|
|
| Line 1: |
Line 1: |
| __NOTOC__
| | #REDIRECT [[Bisoprolol#Adverse Reactions]] |
| {{Bisoprolol }}
| |
| {{CMG}}; {{AE}} {{SS}}
| |
| | |
| ==Adverse Reactions==
| |
| Safety data are available in more than 30,000 patients or volunteers. Frequency estimates and rates of withdrawal of therapy for adverse events were derived from two U.S. placebo-controlled studies.
| |
| | |
| In Study A, doses of 5, 10, and 20 mg bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5, 10, and 40 mg of bisoprolol fumarate were administered for 12 weeks. A total of 273 patients were treated with 5-20 mg of bisoprolol fumarate; 132 received placebo.
| |
| | |
| Withdrawal of therapy for adverse events was 3.3% for patients receiving bisoprolol fumarate and 6.8% for patients on placebo. Withdrawals were less than 1% for either bradycardia or fatigue/lack of energy.
| |
| | |
| The following table presents adverse experiences, whether or not considered drug related, reported in at least 1% of patients in these studies, for all patients studied in placebo-controlled clinical trials (2.5-40 mg), as well as for a subgroup that was treated with doses within the recommended dosage range (5-20 mg). Of the adverse events listed in the table, [[bradycardia]], [[diarrhea]], [[asthenia]], fatigue, and [[sinusitis]] appear to be dose related.
| |
| {|
| |
| |-
| |
| |[[File:Bisoprolol01.jpg|thumb|800px]]
| |
| |-
| |
| |}
| |
| | |
| The following is a comprehensive list of adverse experiences reported with bisoprolol fumarate in worldwide studies, or in postmarketing experience (in italics):
| |
| | |
| ===Central Nervous System===
| |
| | |
| [[Dizziness]], [[unsteadiness]], [[vertigo]], [[syncope]], [[headache]], [[paresthesia]], [[hypoesthesia]], [[hyperesthesia]], [[somnolence]], [[sleep disturbances]], [[anxiety]]/restlessness, decreased concentration/memory.
| |
| | |
| ===Autonomic Nervous System===
| |
| | |
| Dry mouth.
| |
| | |
| ===Cardiovascular===
| |
| | |
| [[Bradycardia]], [[palpitations]] and other [[rhythm disturbances]], cold extremities, [[claudication]], [[hypotension]], [[orthostatic hypotension]], [[chest pain]], congestive heart failure, [[dyspnea]] on exertion.
| |
| | |
| ===Psychiatric===
| |
| | |
| Vivid dreams, [[insomnia]], [[depression]].Ŗ
| |
| | |
| ===Gastrointestinal===
| |
| | |
| Gastric/epigastric/abdominal pain, [[gastritis]], [[dyspepsia]], [[nausea]], vomiting, diarrhea, [[constipation]], [[peptic ulcer]].
| |
| | |
| ===Musculoskeletal===
| |
| | |
| Muscle/joint pain, [[arthralgia]], back/neck pain, [[muscle cramp]]s, twitching/tremor.
| |
| | |
| ===Skin===
| |
| | |
| [[Rash]], [[acne]], [[eczema]], [[psoriasis]], [[skin irritation]], [[pruritus]], [[flushing]], sweating, [[alopecia]], [[dermatitis]], [[angioedema]], [[exfoliative dermatitis]], [[cutaneous vasculitis]].
| |
| | |
| ===Special Senses===
| |
| | |
| Visual disturbances, ocular pain/pressure, abnormal lacrimation, tinnitus, decreased hearing, earache, taste abnormalities.
| |
| | |
| ===Metabolic===
| |
| | |
| [[Gout]].
| |
| | |
| ===Respiratory===
| |
| | |
| Asthma/bronchospasm, [[bronchitis]], [[coughing]], [[dyspnea]], [[pharyngitis]], [[rhinitis]], [[sinusitis]], URI.
| |
| | |
| ===Genitourinary===
| |
| | |
| Decreased libido/impotence, [[Peyronie’s disease]], [[cystitis]], [[renal colic]], [[polyuria]].
| |
| | |
| ===Hematologic===
| |
| | |
| [[Purpura]].
| |
| | |
| ===General===
| |
| | |
| Fatigue, [[asthenia]], [[chest pain]] malaise, [[edema]], weight gain, [[angioedema]].
| |
| | |
| In addition, a variety of adverse effects have been reported with other beta-adrenergic blocking agents and should be considered potential adverse effects of ZEBETA:
| |
| | |
| ===Central Nervous System===
| |
| | |
| Reversible mental depression progressing to [[catatonia]], [[hallucinations]], an acute reversible syndrome characterized by disorientation to time and place, emotional lability, slightly clouded sensorium.
| |
| | |
| ===Allergic===
| |
| | |
| [[Fever]], combined with aching and sore throat, [[laryngospasm]], [[respiratory distress]].
| |
| | |
| ===Hematologic===
| |
| | |
| [[Agranulocytosis]], [[thrombocytopenia]], [[thrombocytopenic purpura]].
| |
| | |
| ===Gastrointestinal===
| |
| | |
| Mesenteric arterial [[thrombosis]], [[ischemic colitis]].
| |
| | |
| ===Miscellaneous===
| |
| | |
| The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with ZEBETA (bisoprolol fumarate) during investigational use or extensive foreign marketing experience.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = ZEBETA (BISOPROLOL FUMARATE) TABLET [DURAMED PHARMACEUTICALS, INC.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a11548a0-9c0f-4729-907c-75d8f99a6c85 | publisher = | date = | accessdate = 4 February 2014 }}</ref>
| |
| | |
| | |
| | |
| | |
| ==References==
| |
| | |
| {{Reflist|2}}
| |
|
| |
|
| [[Category:Beta blockers]] | | [[Category:Beta blockers]] |
| [[Category:Cardiovascular Drugs]] | | [[Category:Cardiovascular Drugs]] |
| [[Category:Drugs]] | | [[Category:Drugs]] |
| {{WikiDoc Help Menu}}
| |
| {{WikiDoc Sources}}
| |