Blocadren Side Effects
Generic Name: timolol
Please note - some side effects for Blocadren 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).
Side Effects of Blocadren - for the Consumer
Blocadren
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Blocadren:
Seek medical attention right away if any of these SEVERE side effects occur when using Blocadren:Dizziness; fatigue/tiredness; lightheadedness; mild drowsiness; slow heartbeat; unusual weakness.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breathing problems; chest pain; irregular heart rhythms.
Blocadren Side Effects - for the Professional
Blocadren
Blocadren is usually well tolerated in properly selected patients. Most adverse effects have been mild and transient.
In a multicenter (12-week) clinical trial comparing timolol maleate and placebo in hypertensive patients, the following adverse reactions were reported spontaneously and considered to be causally related to timolol maleate:
Timolol Maleate (n = 176) % |
Placebo (n = 168) % |
|
| BODY AS A WHOLE fatigue/tiredness headache chest pain asthenia |
3.4 1.7 0.6 0.6 |
0.6 1.8 0 0 |
| CARDIOVASCULAR bradycardia arrhythmia syncope edema |
9.1 1.1 0.6 0.6 |
0 0.6 0 1.2 |
| DIGESTIVE dyspepsia nausea |
0.6 0.6 |
0.6 0 |
| SKIN pruritus |
1.1 |
0 |
| NERVOUS SYSTEM dizziness vertigo paresthesia |
2.3 0.6 0.6 |
1.2 0 0 |
| PSYCHIATRIC decreased libido |
0.6 |
0 |
| RESPIRATORY dyspnea bronchial spasm rales |
1.7 0.6 0.6 |
0.6 0 0 |
| SPECIAL SENSES eye irritation tinnitus |
1.1 0.6 |
0.6 0 |
These data are representative of the incidence of adverse effects that may be observed in properly selected patients treated with Blocadren, i.e., excluding patients with bronchospastic disease, congestive heart failure or other contraindications to beta blocker therapy.
In patients with migraine the incidence of bradycardia was 5 percent.
In a coronary artery disease population studied in the Norwegian multi-center trial, the frequency of the principal adverse reactions and the frequency with which these resulted in discontinuation of therapy in the timolol and placebo groups were:
| Adverse Reaction* | Withdrawal† | |||
| Timolol (n=945) % |
Placebo (n=939) % |
Timolol (n=945) % |
Placebo (n=939) % |
|
| Asthenia or Fatigue | 5 | 1 | <1 | <1 |
| Heart Rate <40 beats/minute | 5 | <1 | 4 | <1 |
| Cardiac Failure-Nonfatal | 8 | 7 | 3 | 2 |
| Hypotension | 3 | 2 | 3 | 1 |
| Pulmonary Edema-Nonfatal | 2 | <1 | <1 | <1 |
| Claudication | 3 | 3 | 1 | <1 |
| AV Block - 2nd or 3rd degree | <1 | <1 | <1 | <1 |
| Sinoatrial Block | <1 | <1 | <1 | <1 |
| Cold Hands and Feet | 8 | <1 | <1 | 0 |
| Nausea or Digestive Disorders | 8 | 6 | 1 | <1 |
| Dizziness | 6 | 4 | 1 | 0 |
| Bronchial Obstruction | 2 | <1 | 1 | <1 |
The following additional adverse effects have been reported in clinical experience with the drug: Body as a Whole: anaphylaxis,extremity pain, decreased exercise tolerance, weight loss, fever; Cardiovascular: cardiac arrest, cardiac failure, cerebral vascular accident, worsening of angina pectoris, worsening of arterial insufficiency, Raynaud's phenomenon, palpitations, vasodilatation; Digestive: gastrointestinal pain, hepatomegaly, vomiting, diarrhea, dyspepsia; Hematologic:nonthrombocytopenic purpura; Endocrine: hyperglycemia, hypoglycemia; Skin:rash, skin irritation, increased pigmentation, sweating, alopecia; Musculoskeletal: arthralgia; Nervous System: local weakness, increase in signs and symptoms of myasthenia gravis; Psychiatric: depression, nightmares, somnolence, insomnia, nervousness, diminished concentration, hallucinations; Respiratory: cough; Special Senses: visual disturbances, diplopia, ptosis, dry eyes; Urogenital: impotence, urination difficulties.
