February 22, 2017
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Cosopt

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Cosopt




Cosopt Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 11/02/2016

Cosopt (dorzolamide hydrochloride-timolol maleate) is a combination of a carbonic anhydrase inhibitor and a beta-blocker that reduces pressure in the eye and is used to treat certain types of glaucoma and other causes of high pressure inside the eye. Cosopt is available in generic form. Common side effects of Cosopt include:

  • temporary blurred vision,
  • cloudy vision,
  • double vision,
  • temporary burning/stinging/itching/redness of the eye,
  • watery eyes,
  • dry eyes,
  • feeling as if something is in the eye,
  • drooping eyelid,
  • sensitivity of eyes to light,
  • bitter or strange taste in the mouth,
  • cough,
  • flu symptoms,
  • nausea,
  • upset stomach,
  • stomach pain,
  • back pain,
  • sore throat,
  • stuffy nose,
  • headache, or
  • drowsiness.

Tell your doctor if you have unlikely but serious side effects of Cosopt including:

  • dizziness,
  • slow or irregular heartbeat,
  • muscle weakness,
  • mental/mood changes, or
  • coldness/numbness/pain in the hands or feet.

The dose is one drop of Cosopt ophthalmic solution in the affected eye(s) two times daily. If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart. Cosopt may interact with clonidine, quinidine, reserpine, digitalis, acetazolamide or methazolamide, beta-blockers, calcium channel blockers, or antidepressants. Tell your doctor all medications you use. Cosopt should be used only when prescribed during pregnancy. This drug passes into breast milk. Consult your doctor before breastfeeding.

Our Cosopt (dorzolamide hydrochloride-timolol maleate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Cosopt 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.

Although the risk of serious side effects is low when dorzolamide and timolol is used in the eyes, you should be aware of side effects that can occur if the medication is absorbed into your bloodstream.

Stop using dorzolamide ophthalmic and call your doctor at once if you have a serious side effect such as:

  • swelling or redness of your eyelids;
  • eye redness, pain, discomfort, or sensitivity to light;
  • drainage, crusting, or oozing of your eyes or eyelids;
  • wheezing, gasping, or other breathing problems;
  • swelling, rapid weight gain;
  • feeling short of breath, even with mild exertion; or
  • severe skin reaction: fever, sore throat, cough, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • blurred vision, cloudy vision, double vision, drooping eyelid;
  • dry or watery eyes;
  • bitter or unusual taste in your mouth;
  • burning, stinging, or itching in your eyes;
  • cough, flu symptoms;
  • dry eyes;
  • nausea, upset stomach;
  • sore throat, stuffy nose;
  • dizziness, headache; or
  • stomach or back pain.

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.

Read the entire detailed patient monograph for Cosopt (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cosopt Overview - Patient Information: Side Effects

SIDE EFFECTS: Temporary blurred vision, temporary burning/stinging/itching/redness of the eye, watery eyes, dry eyes, feeling as if something is in the eye, sensitivity of eyes to light, strange taste in the mouth, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: dizziness, slow/irregular heartbeat, muscle weakness, mental/mood changes, coldness/numbness/pain in the hands or feet.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes, signs of a kidney stone (e.g., pain in the back/side/abdomen, nausea/vomiting, blood in the urine), yellowing eyes or skin, dark urine, unusual tiredness/weakness, easy bruising/bleeding, signs of infection (e.g., fever, chills, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious side effects occur: persistent eye redness or discharge, eye or eyelid swelling, eye pain, trouble breathing, sudden unexplained weight gain, chest pain, weakness on one side of the body, slurred speech, confusion, persistent dizziness, fainting.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Cosopt (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cosopt FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

COSOPT was evaluated in 1035 patients with elevated intraocular pressure treated for open-angle glaucoma or ocular hypertension for up to 15 months. Approximately 5% of all patients discontinued therapy because of adverse reactions.

The most frequently reported adverse reactions occurring in up to 30% of patients were taste perversion (bitter, sour, or unusual taste) or ocular burning and/or stinging. The following adverse reactions were reported in 5 to15% of patients: conjunctival hyperemia, blurred vision, superficial punctate keratitis or eye itching.

