FDA label 2effcdad-6bba-4e82-a3d2-9cacf46ecd1c

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
94fa6c50-de10-4c07-a668-1880061561cc
SPL ID
2effcdad-6bba-4e82-a3d2-9cacf46ecd1c
Version
2
Effective date
2012-05-15
Source export date
2026-09-28
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:16:31

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Cardiac failure Sympathetic stimulation may be a vital component supporting circulatory function in congestive heart failure, and beta-adrenergic receptor blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe heart failure. In hypertensive patients who have congestive heart failure controlled by digitalis and diuretics, beta-blockers should be administered cautiously. Both digitalis and beta-adrenergic receptor blocking agents slow AV conduction. In patients without a history of cardiac failure Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. Therefore at the first sign or symptom of cardiac failure, discontinuation of betaxolol should be considered. In some cases beta-blocker therapy can be continued while cardiac failure is treated with cardiac glycosides, diuretics, and other agents, as appropriate. Exacerbation of angina pectoris upon withdrawal Abrupt cessation of therapy with certain beta-blocking agents in patients with coronary artery disease has been followed by exacerbations of angina pectoris and, in some cases, myocardial infarction has been reported. Therefore, such patients should be warned against interruption of therapy without the physician's advice. Even in the absence of overt angina pectoris, when discontinuation of betaxolol is planned, the patient should be carefully observed and therapy should be reinstituted, at least temporarily, if withdrawal symptoms occur. Bronchospastic diseases PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD NOT IN GENERAL RECEIVE BETA-BLOCKERS. Because of its relative β 1 -selectivity (cardioselectivity), low doses of betaxolol may be used with caution in patients with bronchospastic disease who do not respond to or cannot tolerate alternative treatment. Since β 1 - selectivity is not absolute and is inversely related to dose, the lowest possible dose of betaxolol should be used (5 to 10 mg once daily) and a bronchodilator should be made available. If dosage must be increased, divided dosage should be considered to avoid the higher peak blood levels associated with once-daily dosing. Anesthesia and major surgery The necessity, or desirability, of withdrawal of a beta-blocking therapy prior to major surgery is controversial. Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. While this might be of benefit in preventing arrhythmic response, the risk of excessive myocardial depression during general anesthesia may be increased and difficulty in restarting and maintaining the heart beat has been reported with beta-blockers. If treatment is continued, particular care should be taken when using anesthetic agents which depress the myocardium, such as ether, cyclopropane, and trichloroethylene, and it is prudent to use the lowest possible dose of betaxolol. Betaxolol, like other beta-blockers, is a competitive inhibitor of beta-receptor agonists and its effect on the heart can be reversed by cautious administration of such agents (eg, dobutamine or isoproterenol—see Overdosage ). Manifestations of excessive vagal tone (eg, profound bradycardia, hypotension) may be corrected with atropine 1 to 3 mg IV in divided doses. Diabetes and hypoglycemia Beta-blockers should be used with caution in diabetic patients. Beta-blockers may mask tachycardia occurring with hypoglycemia (patients should be warned of this), although other manifestations such as dizziness and sweating may not be significantly affected. Unlike nonselective beta-blockers, betaxolol does not prolong insulin-induced hypoglycemia. Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs of hyperthyroidism (eg, tachycardia). Abrupt withdrawal of beta-blockade might precipitate a thyroid storm; therefore, patients known or suspected of being thyrotoxic from whom betaxolol is to be withdrawn should be monitored closely ( see Dosage and Administration: Cessation of Therapy) . Betaxolol should not be given to patients with untreated pheochromocytoma.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 3 matching rows.

adverse reactions

ADVERSE REACTIONS Most adverse reactions have been mild and transient and are typical of beta-adrenergic blocking agents, eg, bradycardia, fatigue, dyspnea, and lethargy. Withdrawal of therapy in U.S. and European controlled clinical trials has been necessary in about 3.5% of patients, principally because of bradycardia, fatigue, dizziness, headache, and impotence. Frequency estimates of adverse events were derived from controlled studies in which adverse reactions were volunteered and elicited in U.S. studies and volunteered and/or elicited in European studies. In the U.S., the placebo-controlled hypertension studies lasted for 4 weeks, while the active-controlled hypertension studies had a 22- to 24-week double-blind phase. The following doses were studied: betaxolol—5, 10, 20, and 40 mg once daily; atenolol—25, 50, and 100 mg once daily; and propranolol—40, 80, and 160 mg b.i.d. Betaxolol, like other beta-blockers, has been associated with the development of antinuclear antibodies (ANA) (e.g., lupus erythematosus). In controlled clinical studies, conversion of ANA from negative to positive occurred in 5.3% of the patients treated with betaxolol, 6.3% of the patients treated with atenolol, 4.9% of the patients treated with propranolol, and 3.2% of the patients treated with placebo. Betaxolol adverse events reported with a 2% or greater frequency, and selected events with lower frequency, in U.S. controlled studies are: Table 1 - Adverse Events Report Adverse Events for Betaxolol and Placebo-Treated Patients Dose Range Body System/Adverse Reaction Betaxolol (N=509) 5-40 mg q.d.* (%) Betaxolol (N=73) 40-160 mg b.i.d. (%) Betaxolol (N=75) 25-100 mg b.i.d. (%) Placebo (N=109) (%) Cardiovascular (heart rate <50 BPM) Symptomatic bradycardia Edema 8.1 0.8 1.8 4.1 1.4 0 12.0 0 0 0 Central Nervous System Headache Dizziness Fatigue Lethargy 6.5 4.5 2.9 2.8 4.1 11.0 9.6 4.1 5.3 2.7 4.0 2.7 15.6 5.5 0 0.9 Psychiatric Insomnia Nervousness Bizarre dreams Depression 1.2 0.8 1.0 0.8 8.2 1.4 2.7 2.7 2.7 2.7 1.3 4.0 0 0 0 0 Autonomic Impotence 1.2† 0 0 0 Respiratory Dyspnea Pharyngitis Rhinitis Upper respiratory infection 2.4 2.0 1.4 2.6 2.7 0 0 0 1.3 4.0 4.0 0 0.9 0.9 0.9 5.5 Gastrointestinal Dyspepsia Nausea Diarrhea 4.7 1.6 2.0 6.8 1.4 6.8 2.7 4.0 8.0 0.9 0 0.9 Musculoskeletal Chest pain Arthralgia 2.4 3.1 1.4 0 2.7 4.0 0.9 1.8 Skin Rash 1.2 0 0 0 *Five patients received 80 mg q.d. †N=336 males, impotence is a known possible adverse effect of this pharmacological class. Of the above adverse reactins associated with the use of betaxolol, only bradycardia was clearly dose related, but there was a suggestion of dose relatedness for fatigue, lethargy, and dyspepsia. In Europe, the placebo-controlled study lasted for 4 weeks, while the comparative studies had a 4-52-week double-blind phase. The following doses were studied: betaxolol 20 and 40 mg once daily and atenolol 100 mg once daily. From European controlled hypertension clinical trials, the following adverse events reported by 2% or more patients and selected events with lower frequency are presented: Table 2 - European Controlled Hypertension Clinical Trials Adverse Events Reporting for Betaxolol, Atenolol and Placebo Patients Dose Range Body System/Adverse Reaction Betaxolol (N=155) 20-40 mg q.d. (%) Atenolol (N=81) 100 mg q.d. (%) Placebo (N=60) (%) Cardiovascular Bradycardia (heartrate <50 BPM) Symptomatic bradycardia Palpitation Edema Cold extremities 5.8 1.9 1.9 1.3 1.9 5.0 2.5 3.7 1.2 0 0 0 1.7 0 0 Central Nervous System Headache Dizziness Fatigue Asthenia Insomnia Paresthesia 14.8 14.8 9.7 7.1 5.0 .9 9.9 17.3 18.5 0 3.7 2.5 23.3 15.0 0 16.7 3.3 0 Gastrointestinal Nausea Dyspepsia Diarrhea 5.8 3.9 1.9 1.2 7.4 3.7 