Visken Side Effects
Generic Name: Pindolol
Please note - some side effects for Visken may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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Visken
Most adverse reactions have been mild. The incidences listed in the following table are derived from 12-week comparative double-blind, parallel design trials in hypertensive patients given Visken® (pindolol) as monotherapy, given various active control drugs as monotherapy, or given placebo. Data for Visken® (pindolol) and the positive controls were pooled from several trials because no striking differences were seen in the individual studies, with 1 exception. When considering all adverse reactions reported, the frequency of edema was noticeably higher in positive control trials [16% Visken® (pindolol) vs. 9% positive control] than in placebo controlled trials [6%Visken® (pindolol) vs. 3% placebo]. The table includes adverse reactions either volunteered or elicited, and at least possibly drug related, which were reported in greater than 2% of Visken® (pindolol) patients and other selected important reactions.
|
Body System/ Adverse Reactions |
Visken® (pindolol) (N=322) % |
Active Controls* (N=188) % |
Placebo (N=78) % |
| Central Nervous System | |||
| Bizarre or Many Dreams | 5 | 0 | 6 |
| Dizziness | 9 | 11 | 1 |
| Fatigue | 8 | 4 | 4 |
| Hallucinations | <1 | 0 | 0 |
| Insomnia | 10 | 3 | 10 |
| Nervousness | 7 | 3 | 5 |
| Weakness | 4 | 2 | 1 |
| Autonomic Nervous System | |||
| Paresthesia | 3 | 1 | 6 |
| Cardiovascular | |||
| Dyspnea | 5 | 4 | 6 |
| Edema | 6 | 3 | 1 |
| Heart Failure | <1 | <1 | 0 |
| Palpitations | <1 | 1 | 0 |
| Musculoskeletal | |||
| Chest Pain | 3 | 1 | 3 |
| Joint Pain | 7 | 4 | 4 |
| Muscle Cramps | 3 | 1 | 0 |
| Muscle Pain | 10 | 9 | 8 |
| Gastrointestinal | |||
| Abdominal Discomfort | 4 | 4 | 5 |
| Nausea | 5 | 2 | 1 |
| Skin | |||
| Pruritus | 1 | <1 | 0 |
| Rash | <1 | <1 | 1 |
*Active Controls: Patients received either propranolol, α-methyldopa or a diuretic (hydrochlorothiazide or chlorthalidone).
The following selected (potentially important) adverse reactions were seen in 2% or fewer patients and their relationship to Visken® (pindolol) is uncertain. CENTRAL NERVOUS SYSTEM: anxiety, lethargy; AUTONOMIC NERVOUS SYSTEM: visual disturbances, hyperhidrosis; CARDIOVASCULAR: bradycardia, claudication, cold extremities, heart block, hypotension, syncope, tachycardia, weight gain; GASTROINTESTINAL: diarrhea, vomiting; RESPIRATORY: wheezing; UROGENITAL: impotence, pollakiuria; MISCELLANEOUS: eye discomfort or burning eyes.
TopMore resources:
Visken - Includes detailed dosage instructions.
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