Viagra Oral Jelly Side Effects



Is Kamagra Oral Jelly an effective treatment for erectile dysfunction?

Kamagra Oral Jelly is an unlicensed, unverified product sold over the internet without a prescription, claiming to treat erectile dysfunction (ED). Many of these medications have been proven to be fake, and some even contain dangerous substances. We don’t know if Kamagra Oral Jelly works, but it’s not worth the risk. There are safe and effective treatment options available for ED.

table of contents

Disclaimer

If you have any medical questions or concerns, please talk to your healthcare provider. The articles on Health Guide are underpinned by peer-reviewed research and information drawn from medical societies and governmental agencies. However, they are not a substitute for professional medical advice, diagnosis, or treatment.

We’ve all gotten those spam emails or pop-up men’s health ads promising virility and stronger erections—and when you have erectile dysfunction (ED), you might feel desperate to try anything. That’s understandable, but don’t be fooled. Knockoff, unlicensed products that promise the same results as Viagra are risky. At best, they just don’t work, and at worst, they can be dangerous.

Kamagra Oral Jelly is one such product that’s not approved in the U.S. and may carry the same risks as any unlicensed Viagra-like product. Let’s look at what this product is, why taking it isn’t a good idea, and reliable treatment options we recommend instead.

Get $15 off your first month of ED treatment

If prescribed, get ED treatment delivered discreetly directly to your door.

What is Kamagra Oral Jelly?

According to its website, Kamagra is a company based in Hungary that sells multiple products that they claim function the same way as popular phosphodiesterase-5 (PDE5) inhibitors, the drugs most commonly used to treat erectile dysfunction. Sildenafil (brand name Viagra; see Important Safety Information), tadalafil (brand name Cialis; see Important Safety Information), and vardenafil (brand name Levitra) are all examples of PDE5 inhibitors.

Kamagra claims that their Kamagra Oral Jelly product is an edible formulation containing sildenafil citrate, the same active ingredient in Viagra. They claim that it’s manufactured by Ajanta Pharma Ltd, a pharmaceutical company based in India.

We cannot verify these claims since there’s no research behind this product (nor any of the products sold by Kamagra). No studies exist on these formulations and they are not approved or available in the United States or the United Kingdom (Jackson, 2010).

While you might be able to buy them in Europe, that doesn’t mean that any of the local countries’ medical boards approve of these products.

We know–the medical system can sometimes feel overly bureaucratic. You just want easy access to products that can help you overcome a troubling issue like ED. If the company claims it contains the same active ingredient as Viagra, what’s the harm in trying it? Here’s why it’s not a good idea.

Why you shouldn’t take Kamagra Oral Jelly to treat your ED

So, let’s say Kamagra Oral Jelly does contain sildenafil citrate, as it claims. Even if that’s true, there’s no way to know what else might be in it because it’s an unlicensed, unregulated product.

The same can be said of any medication sold over the internet by an unlicensed distributor.

In fact, it’s estimated that as much as 90% of drugs sold over the internet are counterfeit, with PDE5 inhibitors in the lead. Most of the faux Viagra drugs sold online contain far less sildenafil than they claim (for example, one investigation found a product containing 30 mg of sildenafil when they’d claimed it had 100 mg). Some don’t contain any sildenafil at all and may just be repackaged acetaminophen (brand name Tylenol) or other medications. Worst of all, many investigations have found dangerous substances added to these drugs, such as (Jackson, 2010):

  • Talcum powder
  • Amphetamines
  • Paint
  • Printer ink

The real danger in buying Kamagra Oral Jelly or any other drug over the internet without a prescription is you simply don’t know what might be in it. Side effects and possible allergic reactions are unpredictable and can be dangerous. And you don’t know which other medications you should avoid while taking it, as a hidden ingredient in the internet drug might interact with a medication you’re currently taking.

