Medical Editor: John P. Cunha, DO, FACOEP
What Is Revatio?
Revatio (sildenafil), a cyclic GMP inhibitor, is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability and delay clinical worsening. Revatio is also used to treat erectile dysfunction. Revatio is available as a generic.
What Are Side Effects of Revatio?
Revatio may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- chest pain or pressure,
- pain spreading to your jaw or shoulder,
- nausea,
- sweating,
- vision changes,
- sudden vision loss,
- erection is painful or lasts longer than 4 hours,
- severe shortness of breath,
- cough with foamy mucus,
- ringing in your ears,
- sudden hearing loss,
- irregular heartbeat,
- swelling in your hands, ankles, or feet,
- seizures, and
- lightheadedness
Get medical help right away, if you have any of the symptoms listed above.
Side effects of Revatio include:
- flushing (warmth or redness in your face/neck/chest),
- stuffy nose,
- headache,
- memory problems,
- upset stomach,
- back pain,
- low blood pressure,
- faint feeling,
- dizziness, or
- shortness of breath.
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Revatio
Revatio is available in 20 mg strength tablets. The recommended dose of Revatio is 20 mg three times a day. Revatio should be taken approx. 4-6 hours apart.
What Drugs, Substances, or Supplements Interact with Revatio?
Revatio may interact with similar medications (such as avanafil, tadalafil, or vardenafil), bosentan, cimetidine, conivaptan, imatinib, isoniazid, antidepressants, antibiotics, antifungal medications, drugs to treat high blood pressure or a prostate disorder, heart or blood pressure medications, hepatitis C medications boceprevir or telaprevir, or HIV/AIDS medicines. Tell your doctor all medications and supplements you use.
Revatio During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant during treatment with Revatio; it is not expected to be harmful to a fetus. It is unknown if Revatio passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Additional Information
Our Revatio (sildenafil) 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.
SLIDESHOW
COPD Foods to Boost Your Health - COPD Diet Tips See SlideshowGet 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.
QUESTION
COPD (chronic obstructive pulmonary disease) is the same as adult-onset asthma. See AnswerSIDE EFFECTS
The following serious adverse events are discussed elsewhere in the labeling:
- Hypotension [see WARNINGS AND PRECAUTIONS]
- Vision Loss [see WARNINGS AND PRECAUTIONS]
- Hearing Loss [see WARNINGS AND PRECAUTIONS]
- Priapism [see WARNINGS AND PRECAUTIONS]
Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Disease [see WARNINGS AND PRECAUTIONS]
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 practice.
In a 12-week, placebo-controlled clinical study and an open-label extension study (SUPER-1) in 277 REVATIO-treated adults with PAH (WHO Group I) [see Clinical Studies] the adverse reactions that were reported by at least 10% of REVATIO-treated patients in any dosing group, and were more frequent in REVATIO-treated patients than in placebo-treated patients are shown in Table 1. Adverse reactions were generally transient and mild to moderate in nature. The overall frequency of discontinuation in REVATIO-treated patients was 3% (20 mg and 40 mg three times a day) and 8% (80 mg three times a day). The overall frequency of discontinuation for placebo was 3%.
Table 1: Most Common Adverse Reactions in Patients Treated with REVATIO 20 mg, 40 mg, 80 mg and Placebo three times per day in SUPER-1 (More Frequent in REVATIO-Treated Patients than Placebo-Treated Patients)
| REVATIO 20 mg (n = 69) |
REVATIO 40 mg (n = 67) |
REVATIO 80 mg (n = 71) |
Placebo (n = 70) |
|
| Headache | 46% | 42% | 49% | 39% |
| Flushing | 10% | 9% | 16% | 4% |
| Pain in Limb | 7% | 15% | 9% | 6% |
| Myalgia | 7% | 6% | 14% | 4% |
| Back Pain | 13% | 13% | 9% | 11% |
| