Symptoms of overdose
  • Chest pain or discomfort
  • lightheadedness, dizziness, or fainting
  • slow or irregular heartbeat
  • sweating
  • unusual tiredness or weakness

Some side effects of labetalol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Nausea
Less common
  • Acid or sour stomach
  • belching
  • change in taste or bad, unusual, or unpleasant (after) taste
  • decreased interest in sexual intercourse
  • feeling of constant movement of self or surroundings
  • headache
  • heartburn
  • inability to have or keep an erection
  • indigestion
  • lack or loss of strength
  • loss in sexual ability, desire, drive, or performance
  • not able to ejaculate semen
  • rash
  • sensation of spinning
  • stomach discomfort, upset, or pain
  • stuffy nose
Rare
  • Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • diarrhea
  • increased sweating
  • vomiting

For Healthcare Professionals

Applies to labetalol: compounding powder, intravenous solution, oral tablet

Cardiovascular

Many of the most common side effects of labetalol (the active ingredient contained in Trandate) 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 (the active ingredient contained in Trandate) Dyspnea has also been reported rarely.

Endocrine

Endocrinologic side effects of labetalol (the active ingredient contained in Trandate) 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 (the active ingredient contained in Trandate) 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 (the active ingredient contained in Trandate) 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 (the active ingredient contained in Trandate) 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.

Ocular

Ocular side effects have included Intraoperative Floppy Iris Syndrome (IFIS) observed during cataract surgery in some patients treated with alpha-1 blockers (such as labetalol (the active ingredient contained in Trandate) .

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