There have been reports of retroperitoneal fibrosis in patients receiving timolol maleate and in patients receiving other beta-adrenergic blocking agents. A causal relationship between this condition and therapy with beta-adrenergic blocking agents has not been established.
Potential Adverse Effects: In addition, a variety of adverse effects not observed in clinical trials with Blocadren, but reported with other beta-adrenergic blocking agents, should be considered potential adverse effects of Blocadren: 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, slightly clouded sensorium, and decreased performance on neuropsychometrics; Cardiovascular:Intensification of AV block; Digestive: Mesenteric arterial thrombosis, ischemic colitis; Hematologic: Agranulocytosis, thrombocytopenic purpura; Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Miscellaneous: Peyronie's disease.
There have been reports of a syndrome comprising psoriasiform skin rash, conjunctivitis sicca, otitis, and sclerosing serositis attributed to the beta-adrenergic receptor blocking agent, practolol. This syndrome has not been reported with Blocadren.
Clinical Laboratory Test Findings: Clinically important changes in standard laboratory parameters were rarely associated with the administration of Blocadren. Slight increases in blood urea nitrogen, serum potassium, uric acid, and triglycerides, and slight decreases in hemoglobin, hematocrit and HDL cholesterol occurred, but were not progressive or associated with clinical manifestations. Increases in liver function tests have been reported.
TopSide Effects by Body System
Cardiovascular
Cardiovascular side effects are the most common. Sinus bradycardia is reported in 9% of patients. Atrioventricular conduction disturbances, hypotension, and exacerbation of congestive heart failure are reported in less than 1% of patients.
Respiratory
Respiratory problems associated with timolol, like with other beta antagonists, include bronchial constriction in susceptible patients. Dyspnea is reported in 6% of patients.
Alternative therapy should be considered in patients with reactive airways disease. Cases of fatal respiratory arrest are reported in patients with asthma, even after topically administered timolol.
Nervous system
Nervous system side effects include fatigue in 6%, headache in 4%, and dizziness in 6% of treated patients. Cases of visual hallucinations, insomnia and depression have been reported rarely. Timolol may worsen myasthenia gravis.
A case of amaurosis fugax is associated with timolol. However, the patient involved had underlying cerebrovascular disease, autonomic dysfunction, and an arrhythmia.
Endocrine
Endocrinologic side effects of timolol include masking the signs and symptoms and blunting the normal physiologic response to hypoglycemia. Timolol may cause an increase in serum triglycerides, LDL cholesterol, and VLDL cholesterol, and a decrease in HDL cholesterol.
Alternative therapy should be considered in patients with diabetes mellitus who are prone to hypoglycemia.
Psychiatric
Psychiatric side effects, such as confusion, depression (including acute suicidal ideation), vivid and frightening dreams, and visual hallucinations are reported in rare cases.
Sexual dysfunction is reported from questionnaires, although the questions may have biased the data since the responses were not spontaneous.
Gastrointestinal
Gastrointestinal complaints of general abdominal pain, nausea, constipation, or diarrhea are reported in 1% to 5% of patients.
Dermatologic
Dermatologic side effects are unusual. Rare cases of generalized psoriasis and hyperpigmented nailbeds are reported.
Genitourinary
Genitourinary complaints of impotence and decreased libido are rare.
Musculoskeletal
Musculoskeletal side effects are rare. Timolol may worsen myasthenia gravis.
General
General side effects including decreased exercise tolerance, extremity pain, weight loss and fever have been reported.
Hypersensitivity
Hypersensitivity reactions including anaphylaxis have been reported in clinical experience with timolol.
TopMore resources:
Blocadren - Includes detailed dosage instructions.
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