8 natural remedies and treatments for erectile dysfunction

Plus, erection problems are often the first sign of a more serious medical condition, such as hypertension (high blood pressure), so it’s important to speak with a licensed healthcare provider if you’re having trouble getting and maintaining an erection rather than trying out a medication you find online (Hernández-Cerda, 2020).

Bottom line: The risks of taking these meds are very real and potentially deadly.

Recommended treatment options for erectile dysfunction

While we can’t recommend taking Kamagra Oral Jelly or any other drugs purchased online from an unlicensed pharmacy, there are many safe and effective options for treating your erectile dysfunction.

PDE5 inhibitors

The real-deal PDE5 inhibitors are effective, safe, and well-tolerated by most patients.

Here’s how these work to improve erections: PDE5 is an enzyme that breaks down a chemical called cyclic guanosine monophosphate (cGMP). cGMP causes the blood vessels in the penis to relax. When PDE5 is blocked by PDE5 inhibitors, cGMP increases, causing more blood to flow into the penis. More blood flow to the penis makes for stronger erections (Dhaliwal, 2020).

There are four main types of PDE5 inhibitors.

Sildenafil

Sildenafil is the generic name for Viagra. It is also marketed as Revatio (see Important Safety Information), but that brand name is only FDA-approved for a condition called pulmonary arterial hypertension (FDA, 2007). At the highest dose (100 mg), sildenafil is effective in 84% of patients. It works within 30–60 minutes of taking it, and it’s best if you don’t take it with a heavily fatty meal (Hatzimouratidis, 2010).

Tadalafil

Cialis is the brand name for tadalafil. This drug works similarly to sildenafil, but it has a longer half-life, which means that it lasts for longer in the body (15-17.5 hours hours vs. 4–6 hours with sildenafil). It should be taken 30 minutes to two hours before sexual activity (Gong, 2017).

Vardenafil

Finally, vardenafil (which is sold under the brand names Levitra or Staxyn) has a very similar profile to sildenafil, but it’s more potent. This doesn’t necessarily mean it works better, but the medication comes in lower doses than sildenafil. You should take it about 30–60 minutes before sexual intercourse (Hatzimouratidis, 2010).

Avanafil

Avanafil is a newer PDE5 inhibitor that’s currently only available under the brand name, Stendra (FDA-b). It’s not used very widely at this point (likely because it’s more expensive since it’s still under patent), but the research is promising. A big advantage is it works within 15 minutes of taking it, and it lasts for up to 6 hours (Katz, 2014).

Erectile dysfunction support sleeve: does it work?

Injectable and intraurethral therapies

PDE5 inhibitors are the first-line treatment for ED because they work well for most patients. There are other treatments available, though, if you’re in the minority of patients who don’t respond well to sildenafil, tadalafil, vardenafil, or avanafil, or if you cannot take these medications due to other medical reasons.

One option is an injection that goes into the shaft of the penis. Alprostadil is the primary medication available. As an injectable, it’s available under the brand names Caverject, Edex, or Viridal. Much like PDE5 inhibitors, alprostadil lets blood flow more freely into the penis, a necessary part of an erection (Jain, 2020).

Another option is an intraurethral medication, which is a medication in the form of a pellet or gel that gets inserted into the penis. Again, alprostadil is the primary medication used, but there are also combination medications available. One is called BiMix (a combination of two medications: papaverine and phentolamine), and the other is called TriMix (three drugs combined: papaverine, phentolamine, and alprostadil) (Tharyan, 2006).

Shockwave therapy

Low-intensity extracorporeal shockwave therapy (Li-ESWT) is a newer treatment that’s not being widely used yet, but studies are promising. We don’t quite understand how this treatment works, but there seems to be evidence that this treatment might actually reverse damage to the erectile tissue, possibly having a more permanent effect (Gruenwald, 2013).

Surgical implant

This is usually a last resort, but if all other therapies fail, a surgical implant is an option. This is a device or prosthetic that gets surgically inserted into the penis. While surgery is an extreme measure, most patients who wind up going this route are very satisfied with their results, and there are limited complications (Hatzimouratidis, 2010).