0 3.3 0 Musculoskeletal Chest pain Joint pain Myalgia 7.1 5.2 3.2 6.2 4.9 3.7 5.0 1.7 3.3 The only adverse event whose frequency clearly rose with increasing dose was bradycardia. Elderly patients were especially susceptible to bradycardia, which in some cases responded to dose-reduction ( see Precautions ). The following selected (potentially important) adverse events have been reported at an incidence of less than 2% in U.S. controlled and open, long-term clinical studies, European controlled clinical trials, or in marketing experience. It is not known whether a causal relationship exists between betaxolol and these events; they are listed to alert the physician to a possible relationship: Autonomic: flushing, salivation, sweating. Body as a whole: allergy, fever, malaise, pain, rigors. Cardiovascular: angina pectoris, arrhythmia, atrioventricular block, heart failure, hypertension, hypotension, myocardial infarction, thrombosis, syncope. Central and peripheral nervous system: ataxia, neuralgia, neuropathy, numbness, speech disorder, stupor, tremor, twitching. Gastrointestinal: anorexia, constipation, dry mouth, increased appetite, mouth ulceration, rectal disorders, vomiting, dysphagia. Hearing and Vestibular: earache, labyrinth disorders, tinnitus, deafness. Hematologic: anemia, leucocytosis, lymphadenopathy, purpura, thrombocytopenia. Liver and biliary: increased AST, increased ALT. Metabolic and nutritional: acidosis, diabetes, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperlipemia, hyperuricemia, hypokalemia, weight gain, weight loss, thirst, increased LDH. Musculoskeletal: arthropathy, neck pain, muscle cramps, tendonitis. Psychiatric: abnormal thinking, amnesia, impaired concentration, confusion, emotional lability, hallucinations, decreased libido. Reproductive disorders: Female: breast pain, breast fibroadenosis, menstrual disorder; Male: Peyronie's disease, prostatitis. Respiratory: bronchitis, bronchospasm, cough, epistaxis, flu, pneumonia, sinusitis. Skin: alopecia, eczema, erythematous rash, hypertrichosis, pruritus, skin disorders. Special senses: abnormal taste, taste loss. Urinary system: cystitis, dysuria, micturition disorder, oliguria, proteinuria, abnormal renal function, renal pain. Vascular: cerebrovascular disorder, intermittent claudication, leg cramps, peripheral ischemia, thrombophlebitis. Vision: abnormal lacrimation, abnormal vision, blepharitis, ocular hemorrhage, conjunctivitis, dry eyes, iritis, cataract, scotoma. Potential adverse effects Although not reported in clinical studies with betaxolol, a variety of adverse effects have been reported with other beta-adrenergic blocking agents and may be considered potential adverse effects of betaxolol: 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 with slightly clouded sensorium, and decreased performance on neuropsychometric tests. Allergic: Fever combined with aching and sore throat, laryngospasm, respiratory distress. Hematologic: Agranulocytosis, thrombocytopenic purpura, and nonthrombocytopenic purpura. Gastrointestinal: Mesenteric arterial thrombosis, ischemic colitis. Metabolic: Hypoglycemia. Miscellaneous: Raynaud's phenomena. There have been reports of skin rashes and/or dry eyes associated with the use of beta-adrenergic blocking drugs. The reported incidence is small, and in most cases, the symptoms have cleared when treatment was withdrawn. Discontinuation of the drug should be considered if any such reaction is not otherwise explicable. Patients should be closely monitored following cessation of therapy. The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with betaxolol during investigational use and extensive foreign experience. However, dry eyes have been reported.

