Timolol Maleate

openFDA label record#

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Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Timolol Maleate
Generic name
TIMOLOL MALEATE
Manufacturer
Rising Pharma Holdings, Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
0bc40b2c-65eb-4095-87e6-4752d5b19a3a
SPL ID
ebb620d8-8e2e-4632-b8a8-74f41c9969e6
Version
1
Effective date
2024-06-11
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:24:37
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 2 matching rows.

warnings

WARNINGS Cardiac Failure Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure. Although beta-blockers should be avoided in overt congestive heart failure, they can be used, if necessary, with caution in patients with a history of failure who are well compensated, usually with digitalis and diuretics. Both digitalis and timolol maleate slow AV conduction. If cardiac failure persists, therapy with timolol maleate should be withdrawn. In Patients Without a History of Cardiac Failure Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, patients receiving timolol should be digitalized and/or be given a diuretic, and the response observed closely. If cardiac failure continues, despite adequate digitalization and diuretic therapy, timolol should be withdrawn. Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after abrupt discontinuation of such therapy. When discontinuing chronically administered timolol maleate, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of one to two weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, timolol maleate administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue timolol maleate therapy abruptly even in patients treated only for hypertension. Obstructive Pulmonary Disease PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (e.g., CHRONIC BRONCHITIS, EMPHYSEMA) OF MILD OR MODERATE SEVERITY, BRONCHOSPASTIC DISEASE OR A HISTORY OF BRONCHOSPASTIC DISEASE (OTHER THAN BRONCHIAL ASTHMA OR A HISTORY OF BRONCHIAL ASTHMA, IN WHICH 'TIMOLOL MALEATE' IS CONTRAINDICATED, see CONTRAINDICATIONS), SHOULD IN GENERAL NOT RECEIVE BETA-BLOCKERS, INCLUDING 'TIMOLOL'. However, if timolol is necessary in such patients, then the drug should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta 2 receptors. Major Surgery The necessity or desirability of withdrawal of beta-blocking therapy prior to major surgery is controversial. Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have been subject to protracted severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been reported. For these reasons, in patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or norepinephrine (see OVERDOSAGE). Diabetes Mellitus Timolol should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia. Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-blockade which might precipitate a thyroid storm.

warnings table

<table width="100%"><caption/><tbody><tr styleCode="First Last"><td><paragraph>Exacerbation of Ischemic Heart Disease Following Abrupt Withdrawal</paragraph><paragraph> Hypersensitivity to catecholamines has been observed in patients withdrawn from beta-blocker therapy; exacerbation of angina and, in some cases, myocardial infarction have occurred after <content styleCode="italics">abrupt</content> discontinuation of such therapy. When discontinuing chronically administered timolol maleate, particularly in patients with ischemic heart disease, the dosage should be gradually reduced over a period of one to two weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, timolol maleate administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician&apos;s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue timolol maleate therapy abruptly even in patients treated only for hypertension.</paragraph></td></tr></tbody></table>

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 3 matching rows.

adverse reactions

ADVERSE REACTIONS Timolol maleate 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 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 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 timolol maleate, 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: 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 *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 timolol maleate, but reported with other beta-adrenergic blocking agents, should be considered potential adverse effects of 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 timolol. Clinical Laboratory Test Findings Clinically important changes in standard laboratory parameters were rarely associated with the administration of 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. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda. gov/medwatch .

adverse reactions table

<table width="682px"><thead><tr styleCode="First Last"><td valign="top"/><td valign="top"><paragraph><content styleCode="bold">Timolol Maleate </content> <content styleCode="bold"> (n=176) </content> <content styleCode="bold"><content styleCode="underline">%</content></content></paragraph></td><td valign="top"><paragraph><content styleCode="bold">Placebo </content> <content styleCode="bold"> (n=168) </content> <content styleCode="bold"><content styleCode="underline">%</content></content></paragraph></td></tr></thead><tbody><tr><td><paragraph>BODY AS A WHOLE</paragraph></td><td/><td/></tr><tr><td><paragraph> fatigue/tiredness</paragraph></td><td><paragraph>3.4</paragraph></td><td><paragraph>0.6</paragraph></td></tr><tr><td><paragraph> headache</paragraph></td><td><paragraph>1.7</paragraph></td><td><paragraph>1.8</paragraph></td></tr><tr><td><paragraph> chest pain</paragraph></td><td><paragraph>0.6</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph> asthenia</paragraph></td><td><paragraph>0.6</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph>CARDIOVASCULAR</paragraph></td><td/><td/></tr><tr><td><paragraph> bradycardia</paragraph></td><td><paragraph>9.1</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph> arrhythmia</paragraph></td><td><paragraph>1.1</paragraph></td><td><paragraph>0.6</paragraph></td></tr><tr><td><paragraph> syncope</paragraph></td><td><paragraph>0.6</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph> edema</paragraph></td><td><paragraph>0.6</paragraph></td><td><paragraph>1.2</paragraph></td></tr><tr><td><paragraph>DIGESTIVE</paragraph></td><td/><td/></tr><tr><td><paragraph> dyspepsia</paragraph></td><td><paragraph>0.6</paragraph></td><td><paragraph>0.6</paragraph></td></tr><tr><td><paragraph> nausea</paragraph></td><td><paragraph>0.6</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph>SKIN</paragraph></td><td/><td/></tr><tr><td><paragraph> pruritus</paragraph></td><td><paragraph>1.1</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph>NERVOUS SYSTEM</paragraph></td><td/><td/></tr><tr><td><paragraph> dizziness</paragraph></td><td><paragraph>2.3</paragraph></td><td><paragraph>1.2</paragraph></td></tr><tr><td><paragraph> vertigo</paragraph></td><td><paragraph>0.6</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph> paresthesia</paragraph></td><td><paragraph>0.6</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph>PSYCHIATRIC</paragraph></td><td/><td/></tr><tr><td><paragraph> decreased libido</paragraph></td><td><paragraph>0.6</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph>RESPIRATORY</paragraph></td><td/><td/></tr><tr><td><paragraph> dyspnea</paragraph></td><td><paragraph>1.7</paragraph></td><td><paragraph>0.6</paragraph></td></tr><tr><td><paragraph> bronchial spasm</paragraph></td><td><paragraph>0.6</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph> rales</paragraph></td><td><paragraph>0.6</paragraph></td><td><paragraph>0</paragraph></td></tr><tr><td><paragraph>SPECIAL SENSES</paragraph></td><td/><td/></tr><tr><td><paragraph> eye irritation</paragraph></td><td><paragraph>1.1</paragraph></td><td><paragraph>0.6</paragraph></td></tr><tr><td><paragraph> tinnitus</paragraph></td><td><paragraph>0.6</paragraph></td><td><paragraph>0</paragraph></td></tr></tbody></table>

adverse reactions table

<table width="640px"><thead><tr><td valign="top"/><td colspan="2" valign="top"><paragraph><content styleCode="bold">Adverse Reaction*</content></paragraph></td><td colspan="2" valign="top"><paragraph><content styleCode="bold">Withdrawal<sup>&#x2020;</sup></content></paragraph></td></tr><tr><td valign="top"/><td valign="top"><paragraph><content styleCode="bold">Timolol </content> <content styleCode="bold"> (n=945) </content> <content styleCode="bold"><content styleCode="underline">%</content></content></paragraph></td><td valign="top"><paragraph><content styleCode="bold">Placebo </content> <content styleCode="bold"> (n=939) </content> <content styleCode="bold"><content styleCode="underline">%</content></content></paragraph></td><td valign="top"><paragraph><content styleCode="bold">Timolol (n=945) <content styleCode="underline">%</content></content></paragraph></td><td align="center" valign="top"><content styleCode="bold">Placebo </content> <content styleCode="bold">(n=939) </content> <content styleCode="bold"><content styleCode="underline">%</content></content></td><td valign="top"/><td valign="top"/></tr></thead><tbody><tr><td/></tr><tr><td><paragraph>Asthenia or Fatigue</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>1</paragraph></td><td><paragraph>&lt;1</paragraph></td><td>&lt;1</td><td/><td/></tr><tr><td><paragraph>Heart Rate &lt; 40 beats/minute</paragraph></td><td><paragraph>5</paragraph></td><td><paragraph>&lt;1</paragraph></td><td><paragraph>4</paragraph></td><td>&lt;1</td><td/><td/></tr><tr><td><paragraph>Cardiac Failure-Nonfatal</paragraph></td><td><paragraph>8</paragraph></td><td><paragraph>7</paragraph></td><td><paragraph>3</paragraph></td><td>2</td><td/><td/></tr><tr><td><paragraph>Hypotension</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>3</paragraph></td><td>1</td><td/><td/></tr><tr><td><paragraph>Pulmonary Edema-Nonfatal</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>&lt;1</paragraph></td><td><paragraph>&lt;1</paragraph></td><td>&lt;1</td><td/><td/></tr><tr><td><paragraph>Claudication</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>3</paragraph></td><td><paragraph>1</paragraph></td><td>&lt;1</td><td/><td/></tr><tr><td><paragraph>AV Block 2nd or 3rd Degree</paragraph></td><td><paragraph>&lt;1</paragraph></td><td><paragraph>&lt;1</paragraph></td><td><paragraph>&lt;1</paragraph></td><td>&lt;1</td><td/><td/></tr><tr><td><paragraph>Sinoatrial Block</paragraph></td><td><paragraph>&lt;1</paragraph></td><td><paragraph>&lt;1</paragraph></td><td><paragraph>&lt;1</paragraph></td><td>&lt;1</td><td/><td/></tr><tr><td><paragraph>Cold Hands and Feet</paragraph></td><td><paragraph>8</paragraph></td><td><paragraph>&lt;1</paragraph></td><td><paragraph>&lt;1</paragraph></td><td>0</td><td/><td/></tr><tr><td><paragraph>Nausea or Digestive Disorders</paragraph></td><td><paragraph>8</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>1</paragraph></td><td>&lt;1</td><td/><td/></tr><tr><td><paragraph>Dizziness</paragraph></td><td><paragraph>6</paragraph></td><td><paragraph>4</paragraph></td><td><paragraph>1</paragraph></td><td>0</td><td/><td/></tr><tr><td><paragraph>Bronchial Obstruction</paragraph></td><td><paragraph>2</paragraph></td><td><paragraph>&lt;1</paragraph></td><td><paragraph>1</paragraph></td><td>&lt;1</td><td/><td/></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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