Be careful with your medications

If you have erectile dysfunction, it’s important to follow the medical advice of your healthcare provider. Trying to diagnose and medicate yourself by buying unknown substances from unlicensed providers can be dangerous. And with so many safe and effective treatments available, the risks of those knockoff medications outweigh any possible benefits. Make sure to use a safe and verified treatment for erectile dysfunction.

References

  1. Dhaliwal A, Gupta M (2020). PDE5 Inhibitor. StatPearls. Retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK549843/
  2. Gong, B., Ma, M., Xie, W., Yang, X., Huang, Y., Sun, T., Luo, Y., & Huang, J. (2017). Direct comparison of tadalafil with sildenafil for the treatment of erectile dysfunction: a systematic review and meta-analysis. International Urology and Nephrology, 49(10), 1731–1740. Doi: 10.1007/s11255-017-1644-5. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5603624/
  3. Gruenwald, I., Appel, B., Kitrey, N. D., & Vardi, Y. (2013). Shockwave treatment of erectile dysfunction. Therapeutic Advances in Urology, 5(2), 95–99. Doi: 10.1177/1756287212470696. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3607492/
  4. Hatzimouratidis, K., Amar, E., Eardley, I., et al (2010). Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. European Urology, 57(5), 804–814. Doi: 10.1016/j.eururo.2010.02.020. Retrieved from https://pubmed.ncbi.nlm.nih.gov/20189712/
  5. Hernández-Cerda, J., Bertomeu-González, V., Zuazola, P., & Cordero, A. (2020). Understanding Erectile Dysfunction in Hypertensive Patients: The Need for Good Patient Management. Vascular Health and Risk Management, 16, 231–239. Doi: 10.2147/VHRM.S223331. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7297457/
  6. Jackson, G., Arver, S., Banks, I., & Stecher, V. J. (2010). Counterfeit phosphodiesterase type 5 inhibitors pose significant safety risks. International Journal of Clinical Practice, 64(4), 497–504. Doi: 10.1111/j.1742-1241.2009.02328.x. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3069491/
  7. Jain A, Iqbal OA (2020). Alprostadil. StatPearls. Retrieved from: https://www.ncbi.nlm.nih.gov/books/NBK542217/
  8. Katz, E. G., Tan, R. B., Rittenberg, D., & Hellstrom, W. J. (2014). Avanafil for erectile dysfunction in elderly and younger adults: differential pharmacology and clinical utility. Therapeutics and Clinical Risk Management, 10, 701–711. Doi: 10.2147/TCRM.S57610. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4155803/
  9. Tharyan, P., & Gopalakrishanan, G. (2006). Erectile dysfunction. BMJ Clinical Evidence, 2006, 1803. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2907627/
  10. U.S. Food and Drug Administration (FDA-a). (2007). Revatio (sildenafil citrate) tablets. Retrieved at https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021845s005lbl.pdf on January 17, 2021.
  11. U.S. Food and Drug Administration (FDA-b). (2012). Stendra (avanafil) tablets, for oral use. Retrieved at https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202276s000lbl.pdf on January 20, 2021.

What causes erectile dysfunction (ED) in men over 50?

Does COVID-19 cause erectile dysfunction? Could ED cause COVID-19?

Erectile dysfunction (ED) and mental health

8 natural remedies and treatments for erectile dysfunction

Rhino pills: an effective treatment for ED, or a scam?

Erectile dysfunction support sleeve: does it work?

7 foods that help you stay erect

Autoimmune diseases and erectile dysfunction (ED)

Digital Health Clinic for Men

Digital Health Clinic for Women

Simple, Affordable Online Pharmacy

The Patient Company

Important Safety Information for Sildenafil (Viagra)

What are the most important things I need to know about VIAGRA® (sildenafil citrate) 25 mg, 50 mg, and 100 mg tablets and generic VIAGRA®?

Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sex, seek immediate emergency medical attention.

  • VIAGRA® and generic VIAGRA® can cause serious side effects. Serious, but rare, side effects include:
    • an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, seek emergency medical attention right away. If it is not treated right away, priapism can permanently damage your penis.
    • sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking VIAGRA and call your healthcare provider right away if you have any sudden vision loss
    • sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking VIAGRA and contact a doctor right away

    Who should not take VIAGRA® or generic VIAGRA®?

    Do not take VIAGRA® or generic VIAGRA® if you:

    • Take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level
    • Are allergic to sildenafil, as contained in VIAGRA® and REVATIO®, or any of the ingredients in VIAGRA® or generic VIAGRA® tablets.
    • Are a women or a child

    When should I call my primary provider?

    Call your primary provider right away if you:

    • Have an erection that lasts longer than 4 hours
    • Experience a sudden loss of vision in one or both eyes
    • Experience a sudden decrease in or loss of hearing
    • Experience chest pain, dizziness, or nausea during sex
    • Take too much Viagra or sildenafil citrate

    If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

    What are the most common side effects of VIAGRA® and generic VIAGRA®?

    The most common side effects are:

    • headache
    • flushing
    • upset stomach
    • abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision
    • stuffy or runny nose
    • back pain
    • muscle pain
    • nausea
    • dizziness
    • rash

    What should I tell my Roman-affiliated provider before taking VIAGRA® and generic VIAGRA®?

    Before you take VIAGRA® or generic VIAGRA® , tell your healthcare provider if you:

    • Have or have had heart problems such as a heart attack,irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure
    • Have had heart surgery within the last 6 months
    • Have pulmonary hypertension
    • Have had a stroke
    • Have low blood pressure, or high blood pressure that is not controlled
    • Have a deformed penis shape
    • Have had an erection that lasted for more than 4 hours
    • Have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia
    • Have retinitis pigmentosa, a rare genetic (runs in families) eye disease
    • Have ever had severe vision loss, including an eye problem called NAION
    • Have bleeding problems
    • Have or have had stomach or intestinal ulcers
    • Have liver problems
    • Have kidney problems or are having kidney dialysis
    • Have any other medical conditions

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    VIAGRA may affect the way other medicines work, and other medicines may affect the way VIAGRA works, causing side effects.

    Especially tell your healthcare provider if you take any of the following:

    • Medicines called nitrates
    • Medicines called guanylate cyclase stimulators such as Adempas® (riociguat)
    • Medicines called alpha-blockers such as Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl), or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of VIAGRA® with alpha-blockers can lead to a drop in blood pressure or to fainting
    • Medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir sulfate (Crixivan®), saquinavir (Fortovase® or Invirase®), or atazanavir sulfate (Reyataz®)
    • Oral antifungal medicines, such as ketoconazole (Nizoral®) and itraconazole (Sporanox®)
    • Antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin
    • Other medicines that treat high blood pressure
    • Other medicines or treatments for ED
    • VIAGRA® contains sildenafil, which is the same medicine found in another drug called REVATIO®. REVATIO® is used to treat a rare disease called pulmonary arterial hypertension (PAH). VIAGRA® should not be used with REVATIO® or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil])

    Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

    What is the FDA-approved use of VIAGRA® and generic VIAGRA®?

    VIAGRA® (sildenafil citrate) is prescription medicine used to treat erectile dysfunction (ED).

    Roman-affiliated doctors may prescribe VIAGRA® or generic VIAGRA® for the treatment of premature ejaculation (PE), if they believe in their medical judgment that it is an appropriate course of treatment. While this is not an FDA-approved use of the drug, the American Urological Association has included the use of sildenafil citrate in the treatment of PE in its Guideline on the Pharmacologic Management of Premature Ejaculation.

    You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    Please see the full Prescribing Information for complete safety information.