adverse reactions table

<table width="461" ID="id_125b9169-58ac-42d2-a86d-a13246aa110b"> <caption ID="id_e99e567e-51fa-4f67-a768-dbd9478e8a66">Table 1 - Adverse Events Report</caption> <col width="33.2%"/> <col width="16.7%"/> <col width="19.1%"/> <col width="19.1%"/> <col width="11.9%"/> <tfoot ID="id_535a50bc-6f66-4201-ba9d-cfbf2817fd85"> <tr> <td align="left" valign="top" styleCode="Botrule" colspan="5">Adverse Events for Betaxolol and Placebo-Treated Patients</td> </tr> </tfoot> <tbody> <tr ID="id_ccb1812f-f0b3-46c0-9fe5-72ad87378faf"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Dose Range</paragraph> <paragraph>Body System/Adverse Reaction</paragraph> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Betaxolol </paragraph> <paragraph>(N=509)</paragraph> <paragraph> 5-40 mg q.d.*</paragraph>(%)</td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Betaxolol (N=73)</paragraph> <paragraph>40-160 mg b.i.d.</paragraph>(%)</td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Betaxolol</paragraph> <paragraph> (N=75)</paragraph> <paragraph>25-100 mg b.i.d.</paragraph>(%)</td> <td align="left" valign="top" styleCode="Lrule Botrule"> <paragraph>Placebo</paragraph> <paragraph>(N=109)</paragraph> <paragraph>(%)</paragraph> </td> </tr> <tr ID="id_337e764c-54b5-470d-949c-b787e87806cf"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Cardiovascular </paragraph> <paragraph> (heart rate &lt;50 BPM) </paragraph> <paragraph> Symptomatic bradycardia</paragraph> <paragraph> Edema</paragraph> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>8.1</paragraph> <paragraph>0.8</paragraph> <paragraph>1.8</paragraph> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph> 4.1</paragraph> <paragraph> 1.4</paragraph> <paragraph> 0</paragraph> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>12.0</paragraph> <paragraph> 0</paragraph> </td> <td align="left" valign="top" styleCode="Lrule Botrule"> <paragraph> 0</paragraph> <paragraph> 0</paragraph> </td> </tr> <tr ID="id_0377df35-906c-42e9-8cd2-1581b517aa47"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Central Nervous System</paragraph> <paragraph> Headache</paragraph> <paragraph> Dizziness</paragraph> <paragraph> Fatigue</paragraph> <paragraph> Lethargy</paragraph> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>6.5</paragraph> <paragraph>4.5</paragraph> <paragraph>2.9</paragraph> <paragraph>2.8</paragraph> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph> 4.1</paragraph> <paragraph>11.0</paragraph> <paragraph> 9.6</paragraph> <paragraph> 4.1</paragraph> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph> 5.3</paragraph> <paragraph> 2.7</paragraph> <paragraph> 4.0</paragraph> <paragraph> 2.7</paragraph> </td> <td align="left" valign="top" styleCode="Lrule Botrule"> <paragraph>15.6</paragraph> <paragraph> 5.5</paragraph> <paragraph> 0</paragraph> <paragraph> 0.9</paragraph> </td> </tr> <tr ID="id_86a76d95-f91c-45b3-a502-71f75db325c3"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Psychiatric</paragraph> <paragraph> Insomnia</paragraph> <paragraph> Nervousness</paragraph> <paragraph> Bizarre dreams</paragraph> <paragraph> Depression</paragraph> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>1.2</paragraph> <paragraph>0.8</paragraph> <paragraph>1.0</paragraph>0.8</td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph> 8.2</paragraph> <paragraph> 1.4</paragraph> <paragraph> 2.7</paragraph> 2.7</td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>2.7</paragraph> <paragraph>2.7</paragraph> <paragraph>1.3</paragraph> <paragraph>4.0</paragraph> </td> <td align="left" valign="top" styleCode="Lrule Botrule"> <paragraph> 0</paragraph> <paragraph> 0</paragraph> <paragraph> 0</paragraph> <paragraph> 0</paragraph> </td> </tr> <tr