13 NONCLINICAL TOXICOLOGY
Sildenafil oral tablet doesn’t cause drowsiness, but it can cause other side effects, including: flushing (reddening and warming of the face) an erection that lasts longer than normal If these effects are mild, they may go away within a few days or a couple of weeks.
Drug Label Information
Kaplan-Meier Plot of Time (in Days) to Clinical Worsening of PAH in PACES-1 Improvements in WHO Functional Class for PAH were also demonstrated in patients on sildenafil compared to placebo. More than twice as many sildenafil-treated patients (36%) as placebo-treated patients (14%) showed an improvement in at least one functional New York Heart Association (NYHA) class for PAH. Study A1481243 (NCT00323297) - Sildenafil Added to Bosentan Therapy – Lack of Effect on Exercise Capacity A randomized, double-blind, placebo-controlled study was conducted in 103 patients with PAH who were on bosentan therapy for a minimum of 3 months. Hazard ratio estimates from the proportional Hazards model, stratified by actual previous PAH treatment and Kaplan-Meier estimates of survival at 3 years were 66%, 79%, and 85% in the 5-, 20-, and 80- mg TID dose groups, respectively. Abbreviations: 6MWD = 6-minute walk distance; CI = confidence interval; PAH = pulmonary arterial hypertension.
What is sildenafil used for?
Clinical worsening events were defined as reduction from baseline in the 6MWD test by at least 15% and worsening functional class from baseline, both confirmed by a second test/evaluation within 2 weeks. Count of cases of disease progression as the first event of clinical worsening. c. Count of non-elective hospital stays for worsening PAH as the first event of clinical worsening. d. If they’re more severe or don’t go away, talk with your doctor or pharmacist. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following: Symptoms can include:blurry visionconfusiondizzinessfaintinglightheadednessnausea or vomitingsleepinessweakness Increased shortness of breath or trouble breathing Priapism (an erection that lasts more than 4 hours) Symptoms can include:sudden vision loss in one or both eyes sudden vision loss in one or both eyes Symptoms can include:sudden hearing losstinnitus (ringing in your ears)dizziness Heart problems, such as heart attack, stroke, or irregular heart rate. Symptoms can include:chest painshortness of breathdizzinesstrouble speakingconfusionnausea or vomitingfeeling lightheaded Priapism warning: This drug can cause priapism, which is an erection that won’t go away.
- Sildenafil tablets are available in various generic versions.
- White sildenafil tablets are often easier to swallow due to their shape.
- The cost of sildenafil varies depending on the brand and dosage.
- Using sildenafil responsibly can improve quality of life for users.
- Not all erectile issues require medication; consult a doctor for underlying causes.
- Sildenafil is not suitable for women or children.
- The drug works by blocking PDE5, enhancing natural erections.
- Physical activity after taking sildenafil can enhance its effectiveness.
- Sildenafil is sometimes used off-label for pulmonary hypertension.
- Proper hydration may help reduce side effects like headaches.
- Patients should report any persistent or severe side effects to a healthcare professional.
