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Blocadren Side Effects Center
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Blocadren in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side effects:
- slow or uneven heartbeats;
- feeling light-headed, fainting;
- feeling short of breath, even with mild exertion;
- swelling of your ankles or feet;
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- depression; or
- cold feeling in your hands and feet.
Other less serious side effects are more likely to occur, such as:
- decreased sex drive, impotence, or difficulty having an orgasm;
- sleep problems (insomnia);
- tired feeling; or
- anxiety, nervousness.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Blocadren (Timolol) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Blocadren FDA Prescribing Information: Side Effects
BLOCADREN (timolol) 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:
(n = 176)
(n = 168)
|BODY AS A WHOLE|
These data are representative of the incidence of adverse effects that may be observed in properly selected patients treated with BLOCADREN (timolol) , 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 (see CLINICAL PHARMACOLOGY), 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
|Asthenia or Fatigue||5||1||<1||<1|
|Heart Rate <40 beats/minute||5||<1||4||<1|
|AV Block - 2nd or 3rd degree||<1||<1||<1||<1|
|Cold Hands and Feet||8||<1||<1||0|
|Nausea or Digestive Disorders||8||6||1||<1|
|*** When an adverse reaction recurred in
a patient, it is listed only once.
†Only principal reason for withdrawal in each patient is listed. These adverse reactions can also occur in patients treated for hypertension.
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 (timolol) , but reported with other beta-adrenergic blocking agents, should be considered potential adverse effects of BLOCADREN (timolol) : 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 (see CONTRAINDICATIONS); 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 (timolol) .
Clinical Laboratory Test Findings: Clinically important changes in standard laboratory parameters were rarely associated with the administration of BLOCADREN (timolol) . 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.
Read the entire FDA prescribing information for Blocadren (Timolol) »
Additional Blocadren Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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