    Product names referenced herein are trademarks of their respective owners.

    Important Safety Information for Tadalafil (Cialis)

    What Is The Most Important Information I Should Know About CIALIS® (tadalafil) and generic CIALIS®?

    • CIALIS® and generic CIALIS® can cause serious side effects. Serious, but rare, side effects include:
      • An erection that won’t go away (priapism). If you get an erection that lasts more than 4 hours, get medical help right away. Priapism must be treated as soon as possible or lasting damage can happen to your penis, including the inability to have erections.
      • Changes in vision. Color vision changes, such as seeing a blue tinge (shade) to objects or having difficulty telling the difference between the colors blue and green.
      • Sudden decrease or loss of vision. In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including CIALIS® and generic CIALIS®) reported a sudden decrease or loss of vision in one or both eyes. It is uncertain whether PDE5 inhibitors directly cause the vision loss. If you experience sudden decrease or loss of vision, stop taking PDE5 inhibitors, including CIALIS® and generic CIALIS®, and call a healthcare provider right away.
      • Sudden loss or decrease in hearing. Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including CIALIS® and generic CIALIS®. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience these symptoms, stop taking CIALIS® and generic CIALIS® and contact a healthcare provider right away.
      • ED is a condition where the penis does not fill with enough blood to harden and expand when a man is sexually excited, or when he cannot keep an erection. A man who has trouble getting or keeping an erection should see his healthcare provider for help if the condition bothers him.
      • CIALIS® and generic CIALIS® help increase blood flow to the penis and may help men with ED get and keep an erection satisfactory for sexual activity. Once a man has completed sexual activity, blood flow to his penis decreases, and his erection goes away. Some form of sexual stimulation is needed for an erection to happen with CIALIS® or generic CIALIS®.
      • CIALIS® and generic CIALIS® do not:
        • Cure ED
        • Increase a man’s sexual desire
        • Protect a man or his partner from sexually transmitted diseases, including HIV. Speak to your healthcare provider about ways to guard against sexually transmitted diseases.
        • Serve as a male form of birth control
        • Take CIALIS® or generic CIALIS® exactly as your healthcare provider prescribes it. Your healthcare provider will prescribe the dose that is right for you. Do not change your dose or the way you take CIALIS® or generic CIALIS® without talking to your healthcare provider.

        Who Should Not Take CIALIS® or generic CIALIS®?

        Do not take CIALIS® or generic CIALIS® if you:

        • Have severe liver disease. Tell your doctor if you have mild to moderate liver disease as you may need dosage reductions.
        • Have severe kidney disease. Tell your doctor if you have mild to moderate kidney disease as you may need dosage reductions
        • Take any medicines called “nitrates”
        • Use recreational drugs called “poppers” like amyl nitrite and butyl nitrite
        • Take any medicines called guanylate cyclase stimulators, such as riociguat
        • Are allergic to CIALIS®, tadalafil or ADCIRCA®, or any of its ingredients

        When should I call my primary provider?

        Call your primary provider right away if you:

        • Have an erection that lasts longer than 4 hours
        • Experience a sudden loss of vision in one or both of your eyes
        • Experience a sudden decrease or loss hearing
        • Take too much CIALIS® or generic CIALIS®
        • Have an allergic reaction to CIALIS® or generic CIALIS®
        • Symptoms of an allergic reaction may include:
        • Rash
        • Hives
        • Swelling of the lips, tongue, or throat
        • Difficulty breathing or swallowing

        Call your healthcare provider or get help right away if you have any of the symptoms of an allergic reaction listed above.

        If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

        What Should I Tell My Roman-affiliated Provider Before Taking CIALIS® and generic CIALIS®?