The following adverse reactions were reported in 1 to 5% of patients: abdominal pain, back pain, blepharitis, bronchitis, cloudy vision, conjunctival discharge, conjunctival edema, conjunctival follicles, conjunctival injection, conjunctivitis, corneal erosion, corneal staining, cortical lens opacity, cough, dizziness, dryness of eyes, dyspepsia, eye debris, eye discharge, eye pain, eye tearing, eyelid edema, eyelid erythema, eyelid exudate/scales, eyelid pain or discomfort, foreign body sensation, glaucomatous cupping, headache, hypertension, influenza, lens nucleus coloration, lens opacity, nausea, nuclear lens opacity, pharyngitis, post-subcapsular cataract, sinusitis, upper respiratory infection, urinary tract infection, visual field defect, vitreous detachment.

Other adverse reactions that have been reported with the individual components are listed below:

Dorzolamide 2%

Angioedema, asthenia/fatigue, bronchospasm, contact dermatitis, epistaxis, eyelid crusting, ocular discomfort, photophobia, signs and symptoms of ocular allergic reaction, transient myopia.

Timolol (ocular administration)

Body as a Whole: Asthenia/fatigue; Cardiovascular: Arrhythmia, syncope, cerebral ischemia, worsening of angina pectoris, palpitation, cardiac arrest, pulmonary edema, edema, claudication, Raynaud's phenomenon, and cold hands and feet; Digestive: Anorexia, abdominal pain; Immunologic: Systemic lupus erythematosus; Nervous System/Psychiatric: Increase in signs and symptoms of myasthenia gravis, somnolence, insomnia, nightmares, behavioral changes and psychic disturbances including confusion, hallucinations, anxiety, disorientation, nervousness, and memory loss; Skin: Alopecia, psoriasiform rash or exacerbation of psoriasis; Hypersensitivity: Signs and symptoms of systemic allergic reactions, including anaphylaxis, angioedema, urticaria, and localized and generalized rash; Respiratory: Bronchospasm (predominantly in patients with pre-existing bronchospastic disease); Endocrine: Masked symptoms of hypoglycemia in diabetic patients; Special Senses: Ptosis, decreased corneal sensitivity, cystoid macular edema, visual disturbances including refractive changes and diplopia, pseudopemphigoid, and tinnitus; Urogenital: Retroperitoneal fibrosis, decreased libido, impotence, and Peyronie's disease; Musculoskeletal: Myalgia.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of COSOPT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: bradycardia, cardiac failure, cerebral vascular accident, chest pain, choroidal detachment following filtration surgery, depression, diarrhea, dry mouth, dyspnea, heart block, hypotension, iridocyclitis, myocardial infarction, nasal congestion, Stevens-Johnson syndrome, toxic epidermal necrolysis, paresthesia, photophobia, respiratory failure, skin rashes, urolithiasis, and vomiting.

Timolol (oral administration)

The following additional adverse reactions have been reported in clinical experience with ORAL timolol maleate or other ORAL beta-blocking agents and may be considered potential effects of ophthalmic timolol maleate: Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Body as a Whole: Extremity pain, decreased exercise tolerance, weight loss; Cardiovascular: Worsening of arterial insufficiency, vasodilatation; Digestive: Gastrointestinal pain, hepatomegaly, mesenteric arterial thrombosis, ischemic colitis; Hematologic: Nonthrombocytopenic purpura; thrombocytopenic purpura, agranulocytosis; Endocrine: Hyperglycemia, hypoglycemia; Skin: Pruritus, skin irritation, increased pigmentation, sweating; Musculoskeletal: Arthralgia; Nervous System/Psychiatric: Vertigo, local weakness, diminished concentration, reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometrics; Respiratory: Rales, bronchial obstruction; Urogenital: Urination difficulties.

Read the entire FDA prescribing information for Cosopt (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution)

Cosopt - User Reviews

Cosopt User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Cosopt sorted by most helpful. Patient Discussions FAQs

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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