Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: pain or tenderness around the eyes and cheekbones diarrhea or stomach cramps (severe or continuing) numbness or tingling of the hands, legs, or feet redness, soreness, swelling, or bleeding of the gums sensation of motion, usually whirling, either of one's self or of one's surroundings sexual problems in men (continuing), including failure to experience a sexual orgasm sores in the mouth and on the lips Other side effects not listed may also occur in some patients.

Country Approval Status Regulatory Body Allowed Dosages Prescription Needed Notes
USA Approved FDA Up to 50 mg Yes Available under brand names and generics
European Union Approved EMA 20-50 mg Yes Sold by licensed pharmacies
Japan Approved PMDA 25-50 mg Yes Various formulations including liquids
Russia Approved RZN (Russian Federation) 20 mg Yes Licensing varies by manufacturer

If you notice any other effects, check with your healthcare professional.

Vasodilator; Phosphodiesterase Type 5 Inhibitor compounded for dogs and cats.

Children younger than 1 year of age—Use and dose must be determined by your doctor. For oral dosage forms (suspension or tablets): If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of the reach of children.

Does sildenafil interact with foods or drinks?

Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store mixed oral liquid in the refrigerator. Throw away any unused mixed Revatio® oral liquid after 60 days. It is important that you tell all of your doctors that you take sildenafil. Call your doctor for medical advice about side effects.

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You may report side effects to the FDA at 1-800-FDA-1088.

Side Effect Frequency (%) Severity Onset Time Reversibility Recommendations
Headache 15-20 Mild Within 1 hour Reversible Hydration, pain relievers
Flushing 10-15 Mild Within 30 mins Reversible Reduce dose or skip dose
Nasal Congestion 8-12 Mild 30-60 mins Reversible Nasal sprays may help
Dyspepsia 5-10 Mild 1-2 hours Reversible Avoid spicy food, take after meals
Visual Disturbances 2-4 Mild Variable Usually reversible Consult doctor if persistent

Purpose: The stability of sildenafil citrate 2.5 mg/mL in two extemporaneously prepared oral suspensions stored at 4 and 25 ºC was studied.Methods: Thirty 25-mg tablets of sildenafil citrate were ground to powder, and the powder was combined with a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of methylcellulose 1% and Simple Syrup, NF, to produce two 2.5-mg/mL suspensions.

Why is this medication prescribed?

If you experience a prolonged or painful erection for 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis. If you experience a sudden loss of vision in one or both eyes, contact your doctor immediately. Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. If you already use medicine for high blood pressure (hypertension), sildenafil could make your blood pressure go too low.

Sildenafil, a type cGMP phosphodiesterase inhibitor, specifically amplifies endogenous cGMP-dependent relaxation in rabbit corpus cavernosum smooth muscle in vitro

Call your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, sweating, or unusual tiredness or weakness. This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this. Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Five plastic bottles of each suspension were stored in amber plastic prescription bottles at 4 or 25 ºC.

What should I know about storage and disposal of this medication?

Your doctor may adjust your dose as needed.Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose as needed.Children—Use is not recommended. For oral dosage form (tablets):Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose if needed.Children—Use is not recommended. Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse.

Dig Dis Sci

Your doctor may adjust your dose if needed. Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. For oral dosage form (film):Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose as needed. For treatment of pulmonary arterial hypertension:For oral dosage forms (suspension or tablets):Adults—20 milligrams (mg) 3 times a day. Samples were collected on days 0, 7, 14, 28, 42, 56, 70, and 91 for analysis of sildenafil content by high-performance liquid chromatography; pH was also measured.

Society and culture

Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 80 mg 3 times a day.Children 1 year of age and older weighing 45 kilograms (kg) or more—20 mg 3 times a day. However the dose is usually not more than 40 mg 3 times a day.Children 1 year of age and older weighing 20 to 45 kg—20 mg 3 times a day.Children 1 year of age and older weighing 20 kg or less—10 mg 3 times a day.Children younger than 1 year of age—Use and dose must be determined by your doctor. For oral dosage forms (suspension or tablets):Adults—20 milligrams (mg) 3 times a day. Adults—20 milligrams (mg) 3 times a day.