        Tell your Roman-affiliated provider about all your medical problems, including if you:

        • Have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack. Ask your healthcare provider if it is safe for you to have sexual activity. You should not take CIALIS® and generic CIALIS® if your healthcare provider has told you not to have sexual activity because of your health problems.
        • Have pulmonary hypertension
        • Have low blood pressure or have high blood pressure that is not controlled
        • Have had a stroke
        • Have liver problems
        • Have kidney problems or require dialysis
        • Have retinitis pigmentosa, a rare genetic (runs in families) eye disease
        • Have ever had severe vision loss, including a condition called NAION
        • Have stomach or intestinal ulcers
        • Have a bleeding problem
        • Have a deformed penis shape or Peyronie’s disease
        • Have had an erection that lasted more than 4 hours
        • Have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia

        Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

        Especially tell your healthcare provider if you take any of the following:

        • Medicines called nitrates
        • Medicines called guanylate cyclase stimulators, such as riociguat (Adempas®), used to treat pulmonary hypertension
        • Medicines called alpha blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), 4 Jalyn® (dutasteride and tamsulosin HCl) or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. If CIALIS® or generic CIALIS® is taken with certain alpha blockers, your blood pressure could suddenly drop. You could get dizzy or faint.
        • Other medicines to treat high blood pressure (hypertension)
        • Medicines called HIV protease inhibitors, such as ritonavir (Norvir® , Kaletra® )
        • Oral antifungals such as ketoconazole (Nizoral® ), itraconazole (Sporanox® )
        • Antibiotics such as clarithromycin (Biaxin® ), telithromycin (Ketek® ), erythromycin (several brand names exist. Please consult your healthcare provider to determine if you are taking this medicine).
        • Other medicines or treatments for ED.
        • Tadalafil is also marketed as ADCIRCA® for the treatment of pulmonary arterial hypertension. Do not take both CIALIS® or generic CIALIS® and ADCIRCA®. Do not take sildenafil citrate (Revatio®, Viagra®) with CIALIS® or generic CIALIS®.

        Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

        What are the most common side effects of CIALIS® or generic CIALIS®?

        The most common side effects with CIALIS® and generic CIALIS® are:

        • Headache
        • Indigestion
        • Back pain
        • Muscle aches
        • Flushing
        • Stuffy or runny nose

        What is the FDA-approved Use of CIALIS® and generic CIALIS®?

        CIALIS® and generic CIALIS® are prescription medicines used to treat erectile dysfunction (ED), symptoms of benign prostatic hyperplasia (BPH), or both.

        Roman-affiliated doctors may prescribe CIALIS® for the treatment of premature ejaculation (PE), if they believe in their medical judgment that it is an appropriate course of treatment.

        You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

        Please see the full Prescribing Information for complete safety information.

        Important Safety Information for Sildenafil (Revatio)

        This Important Safety Information has been adapted from the Prescribing Information for REVATIO®.

        What are the most important things I need to know about sildenafil 20 mg tablets?

        • Discuss your health with your doctor to ensure that you are healthy enough for sex. If you experience chest pain, dizziness, or nausea during sex, seek immediate emergency medical attention.
        • Sildenafil can cause serious side effects. Serious, but rare, side effects include:
          • an erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, seek emergency medical attention right away. If it is not treated right away, priapism can permanently damage your penis
          • sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). Stop taking sildenafil and call your healthcare provider right away if you have any sudden vision loss
          • sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness. If you have these symptoms, stop taking sildenafil and contact a doctor right away

          Who should not take sildenafil?

          Do not take sildenafil if you:

          • Take any medicines called nitrates, often prescribed for chest pain, or guanylate cyclase stimulators like Adempas (riociguat) for pulmonary hypertension. Your blood pressure could drop to an unsafe level
          • Are allergic to sildenafil, as contained in VIAGRA® and REVATIO®, or any of the ingredients in generic sildenafil citrate tablets.
          • You’ve ever had blockage of veins in your lungs, which is called pulmonary veno-occlusive disease
          • Are a women or a child

          Sildenafil contains the same medicine as VIAGRA® (sildenafil citrate), which is used to treat erectile dysfunction (impotence) and REVATIO®, which is used to treat pulmonary hypertension. Do not take sildenafil with VIAGRA, REVATIO, or other PDE5 inhibitors.

