What are the possible side effects of Timoboil 0.5%?
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.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- swelling or redness of your eyelids;
- eye redness, discomfort, or sensitivity to light;
- drainage, crusting, or oozing of your eyes or eyelids;
- depressed mood, confusion, hallucinations, unusual thoughts or behavior;
- wheezing, gasping, or other breathing problems;
- swelling, rapid weight gain;
- chest pain, slow or uneven heart rate; or
- feeling short of breath, even with mild exertion.
Less serious side effects may include:
- blurred vision, double vision, drooping eyelid;
- burning or stinging in your eye;
- headache, weakness, drowsiness;
- numbness, tingling, or cold feeling in your hands or feet;
- ringing in your ears;
- dry mouth;
- nausea, diarrhea, loss of appetite, upset stomach;
- skin rash or worsening psoriasis;
- sleep problems (insomnia); or
- cough, stuffy nose.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Side effects of Timoboil 0.5% in details
Timoboil 0.5% tablets are usually well tolerated in properly selected patients. Most adverse effects have been mild and transient.
In a multi-center (12 week) clinical trial comparing Timoboil 0.5% and placebo in hypertensive patients, the following adverse reactions were reported spontaneously and considered to be causally related to Timoboil 0.5%:
| Timoboil 0.5% (n=176) % | Placebo (n=168) % | |
|---|---|---|
| BODY AS A WHOLE | ||
| fatigue/tiredness | 3.4 | 0.6 |
| headache | 1.7 | 1.8 |
| chest pain | 0.6 | 0 |
| asthenia | 0.6 | 0 |
| CARDIOVASCULAR | ||
| bradycardia | 9.1 | 0 |
| arrhythmia | 1.1 | 0.6 |
| syncope | 0.6 | 0 |
| edema | 0.6 | 1.2 |
| DIGESTIVE | ||
| dyspepsia | 0.6 | 0.6 |
| nausea | 0.6 | 0 |
| SKIN | ||
| pruritus | 1.1 | 0 |
| NERVOUS SYSTEM | ||
| dizziness | 2.3 | 1.2 |
| vertigo | 0.6 | 0 |
| paresthesia | 0.6 | 0 |
| PSYCHIATRIC | ||
| decreased libido | 0.6 | 0 |
| RESPIRATORY | ||
| dyspnea | 1.7 | 0.6 |
| bronchial spasm | 0.6 | 0 |
| rales | 0.6 | 0 |
| SPECIAL SENSES | ||
| eye irritation | 1.1 | 0.6 |
| tinnitus | 0.6 | 0 |
These data are representative of the incidence of adverse effects that may be observed in properly selected patients treated with Timoboil 0.5%, 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 Timoboil 0.5% and placebo groups were:
| Adverse Reaction* | Withdrawal† | |||
|---|---|---|---|---|
| Timoboil 0.5% (n=945) % | Placebo (n=939) % | Timoboil 0.5% (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 Timoboil 0.5% 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 Timoboil 0.5%, but reported with other beta-adrenergic blocking agents, should be considered potential adverse effects of Timoboil 0.5%. 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 Timoboil 0.5%.
Clinical Laboratory Test Findings
Clinically important changes in standard laboratory parameters were rarely associated with the administration of Timoboil 0.5%. 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.
What is the most important information I should know about Timoboil 0.5%?
- Timoboil 0.5% may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Timoboil 0.5% with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Additional monitoring of your dose or condition may be needed if you are taking prazosin.
- Tell your doctor or dentist that you take Timoboil 0.5% before you receive any medical or dental care, emergency care, or surgery.
- If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
- Diabetes patients - Timoboil 0.5% may hide signs of low blood sugar, such as a rapid heartbeat. Be sure to watch for other signs of low blood sugar. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your vision change; give you a headache, chills, or tremors; or make you more hungry. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
- If your doctor has instructed you to check your blood pressure and heart rate regularly, be sure to do so.
- Timoboil 0.5% should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Timoboil 0.5% while you are pregnant. Timoboil 0.5% is found in breast milk. Do not breast-feed while taking Timoboil 0.5%.
Timoboil 0.5% contraindications
Hypersensitivity to Timoboil 0.5% or any component of the formulation; sinus bradycardia; heart block greater than first degree (except in patients with a functioning artificial pacemaker); cardiogenic shock; uncompensated cardiac failure; bronchospastic disease
Documentation of allergenic cross-reactivity for beta-blockers is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Canadian labeling: Additional contraindications (not in US labeling): Right ventricular failure secondary to pulmonary hypertension; significant cardiomegaly; allergic rhinitis; severe chronic obstructive pulmonary disease; anesthesia with agents that produce myocardial depression (eg, ether hypersensitivity to Timoboil 0.5%)
References
- DailyMed. "TIMOLOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "(S)-1-(tert-butylamino)-3-[(4-morpholino-1,2,5-thiadiazol-3-yl)oxy]propan-2-ol: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
- HSDB. "TIMOLOL". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Timoboil 0.5% are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Timoboil 0.5%. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
