Trandate Side Effects

Generic Name: labetalol

Please note - some side effects for Trandate 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 Trandate - for the Consumer

Trandate

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 Trandate:

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.

Trandate 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 Trandate 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.

Trandate Side Effects - for the Professional

Trandate

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 Trandate Tablets 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 HCl, placebo, metoprolol, and propranolol over treatment periods of 3 and 4 months. Where the frequency of adverse effects for labetalol HCl 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.

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.

Clinical trials also included studies utilizing daily doses up to 2,400 mg in more severely hypertensive patients. Certain of the side effects increased with increasing dose, as shown in the following table that depicts the entire US 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:

Body as a Whole: Fever.

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

Central and Peripheral Nervous Systems: Paresthesia, most frequently described as scalp tingling. In most cases, it was mild and transient and usually occurred at the beginning of treatment.

Collagen Disorders: Systemic lupus erythematosus, positive antinuclear factor.

Eyes: Dry eyes.

Immunological System: Antimitochondrial antibodies.

Liver and Biliary System: Hepatic necrosis, hepatitis, cholestatic jaundice, elevated liver function tests.

Musculoskeletal System: Muscle cramps, toxic myopathy.

Respiratory System: Bronchospasm.

Skin and Appendages: Rashes of various types, such as generalized maculopapular, lichenoid, urticarial, bullous lichen planus, psoriaform, and facial erythema; Peyronie's disease; reversible alopecia.

Urinary System: Difficulty in micturition, including acute urinary bladder retention.

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

Following approval for marketing in the United Kingdom, a monitored release survey involving approximately 6,800 patients was conducted for further safety and efficacy evaluation of this product. Results of this survey indicate that the type, severity, and incidence of adverse effects were comparable to those cited above.

Potential Adverse Effects: In addition, other adverse effects not listed above have been reported with other beta-adrenergic blocking agents.

Central Nervous System: Reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, short-term memory loss, emotional lability, slightly clouded sensorium, and decreased performance on psychometrics.

Cardiovascular: Intensification of A-V block.

Allergic: Fever combined with aching and sore throat, laryngospasm, respiratory distress.

Hematologic: Agranulocytosis, thrombocytopenic or nonthrombocytopenic purpura.

Gastrointestinal: Mesenteric artery thrombosis, ischemic colitis.

The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with labetalol HCl.

Clinical Laboratory Tests: There have been reversible increases of serum transaminases in 4% of patients treated with labetalol HCl and 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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