Trandate Side Effects

Generic Name: labetalol

Note: This page contains side effects data for the generic drug labetalol. It is possible that some of the dosage forms included below may not apply to the brand name Trandate.

It is possible that some side effects of Trandate may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to labetalol: oral tablet

Other dosage forms:

As well as its needed effects, labetalol (the active ingredient contained in Trandate) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking labetalol, check with your doctor immediately:

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

If any of the following symptoms of overdose occur while taking labetalol, get emergency help immediately:

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

Some labetalol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Gastrointestinal

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

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.[Ref]

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.[Ref]

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.[Ref]

Metabolic

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 (the active ingredient contained in Trandate) [Ref]

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

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Dermatologic

Dermatologic side effects including rash have been reported rarely.[Ref]

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) .

References

1. Louis WJ, Brignell MJ, McNeil JJ, et al "Labetalol in hypertension." Lancet 1 (1978): 452-3

2. Michelson EL, Frishman WH, Lewis JE, et al "Multicenter clinical evaluation of long-term efficacy and safety of labetalol in treatment of hypertension." Am J Med Oct 17 (1983): 68-80

3. Tuomilehto J, Nissinen A, Elo J "Experience with labetalol in essential hypertension." Curr Med Res Opin 6 (1980): 407-15

4. Waal-Manning HJ, Simpson FO "Review of long-term treatment with labetalol." Br J Clin Pharmacol 13(1 Suppl) (1982): s65-73

5. Davidov ME, Moir GD, Oland MP, et al "Monotherapy with labetalol in the treatment of mild hypertension: a double-blind study." Am J Med Oct 17 (1983): 47-53

6. Tcherdakoff P "Side-effects with long-term labetalol: an open study of 251 patients in a single centre." Pharmatherapeutica 3 (1983): 342-8

7. Patel RV, Kertland HR, Jahns BE, Zarowitz BJ, Mlynarek ME, Fagan SC "Labetalol: response and safety in critically ill hemorrhagic stroke patients." Ann Pharmacother 27 (1993): 180-1

8. "Product Information. Normodyne (labetalol)." Schering Laboratories, Kenilworth, NJ.

9. Sandler MA, Jacobs LE, Kotler MN "Coronary vasospasm secondary to labetalol in a patient with aortic dissection." Chest 100 (1991): 261-2

10. Bailey RR "Labetalol in the treatment of patients with hypertension and renal functional impairment." Br J Clin Pharmacol 8 (1979): s135-40

11. Myers J, Morgan T, Waga S, et al "Long-term experiences with labetalol." Med J Aust 1 (1980): 665-6

12. Eliasson K, Danielson M, Hylander B, Lindblad LE "Raynaud's phenomenon caused by beta-receptor blocking drugs." Acta Med Scand 215 (1984): 333-9

13. Goa KL, Benfield P, Sorkin EM "Labetalol: a reappraisal of its pharmacology, pharmacokinetics and therapeutic use in hypertension and ischaemic heart disease." Drugs 37 (1989): 583-627

14. Durant PA, Joucken K "Bronchospasm and hypotension during cardiopulmonary bypass after preoperative cimetidine and labetalol therapy." Br J Anaesth 56 (1984): 917-20

15. Adam WR, Meagher EJ, Barter CE "Labetalol, beta blockers, and acute deterioration of chronic airway obstruction." Clin Exp Hypertens A A4 (1982): 1419-28

16. Falliers CJ, Vincent ME, Medakovic M "Effect of single doses of labetalol, metoprolol, and placebo on ventilatory function in patients with bronchial asthma: interaction with isoproterenol." J Asthma 23 (1986): 251-60

17. MacCarthy EP, Bloomfield SS "Labetalol: a review of its pharmacology, pharmacokinetics, clinical uses and adverse effects." Pharmacotherapy 3 (1983): 193-219

18. Stumpf J "Fatal hepatotoxicity induced by hydralazine or labetalol." Pharmacotherapy 11 (1991): 415-8

19. Clark JA, Zimmerman HJ, Tanner LA "Labetalol hepatotoxicity." Ann Intern Med 113 (1990): 210-3

20. Douglas DD, Yang RD, Jensen P, Thiele DL "Fatal labetalol-induced hepatic injury." Am J Med 87 (1989): 235-6

21. Arthur S, Greenberg A "Hyperkalemia associated with intravenous labetalol therapy for acute hypertension in renal transplant recipients." Clin Nephrol 33 (1990): 269-71

22. Arthur S, Greenberg A "Hyperkalemia associated with intravenous labetalol therapy for acute hypertension in renal transplant recipients." Clin Nephrol 33 (1990): 269-71

23. Ferree CE "Apparent anaphylaxis from labetalol." Ann Intern Med 104 (1986): 729-30

24. Stricker BH, Heijermans HS, Braat H, Norg J "Fever induced by labetalol." JAMA 256 (1986): 619-20

25. Law MR, Copland RFP, Armitstead JG, Gabriel R "Labetalol and priapism." Br Med J Jan 12 (1980): 115

26. O'Meara J, White WB "Ejaculatory failure and urinary dysfunction secondary to labetalol." J Urol 139 (1988): 371-2

27. Staughton R, Sutton R, Farrell M "Beta-blockers, autoimmunity, and rashes." Lancet Sep 13 (1980): 581

28. Brown RC, Cooke J, Losowsky MS "SLE syndrome, probably induced by labetalol." Postgrad Med J 57 (1981): 189-90

29. Teicher A, Rosenthal T, Kissin E, Sarova I "Labetalol-induced toxic myopathy." Br Med J 282 (1981): 1824-5

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