If you have an erection that lasts more than 4 hours, call 911 or go to the nearest emergency room.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Viagra Generic | 150mg | 180 + 10 Pills | 236.46€ 225.20€ | |
| Viagra Generic | 100mg | 10 Pills | 28.91€ 27.53€ | |
| Viagra Generic | 200mg | 20 Pills | 61.69€ 58.75€ | |
| Viagra Generic | 200mg | 360 + 10 Pills | 481.98€ 459.03€ | |
| Kamagra Soft Tabs | 100mg | 12 Pills | 57.55€ 54.81€ | |
| Viagra Generic | 100mg | 60 + 4 Pills | 96.36€ 91.77€ | |
| Viagra Generic | 150mg | 30 + 2 Pills | 72.32€ 68.88€ | |
| Viagra Generic | 50mg | 60 + 4 Pills | 83.93€ 79.93€ | |
| Kamagra | 100mg | 20 Pills | 86.09€ 81.99€ | |
| Viagra Generic | 150mg | 360 + 10 Pills | 423.48€ 403.31€ | |
| Kamagra | 100mg | 180 + 6 Pills | 436.79€ 415.99€ | |
| Viagra Generic | 100mg | 90 + 6 Pills | 129.02€ 122.88€ | |
| Viagra Generic | 25mg | 30 + 4 Pills | 47.97€ 45.69€ |
If it’s not treated right away, this condition can cause permanent damage to your penis. Sudden vision loss warning: This drug can cause sudden vision loss in one or both eyes. This can be a sign of a serious eye problem. If this occurs, stop taking sildenafil and call your doctor right away. Sudden hearing loss warning: This drug can cause hearing loss, tinnitus (ringing in your ears), or dizziness. If you have sudden hearing loss with or without tinnitus or dizziness, stop taking sildenafil and call your doctor right away. Use in children warning: Children generally should not take sildenafil; however, there are instances where the drug is considered the best treatment option. Talk with your child’s doctor to better understand the benefits and risks associated with this treatment option. Sildenafil oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking.
| Storage Condition | Details | Notes |
|---|---|---|
| Temperature | Keep below 30°C (86°F) | Avoid excessive heat |
| Light | Keep away from direct sunlight | Protect from UV rays |
| Humidity | Store in dry place | Prevent moisture from degrading the tablet |
| Out of reach | Keep out of children's reach | Safety precaution |
To find out how this drug might interact with something else you’re taking, talk with your doctor or pharmacist. Examples of drugs that can cause interactions with sildenafil are listed below.
My “little blue pill” isn’t blue, it’s white. Is this normal?
A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions. Sildenafil works in different ways, depending on the condition it’s being used to treat. For ED: Sildenafil works pfizer sildenafil 50 by increasing blood flow to the penis. This helps you get or maintain an erection.
Why it’s used
Sildenafil only works for ED if you’re sexually aroused. For PAH: Sildenafil works by relaxing the muscles and opening up the blood vessels in your lungs. This decreases the blood pressure in your lungs. Sildenafil slows down the progression of your illness. It also makes you more able to exercise. Do not take these drugs with sildenafil.
- Sildenafil tablets are sometimes prescribed for conditions other than ED.
- The active ingredient aids in relaxing blood vessels in the body.
- White sildenafil tablets are often associated with certain pharmaceutical brands.
- Some countries have strict regulations on sildenafil distribution and sale.
- Sildenafil is typically not recommended for men with severe eyesight diseases.
- Adherence to prescribed guidelines optimizes treatment outcomes.
- The tablets are manufactured with quality control practices to ensure safety.
- Patients should avoid sudden changes in medication or dosage.
- Reactions to sildenafil can be immediate or delayed; monitor closely.
- Lifestyle factors like smoking can influence sildenafil’s effectiveness.
- Educate yourself on proper storage to maintain medication integrity.
Doing so can cause dangerous effects in the body. Nitrates, such as isosorbide mononitrate, isosorbide dinitrate, or nitroglycerin.Taking these drugs with sildenafil can cause your blood pressure to drop suddenly to an unsafe level.
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
It’s also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in every strength or form as the brand-name drug. Generic oral tablets are available for both conditions, but the brand-name drugs each treat only one of the conditions. Viagra: This drug is used to treat ED.
What are the most common side effects of sildenafil?
With ED, you’re unable to get or maintain an erection. Revatio: This drug is used to treat PAH. With PAH, the blood pressure in your lungs is too high. Your heart has to work very hard to pump blood into your lungs. Sildenafil belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors. Taking these drugs with sildenafil can cause your blood pressure to drop suddenly to an unsafe level. Guanylate cyclase stimulators, such as riociguat.Taking these drugs with sildenafil can cause your blood pressure to drop suddenly to an unsafe level.