Product Overview

However, the dose is usually not more than 80 mg 3 times a day. Children 1 year of age and older weighing 45 kilograms (kg) or more—20 mg 3 times a day. However the dose is usually not more than 40 mg 3 times a day. Children 1 year of age and older weighing 20 to 45 kg—20 mg 3 times a day. Children 1 year of age and older weighing 20 kg or less—10 mg 3 times a day. Samples were visually observed against black and white backgrounds.Results: The mean concentration of sildenafil citrate exceeded 98% of the initial concentration in all samples at both temperatures throughout the 91-day study period.

No changes in pH, odor, or physical appearance were observed.Conclusion: Sildenafil citrate 2.5 mg/mL in two extemporaneously compounded oral suspensions was stable for 91 days in plastic prescription bottles at 4 and 25 ºC.

Parameter Value Observation Method of Measurement Reference Study
Absorption Time 30-60 minutes Onset of action Blood Plasma Levels Study A
Peak Plasma Concentration 120 ng/mL After 1 hour LC-MS/MS Study B
Half-life 4-5 hours Duration of effective blood levels Pharmacokinetic Models Study C
Bioavailability 40-45% Oral liquid form Pharmacokinetic Analysis Study D

Pulmonary hypertension is a severe illness associated with increased pulmonary vascular resistance and pulmonary artery pressure, which may cause heart failure and death.

Chemical synthesis

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: burning feeling in the chest or stomach burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings decrease in amount of urine or the frequency of urination dizziness or lightheadedness, especially when getting up suddenly from a lying or sitting position dryness, redness, scaling, or peeling of the skin increase in the size of the pupil redness, burning, or swelling of the eyes redness, itching, or tearing of the eyes seeing shades of colors differently than before swelling of the face, hands, feet, or lower legs unusual feeling of burning or stinging of the skin Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. [1,2,3] Inhaled nitric oxide or a continuous i.v. infusion of epo-prostenol is commonly used to treat pulmonary hypertension, but both options are expensive and difficult to use.

References (33)

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine.

J Urol

Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For treatment of erectile dysfunction:For oral dosage form (tablets):Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Alternatively, the medicine may be taken 30 minutes to 4 hours before sexual intercourse. Your doctor may adjust your dose if needed.Adults 65 years of age and older—25 mg as a single dose no more than once a day, 1 hour before sexual intercourse. Your doctor may adjust your dose if needed.Children—Use is not recommended.For oral dosage form (film):Adults up to 65 years of age—50 milligrams (mg) as a single dose no more than once a day, 1 hour before sexual intercourse. Several case reports and small clinical studies have demonstrated the effectiveness of sildenafil in infants and children with pulmonary hypertension.

[4,5,6,7,8,9,10] Sildenafil is a selective inhibitor of cyclic guanosine monophosphate-specific phospho-diesterase-5, which is present in the pulmonary vasculature, thereby enhancing nitric oxide-mediated vasodilation and decreasing pulmonary vascular resistance.

Before Using

If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took sildenafil. Do not use this medicine if you are also using a nitrate medicine, often used to treat angina or high blood pressure. Some illegal ("street") drugs called sildenafil tablet manforce 50 mg "poppers" (such as amyl nitrate, butyl nitrate, or nitrite). Do not use this medicine if you also use riociguat (Adempas®). If you will be taking this medicine for pulmonary arterial hypertension, your doctor will want to check your progress at regular visits.

More common

This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. If you take sildenafil for pulmonary arterial hypertension, do not take Viagra®, Vibrique™ or other PDE5 inhibitors, including tadalafil (Cialis®) or vardenafil (Levitra®). If you take too much sildenafil or take it together with these medicines, the chance for side effects will be higher. It is important to tell your doctor about any heart problems you have now or may have had in the past. This medicine can cause serious side effects in patients with heart problems.