Viagra

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Viagra (sildenafil) is a phosphodiesterase-5 (PDE5) inhibitor used for the treatment of erectile dysfunction. Side effects of Viagra include:

  • warmth or redness in the face, neck, or chest,
  • stuffy nose,
  • headaches,
  • stomach pain,
  • upset stomach,
  • nausea,
  • diarrhea,
  • memory problems,
  • back pain,
  • an inability to differentiate between the colors green and blue,
  • loss of hearing,
  • ringing in the ears,
  • and dizziness.

The recommended dose of Viagra is 25-100 mg taken 30 minutes to 4 hours before sexual activity. Viagra may interact with similar medications [such as avanafil (Stendra), tadalafil (Cialis) or vardenafil (Levitra)], bosentan, cimetidine, conivaptan, imatinib, isoniazid, antidepressants, antibiotics, antifungals, drugs to treat high blood pressure or a prostate disorder, heart or blood pressure medications, hepatitis C medications, or HIV/AIDS medicines. Tell your doctor all medications and supplements you use. Viagra is intended for use in men, and is unlikely to be used in women who are pregnant or breastfeeding. However, Viagra is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Viagra. It is unknown if Viagra passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

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.

SL >Erectile Dysfunction (ED) Causes and Treatment See Slideshow

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking sildenafil and get emergency medical help if you have:

  • heart attack symptoms–chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • vision changes or sudden vision loss; or
  • erection is painful or lasts longer than 4 hours (prolonged erection can damage the penis).

Call your doctor at once if you have:

  • severe shortness of breath, cough with foamy mucus;
  • ringing in your ears, or sudden hearing loss;
  • irregular heartbeat;
  • swelling in your hands, ankles, or feet;
  • a seizure; or (convulsions); or
  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • flushing (warmth, redness, or tingly feeling);
  • headache, dizziness;
  • abnormal vision (blurred vision, changes in color vision)
  • runny or stuffy nose, nosebleeds;
  • sleep problems (insomnia);
  • muscle pain, back pain; or
  • upset stomach.

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)

QUESTION

S >The following are discussed in more detail in other sections of the labeling:

  • Cardiovascular [see WARNINGS AND PRECAUTIONS]
  • Prolonged Erection and Priapism [see WARNINGS AND PRECAUTIONS]
  • Effects on the Eye [see WARNINGS AND PRECAUTIONS]
  • Hearing Loss [see WARNINGS AND PRECAUTIONS]
  • Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see WARNINGS AND PRECAUTIONS]
  • Adverse Reactions with the Concomitant Use of Ritonavir [see WARNINGS AND PRECAUTIONS]
  • Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see WARNINGS AND PRECAUTIONS]
  • Effects on Bleeding [see WARNINGS AND PRECAUTIONS]
  • Counseling Patients About Sexually Transmitted Diseases [see WARNINGS AND PRECAUTIONS]

The most common adverse reactions reported in clinical trials ( > 2%) are headache, flushing, dyspepsia, abnormal vision, nasal congestion, back pain, myalgia, nausea, dizziness, and rash.

Clinical Trials 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 clinical practice.

VIAGRA 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 reactions for VIAGRA (2.5%) was not significantly different from placebo (2.3%).

In fixed-dose studies, the incidence of some adverse reactions increased with dose. The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed-dose studies. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.

Table 1: Adverse Reactions Reported by ≥ 2% of Patients Treated with VIAGRA and More Frequent than Placebo in Fixed-Dose Phase II/III Studies

Adverse Reaction 25 mg
(n=312)
100 mg
(n=506)
Placebo
(n=607)
Headache 16% 21% 28% 7%
Flushing 10% 19% 18% 2%
Dyspepsia 3% 9% 17% 2%
Abnormal vision† 1% 2% 11% 1%
Nasal congestion 4% 4% 9% 2%
Back pain 3% 4% 4% 2%
Myalgia 2% 2% 4% 1%
Nausea 2% 3% 3% 1%
Dizziness 3% 4% 3% 2%
Rash 1% 2% 3% 1%
†Abnormal Vision: Mild to moderate in severity and transient, predominantly color tinge to vision, but also increased sensitivity to light, or blurred vision.

When VIAGRA was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials of two to twenty-six weeks duration, patients took VIAGRA at least once weekly, and the following adverse reactions were reported:

Table 2: Adverse Reactions Reported by ≥ 2% of Patients Treated with VIAGRA and More Frequent than Placebo in Flexible-Dose Phase II/III Studies

Adverse Reaction VIAGRA
N=734
PLACEBO
N=725
Headache 16% 4%
Flushing 10% 1%
Dyspepsia 7% 2%
Nasal Congestion 4% 2%
Abnormal Vision† 3% 0%
Back pain 2% 2%
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.

The following events occurred in

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© Viagra Patient Information is supplied by Cerner Multum, Inc. and Viagra Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

SL >Erectile Dysfunction (ED) Causes and Treatment See Slideshow

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