ID="id_09b49570-9060-4de5-879d-8eca2b04072f"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Autonomic</paragraph> <paragraph> Impotence</paragraph> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>1.2&#x2020;</paragraph> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph> 0</paragraph> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph> 0</paragraph> </td> <td align="left" valign="top" styleCode="Lrule Botrule"> <paragraph> 0</paragraph> </td> </tr> <tr ID="id_9031f2ad-b348-4dcb-9966-f2c44531c659"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Respiratory</paragraph> <paragraph> Dyspnea</paragraph> <paragraph> Pharyngitis</paragraph> <paragraph> Rhinitis</paragraph> Upper respiratory infection</td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>2.4</paragraph> <paragraph>2.0</paragraph> <paragraph>1.4</paragraph> <paragraph>2.6</paragraph> </td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>2.7</paragraph> <paragraph> 0</paragraph> <paragraph> 0</paragraph> 0</td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>1.3</paragraph> <paragraph>4.0</paragraph> <paragraph>4.0</paragraph> <paragraph>0</paragraph> </td> <td align="left" valign="top" styleCode="Lrule Botrule"> <paragraph>0.9</paragraph> <paragraph>0.9</paragraph> <paragraph>0.9</paragraph> <paragraph>5.5</paragraph> </td> </tr> <tr ID="id_cb23b825-b66c-4903-a3fe-9fe92d4d4f15"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Gastrointestinal</paragraph> <paragraph> Dyspepsia</paragraph> <paragraph> Nausea</paragraph> Diarrhea</td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>4.7</paragraph> <paragraph>1.6</paragraph>2.0</td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>6.8</paragraph> <paragraph>1.4</paragraph>6.8</td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>2.7</paragraph> <paragraph>4.0</paragraph>8.0</td> <td align="left" valign="top" styleCode="Lrule Botrule"> <paragraph>0.9</paragraph> <paragraph>0</paragraph>0.9</td> </tr> <tr ID="id_22bd9b0a-b95b-46a1-8153-e979354f1c86"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Musculoskeletal</paragraph> <paragraph> Chest pain</paragraph> Arthralgia</td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>2.4</paragraph>3.1</td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>1.4</paragraph> 0</td> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>2.7</paragraph>4.0</td> <td align="left" valign="top" styleCode="Lrule Botrule"> <paragraph>0.9</paragraph>1.8</td> </tr> <tr ID="id_e710a19d-8cef-452f-907d-3805e4edfe81"> <td align="left" valign="top" styleCode="Rrule"> <paragraph>Skin</paragraph> <paragraph> Rash</paragraph> </td> <td align="left" valign="top" styleCode="Rrule"> <paragraph>1.2</paragraph> </td> <td align="left" valign="top" styleCode="Rrule"> <paragraph> 0</paragraph> </td> <td align="left" valign="top" styleCode="Rrule"> <paragraph>0</paragraph> </td> <td align="left" valign="top" styleCode="Botrule"> <paragraph>0</paragraph> </td> </tr> </tbody> </table>

adverse reactions table

<table width="431" ID="id_ad63968d-c3fa-49b9-b281-448462e700a6"> <caption ID="id_8bc1cefb-27a9-495b-93e8-86732c77b757">Table 2 - European Controlled Hypertension Clinical Trials</caption> <col width="43.2%"/> <col width="23.0%"/> <col width="17.9%"/> <col width="16.0%"/> <tfoot ID="id_084a064a-99f1-4b30-a344-1863125bbf35"> <tr> <td align="left" valign="top" styleCode="Botrule" colspan="4">Adverse Events Reporting for Betaxolol, Atenolol and Placebo Patients</td> </tr> </tfoot> <tbody> <tr ID="id_e7089c5e-ac71-4432-9000-f8f615101ca0"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph> <content styleCode="bold">Dose Range</content> </paragraph> <content styleCode="bold">Body System/Adverse Reaction</content> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph> <content styleCode="bold">Betaxolol</content> </paragraph> <paragraph> <content styleCode="bold">(N=155)</content> </paragraph> <paragraph> <content styleCode="bold">20-40 mg q.d.