AN 355
Advise patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors. Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil. Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil. PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg (90 Tablet Bottle) Sildenafil oral tablet is available as a brand-name drug and as a generic drug. Sildenafil comes in three forms: an oral tablet, an oral suspension (liquid), and an injection that’s only given by a doctor.
Is Teva sildenafil the same as Viagra?
Sildenafil oral tablet is used to treat erectile dysfunction (ED). It’s also used to treat pulmonary arterial hypertension (PAH). It comes in the form of a tablet and suspension (liquid). It also comes in an intravenous (IV) form, which is only given by a doctor. Sildenafil oral tablet is available as the brand-name drugs Viagra and Revatio. Side effects from sildenafil: Taking sildenafil with certain medications raises your risk for side effects from sildenafil. This is because the amount of sildenafil in your body is increased.
Why is this medication prescribed?
Sildenafil can be used as early as 4 hours before sex and as late as 30 minutes before sex. However, it is recommended to use this drug within an hour before sex. Sildenafil should not be taken for ED more than once in a 24-hour period. But if you have certain medical conditions or are taking other drugs, your doctor may recommend that you take this drug less often than once a day. It is important to note that certain foods, particularly foods high in fat, can cause the drug to work more slowly than normal. HIV drugs, such as ritonavir, indinavir, saquinavir, or atazanavir.Increased side effects can include low blood pressure, dizziness, or vision problems. They can also include erections that last longer than normal.
5.8 Effects on Bleeding
Count of deaths as the first event of clinical worsening. e. Hazard ratio estimates from the proportional Hazards model, stratified by actual previous PAH treatment and etiology of PAH. 16 HOW SUPPLIED/STORAGE AND HANDLING Sildenafil Tablets USP, 20 mg are white colored, round shape, biconvex, film-coated tablets, debossed with ‘T’ on one side and ‘27’ on other side.Bottles of 90 NDC 65862-688-90Bottles of 1,000 NDC 65862-688-99Recommended Storage for Sildenafil Tablets USP: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Sildenafil Tablets USP, 20 mg are white colored, round shape, biconvex, film-coated tablets, debossed with ‘T’ on one side and ‘27’ on other side.
Recreational use
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).Inform patients of contraindication of sildenafil with regular and/or intermittent use of organic nitrates.Inform patients that sildenafil is also marketed as VIAGRA for erectile dysfunction. Advise patients taking sildenafil not to take VIAGRA or other PDE-5 inhibitors.Advise patients to seek immediate medical attention for a sudden loss of vision in one or both eyes while taking sildenafil. Such an event may be a sign of NAION.Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking sildenafil. These events may be accompanied by tinnitus and dizziness.Distributed by:Aurobindo Pharma USA, Inc.279 Princeton-Hightstown RoadEast Windsor, NJ 08520Manufactured by:Aurobindo Pharma LimitedHyderabad-500 032, IndiaRevised: 02/2026 Advise the patient to read the FDA-approved patient labeling (Patient Information). Inform patients of contraindication of sildenafil with regular and/or intermittent use of organic nitrates. Increased side effects can include low blood pressure, dizziness, or vision problems. Certain antibiotics, such as clarithromycin or erythromycin.Increased side effects can include low blood pressure, dizziness, or vision problems. Certain antifungals, such as ketoconazole or itraconazole.Increased side effects can include low blood pressure, dizziness, or vision problems. Side effects from other drugs: Taking sildenafil with certain medications raises your risk for side effects from these drugs.
| Brand Name | Manufacturer | Dosage | Market Region | Price Range (USD) | Packaging Options |
|---|---|---|---|---|---|
| Viagra | Pfizer | 50 mg | Global | 10-20 per pill | Blister pack of 4-12 pills |
| Revatio | Pfizer | 20 mg | Global | 15-25 per pill | Blister pack of 30 pills |
| Kamagra | Ajanta Pharma | 50 mg | India, SE Asia | 2-5 per pill | Varies (blister) |
| Sildenafil Original | Local Pharmacies | 50 mg | Local Markets | 12-18 per pill | Bottle/Blister |