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Normodyne 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 Normodyne.

For the Consumer

Applies to labetalol: oral tablet

Other dosage forms:

Along with its needed effects, labetalol (the active ingredient contained in Normodyne) 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

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

Common (1% to 10%): Edema, postural hypotension

Frequency not reported: Bradycardia, heart block, heart failure, hypotension, ankle edema, increase of an existing intermittent claudication, postural hypotension, cold or cyanotic extremities, Raynaud's phenomenon, paresthesia of the extremities, syncope[Ref]

Dermatologic

Uncommon (0.1% to 1%): Increased sweating

Frequency not reported: Systemic lupus erythematosus, rashes (e.g., generalized maculopapular, lichenoid, urticarial, bullous lichen planus, psoriaform, facial erythema, Peyronie's disease, reversible alopecia)[Ref]

Endocrine

Frequency not reported: Masking of the normal response to hypoglycemia (sweating and tachycardia); this may be important in some patients with diabetes mellitus[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, dyspepsia, vomiting

Uncommon (0.1% to 1%): Diarrhea

Frequency not reported: Epigastric pain[Ref]

Genitourinary

Common (1% to 10%): Ejaculation failure, impotence

Frequency not reported: Difficulty in micturition (including acute urinary bladder retention)[Ref]

Hepatic

Common (1% to 10%): Transient elevations of liver function tests

Frequency not reported: Hepatic necrosis, hepatitis, cholestatic jaundice[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity (e.g., rash, urticaria, pruritus, angioedema, dyspnea), anaphylactoid reactions[Ref]

Immunologic

Frequency not reported: Antimitochondrial antibodies[Ref]

Metabolic

Very rare (less than 0.01%): Hyperkalemia[Ref]

Musculoskeletal

Frequency not reported: Muscle cramps, toxic myopathy[Ref]

Nervous system

Very common (10% or more): Dizziness (11%)

Common (1% to 10%): Headache, taste distortion, vertigo, paresthesia, scalp tingling

Uncommon (0.1% to 1%): Drowsiness

Frequency not reported: Tremor[Ref]

Ocular

Common (1% to 10%): Vision abnormality

Frequency not reported: Dry eyes

Postmarketing reports: Intraoperative Floppy Iris Syndrome (IFIS) observed during cataract surgery[Ref]

Respiratory

Common (1% to 10%): Nasal stuffiness, dyspnea

Frequency not reported: Bronchospasm, interstitial lung disease[Ref]

Other

Common (1% to 10%): Fatigue, asthenia

Frequency not reported: Positive antinuclear factor[Ref]

Psychiatric

Frequency not reported: Depressed mood and lethargy, hallucinations, psychoses, confusion, sleep disturbances, nightmares[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Labetalol Hydrochloride (labetalol)." Watson Pharmaceuticals, Parsippany, NJ.

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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