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Levatol

Last reviewed on RxList: 11/21/2016
Levatol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/12/2016

Levatol (penbutolol sulfate) is a beta-antagonist drug indicated in the treatment of mild to moderate high blood pressure (arterial hypertension). Side effects of Levatol are usually mild and reversible and include:

  •  headache
  • fatigue
  • dizziness
  • nausea
  • diarrhea
  • upset stomach
  • decreased interest in sex, or
  • cold symptoms (stuffy nose, sneezing, and sore throat)

Serious side effects of Levatol are uncommon but may include chest pain, AV block intensification, rashes, hair loss and Peyronie's disease.

Levatol (penbutolol sulfate) is available only in 20 mg strength tablets. The usual starting and maintenance dose of Levatol is 20 mg given once daily, but may be increased, if necessary. Levatol may interact with digoxin, tizanidine, diuretics (water pills), asthma medications, blood pressure medications also used to treat a prostate disorder, calcium channel blockers, or heart or blood pressure medications. Tell your doctor all medications and supplements you use. There are no adequate and well-controlled studies in pregnant women. Therefore, Levatol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Levatol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Levatol is administered to a nursing woman. Patients, especially those with evidence of coronary artery insufficiency, should be warned against interruption or discontinuation of Levatol without the physician's advice.

Our Levatol (penbutolol sulfate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Levatol Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • slow or uneven heartbeats;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain; or
  • feeling like you might pass out.

Less serious side effects may include:

  • headache;
  • feeling tired;
  • dizziness;
  • nausea, diarrhea, upset stomach;
  • decreased interest in sex; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Levatol (penbutolol sulfate)

Levatol Professional Information

SIDE EFFECTS

levatol® is usually well tolerated in properly selected patients. Most adverse effects observed during clinical trials have been mild and reversible.

Table 1 lists the adverse reactions reported from 4 controlled studies conducted in the United States involving once-a-day administration of levatol® (at doses ranging from 10 to 120 mg) as monotherapy or in combination with hydrochlorothiazide. levatol® doses above 40 mg/day are not, however, recommended. The table includes only those events where the prevalence rate in the levatol® group was at least 1.5%, or where the reaction is of particular interest.

Over a dose range from 10 to 40 mg, once a day, fatigue, nausea, and sexual impotence occurred at a greater frequency as the dose was increased.

Table 1: ADVERSE REACTIONS DURING CONTROLLED US STUDIES

Body System
Experience
Penbutolol
(N=628)
Placebo
(N=212)
Propranolol
(N=266)
Body as a Whole % % %
  Asthenia 1.6 0.9 4.9
  Pain, chest 2.4 2.8 2.3
  Pain, limb 2.4 1.4 1.5
Digestive System
  Diarrhea 3.3 1.9 2.6
  Nausea 4.3 0.9 2.3
  Dyspepsia 2.7 1.4 5.3
Nervous System
  Dizziness 4.9 2.4 4.2
  Fatigue 4.4 1.9 2.6
  Headache 7.8 6.1 7.5
  Insomnia 1.9 0.9 2.6
Respiratory System
  Cough 2.1 0.5 1.1
  Dyspnea 2.1 1.4 3.4
  Upper respiratory infection 2.5 3.3 4.9
Skin and Appendages
  Sweating, excessive 1.6 0.5 2.3
Urogenital System
  Impotence, sexual 0.5 0.0 0.8

In a double-blind clinical trial comparing levatol® (40 mg and greater once a day) and propranolol (40 mg or more twice a day), heart rates of less than 60 beats/min. were recorded at least once in 25% of the patients in the group receiving levatol® and in 37% of the patients in the propranolol group. Corresponding figures for heart rates of less than 50 beats/min. were 1.2% and 6% respectively. No symptoms associated with bradycardia were reported.

Discontinuations of levatol® because of adverse reactions have ranged between 2.4% and 6.9% of patients in double-blind, parallel, controlled clinical trials, as compared to 1.8% to 4.1% in the corresponding control groups that were given placebo. The frequency and severity of adverse reactions have not increased during long-term administration of levatol®. The prevalence of adverse reactions reported from 4 controlled clinical trials (referred to in Table 1) as reasons for discontinuation of therapy by ≥ 0.5% of the levatol® group is listed in Table 2.

Table 2: DISCONTINUATIONS DURING CONTROLLED US STUDIES

Body System
Experience
Penbutolol
(N=628)
Placebo
(N=212)
Propranolol
(N=266)
Body as a Whole % % %
  Asthenia 0.6 0.0 0.4
  Pain, chest 0.6 1.4 0.4
Digestive System
  Nausea 0.8 0.0 0.8
Nervous System
  Depression 0.6 0.5 0.8
  Dizziness 0.6 0.0 0.4
  Fatigue 0.5 0.5 0.0
  Headache 0.6 0.5 0.4

Potential Adverse Effects: In addition, certain adverse effects not listed above have been reported with other β-blocking agents and should also be considered as potential adverse effects of levatol®.

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

Cardiovascular: Intensification of AV block (see CONTRAINDICATIONS).

Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm, and respiratory distress.

Hematologic: Agranulocytosis, nonthrombocytopenic and thrombocytopenic purpura.

Gastrointestinal: Mesenteric arterial thrombosis and ischemic colitis.

Miscellaneous: Reversible alopecia and Peyronie's disease. The oculomucocutaneous syndrome associated with the β-blocker practolol has not been reported with levatol® during investigational use and extensive foreign clinical experience.

Read the entire FDA prescribing information for Levatol (penbutolol sulfate)

Related Resources for Levatol

Read the Levatol User Reviews »

© Levatol Patient Information is supplied by Cerner Multum, Inc. and Levatol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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