The recommended dose of Viagra is 25-100 mg taken 30 minutes to 4 hours before sexual activity. Viagra increases the effects of blood pressure lowering medications. It also increases the blood pressure lowering effects of nitrates (for example, isosorbide dinitrate) that are used primarily for treating angina. Patients taking nitrates should not receive Viagra. Viagra should not be combined with Revatio or other PDE5 inhibitors (for example, Levitra [vardenafil], Cialis [tadalafil]). Tagamet (cimetidine), erythromycin, ketoconazole, Sporanox (itraconazole), and Posicor (mibefradil) can cause marked increases in the amount of Viagra in the body. Patients taking these medications should be observed carefully if Viagra is used.
Our Viagra 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.
Viagra 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.
During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil.
Stop using sildenafil and call your doctor at once if you have a serious side effect such as:
sudden vision loss;
ringing in your ears, or sudden hearing loss;
chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
irregular heartbeat;
swelling in your hands, ankles, or feet;
shortness of breath;
vision changes;
feeling light-headed, fainting; or
penis erection that is painful or lasts 4 hours or longer.
Less serious side effects may include:
warmth or redness in your face, neck, or chest;
stuffy nose;
headache;
memory problems;
upset 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 Viagra (Sildenafil Citrate)
Learn More »
Viagra Overview - Patient Information: Side Effects
SIDE EFFECTS: Dizziness, headache, flushing, or stomach upset may occur. Vision changes such as increased sensitivity to light, blurred vision, or trouble telling blue and green colors apart may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
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.
Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away: severe dizziness, fainting, chest/jaw/left arm pain, nausea.
Rarely, sudden decreased vision in one or both eyes (NAION) may occur. This effect may or may not be caused by sildenafil. If this serious problem occurs, stop taking sildenafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke.
Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking sildenafil and get medical help right away if these effects occur.
In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 Viagra (Sildenafil Citrate)
Learn More »
Viagra FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Clinical Trials
VIAGRA (sildenafil citrate) was administered to over 3700 patients (aged 19-87 years) during pre-marketing clinical trials worldwide. Over 550 patients were treated for longer than one year.
In placebo-controlled clinical studies, the discontinuation rate due to adverse events for VIAGRA (sildenafil citrate) (2.5%) was not significantly different from placebo (2.3%). The adverse events were generally transient and mild to moderate in nature.
In trials of all designs, adverse events reported by patients receiving VIAGRA (sildenafil citrate) were generally similar. In fixed-dose studies, the incidence of some adverse events increased with dose. The nature of the adverse events in flexible-dose studies, which more closely reflect the recommended dosage regimen, was similar to that for fixed-dose studies.
When VIAGRA was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials, the following adverse events were reported:
TABLE 2. ADVERSE EVENTS REPORTED BY ≥ 2% OF PATIENTS TREATED WITH VIAGRA (sildenafil citrate) AND MORE FREQUENT ON DRUG THAN PLACEBO IN PRN FLEXIBLE-DOSE PHASE II/III STUDIES
ADVERSE EVENT PERCENTAGE OF PATIENTS VIAGRA
N=734 REPORTING EVENT PLACEBO
N=725
Headache 16% 4%
Flushing 10% 1%
Dyspepsia 7% 2%
Nasal Congestion 4% 2%
Urinary Tract Infection 3% 2%
Abnormal Vision† 3% 0%
Diarrhea 3% 1%
Dizziness 2% 1%
Rash 2% 1%
†Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision. In these studies, only one patient discontinued due to abnormal vision.
Other adverse reactions occurred at a rate of > 2%, but equally common on placebo: respiratory tract infection, back pain, flu syndrome, and arthralgia.
In fixed-dose studies, dyspepsia (17%) and abnormal vision (11%) were more common at 100 mg than at lower doses. At doses above the recommended dose range, adverse events were similar to those detailed above but generally were reported more frequently.
The following events occurred in < 2% of patients in controlled clinical trials; a causal relationship to VIAGRA (sildenafil citrate) is uncertain. Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful:
Body as a whole: face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury.
Cardiovascular: angina pectoris, AV block, migraine, syncope, tachycardia, palpitation, hypotension, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy.
Digestive: vomiting, glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, dry mouth, liver function tests abnormal, rectal hemorrhage, gingivitis.
Hemic and Lymphatic: anemia and leukopenia.
Metabolic and Nutritional: thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia.
Musculoskeletal: arthritis, arthrosis, myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis.
Nervous: ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, somnolence, abnormal dreams, reflexes decreased, hypesthesia.
Respiratory: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased.
Skin and Appendages: urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis.
Special Senses: sudden decrease or loss of hearing, mydriasis, conjunctivitis, photophobia, tinnitus, eye pain, ear pain, eye hemorrhage, cataract, dry eyes.
Urogenital: cystitis, nocturia, urinary frequency, breast enlargement, urinary incontinence, abnormal ejaculation, genital edema and anorgasmia.
Post-Marketing Experience
Cardiovascular and cerebrovascular
Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of VIAGRA (sildenafil citrate) . Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of VIAGRA (sildenafil citrate) without sexual activity. Others were reported to have occurred hours to days after the use of VIAGRA (sildenafil citrate) and sexual activity. It is not possible to determine whether these events are related directly to VIAGRA (sildenafil citrate) , to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors (see WARNINGS for further important cardiovascular information).
Special senses
Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including VIAGRA (sildenafil citrate) . In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of VIAGRA (sildenafil citrate) , to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors (see PATIENT INFORMATION).
Other events
Other events reported post-marketing to have been observed in temporal association with VIAGRA (sildenafil citrate) and not listed in the clinical trial adverse reactions section above include:
Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia.
Urogenital: prolonged erection, priapism (see WARNINGS), and hematuria.
Special Senses: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal vascular disease or bleeding, vitreous detachment/traction, paramacular edema and epistaxis.
Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including VIAGRA (sildenafil citrate) . Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors (see PATIENT INFORMATION).
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