</content> </paragraph> <paragraph> <content styleCode="bold">(%)</content> </paragraph> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph> <content styleCode="bold">Atenolol</content> </paragraph> <paragraph> <content styleCode="bold">(N=81)</content> </paragraph> <paragraph> <content styleCode="bold">100 mg q.d.</content> </paragraph> <paragraph> <content styleCode="bold">(%)</content> </paragraph> </td> <td align="center" valign="top" styleCode="Lrule Botrule"> <paragraph> <content styleCode="bold">Placebo</content> </paragraph> <paragraph> <content styleCode="bold">(N=60)</content> </paragraph> <paragraph> </paragraph> <paragraph> <content styleCode="bold">(%)</content> </paragraph> </td> </tr> <tr ID="id_3944267d-fbb9-4920-9701-3963cf2d7739"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Cardiovascular</paragraph> <paragraph> Bradycardia</paragraph> <paragraph> (heartrate &lt;50 BPM)</paragraph> <paragraph>Symptomatic bradycardia</paragraph> <paragraph>Palpitation</paragraph> <paragraph>Edema</paragraph> <paragraph>Cold extremities</paragraph> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>5.8</paragraph> <paragraph>1.9</paragraph> <paragraph>1.9</paragraph> <paragraph>1.3</paragraph> <paragraph>1.9</paragraph> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>5.0</paragraph> <paragraph>2.5</paragraph> <paragraph>3.7</paragraph> <paragraph>1.2</paragraph> <paragraph>0</paragraph> </td> <td align="center" valign="top" styleCode="Lrule Botrule"> <paragraph>0</paragraph> <paragraph>0</paragraph> <paragraph>1.7</paragraph> <paragraph>0</paragraph> <paragraph>0</paragraph> </td> </tr> <tr ID="id_dceb9c3e-f3f1-4ade-a63e-2acd363d7b2f"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Central Nervous System</paragraph> <paragraph> Headache</paragraph> <paragraph> Dizziness</paragraph> <paragraph> Fatigue</paragraph> <paragraph> Asthenia</paragraph> <paragraph> Insomnia</paragraph> <paragraph> Paresthesia</paragraph> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>14.8</paragraph> <paragraph>14.8</paragraph> <paragraph> 9.7</paragraph> <paragraph> 7.1</paragraph> <paragraph> 5.0</paragraph> <paragraph>.9</paragraph> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>9.9</paragraph> <paragraph>17.3</paragraph> <paragraph>18.5</paragraph> <paragraph> 0</paragraph> <paragraph> 3.7</paragraph> 2.5</td> <td align="center" valign="top" styleCode="Lrule Botrule"> <paragraph>23.3</paragraph> <paragraph>15.0</paragraph> <paragraph> 0</paragraph> <paragraph>16.7</paragraph> <paragraph> 3.3</paragraph> 0</td> </tr> <tr ID="id_39bd78e8-33ff-4479-b089-564f22250524"> <td align="left" valign="top" styleCode="Botrule Rrule"> <paragraph>Gastrointestinal</paragraph> <paragraph> Nausea</paragraph> <paragraph> Dyspepsia</paragraph> <paragraph> Diarrhea</paragraph> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph> 5.8 </paragraph> <paragraph> 3.9</paragraph> <paragraph> 1.9</paragraph> </td> <td align="center" valign="top" styleCode="Botrule Rrule"> <paragraph>1.2</paragraph> <paragraph>7.4</paragraph> <paragraph>3.7</paragraph> </td> <td align="center" valign="top" styleCode="Lrule Botrule"> <paragraph> 0</paragraph> <paragraph>3.3</paragraph> <paragraph> 0</paragraph> </td> </tr> <tr ID="id_7d593376-579d-49fa-8194-252e679ea958"> <td align="left" valign="top" styleCode="Rrule"> <paragraph>Musculoskeletal</paragraph> <paragraph> Chest pain</paragraph> <paragraph> Joint pain</paragraph> <paragraph> Myalgia</paragraph> </td> <td align="center" valign="top" styleCode="Rrule"> <paragraph>7.1</paragraph> <paragraph>5.2</paragraph> <paragraph>3.2</paragraph> </td> <td align="center" valign="top" styleCode="Rrule"> <paragraph>6.2</paragraph> <paragraph>4.9</paragraph> <paragraph>3.7</paragraph> </td> <td align="center" valign="top" styleCode="Botrule"> <paragraph>5.0</paragraph> <paragraph>1.7</paragraph> <paragraph>3.3</paragraph> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.