          When should I call my primary provider?

          Call your primary provider if you:

          • Have an erection that lasts longer than 4 hours
          • Experience a sudden loss of vision in one or both eyes
          • Experience a sudden decrease in or loss of hearing
          • Take too much sildenafil citrate

          If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

          What are the most common side effects of generic sildenafil citrate?

          The most common side effects are:

          • Headache
          • Flushing
          • Upset stomach
          • Abnormal vision, such as changes in color vision (such as having a blue color tinge) and blurred vision
          • Stuffy or runny nose
          • Back pain
          • Muscle pain
          • Nausea
          • Dizziness
          • Rash
          • Trouble sleeping
          • Fever
          • Respiratory infection
          • Nausea
          • Vomiting
          • Bronchitis
          • Pharyngitis

          What should I tell my Roman-affiliated provider before taking sildenafil citrate?

          Before you take sildenafil citrate, tell your healthcare provider if you:

          • Have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve, or heart failure
          • Have had heart surgery within the last 6 months
          • Have pulmonary hypertension
          • Have had a stroke
          • Have low blood pressure, or high blood pressure that is not controlled
          • Have a deformed penis shape
          • Have had an erection that lasted for more than 4 hours
          • Have problems with your blood cells such as sickle cell anemia, multiple myeloma, or leukemia
          • Have retinitis pigmentosa, a rare genetic (runs in families) eye disease
          • Have ever had severe vision loss, including an eye problem called NAION
          • Have bleeding problems
          • Have or have had stomach or intestinal ulcers
          • Have liver problems
          • Have kidney problems or are having kidney dialysis
          • Have any problem with the shape of your penis or Peyronie’s disease
          • Have any other medical conditions

          Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

          Sildenafil may affect the way other medicines work, and other medicines may affect the way sildenafil works, causing side effects.

          Especially tell your healthcare provider if you take any of the following:

          • Medicines called nitrates
          • Medicines called guanylate cyclase stimulators such as Adempas® (riociguat)
          • Medicines called alpha-blockers such as Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), Jalyn® (dutasteride and tamsulosin HCl), or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of VIAGRA® with alpha-blockers can lead to a drop in blood pressure or to fainting
          • Medicines called HIV protease inhibitors, such as ritonavir (Norvir®), indinavir sulfate (Crixivan®), saquinavir (Fortovase® or Invirase®), or atazanavir sulfate (Reyataz®)
          • Oral antifungal medicines, such as ketoconazole (Nizoral®) and itraconazole (Sporanox®)
          • Antibiotics, such as clarithromycin (Biaxin®), telithromycin (Ketek®), or erythromycin
          • Other medicines that treat high blood pressure
          • K antagonists (like coumadin or warfarin)
          • Other medicines or treatments for ED
          • Sildenafil is the same medicine found in VIAGRA® and REVATIO®. REVATIO® is used to treat a rare disease called pulmonary arterial hypertension (PAH). VIAGRA® should not be used with REVATIO® or with other PAH treatments containing sildenafil or any other PDE5 inhibitors (such as Adcirca [tadalafil])

          Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

          What is the FDA-approved use of sildenafil citrate 20 mg tablets?

          Sildenafil citrate 20 mg tablets are the generic version of REVATIO®, prescription medicine used to treat pulmonary hypertension. Sildenafil citrate is also the active ingredient in VIAGRA® (sildenafil citrate 25 mg, 50 mg, and 100 mg tablets), which is FDA approved to treat erectile dysfunction (ED).

          Roman-affiliated doctors may prescribe sildenafil citrate 20 mg tablets for the treatment of ED or premature ejaculation (PE), if they believe in their medical judgment that it is an appropriate course of treatment.

          Please see the Prescribing Information for complete safety information.

          Product names referenced herein are trademarks of their respective owners.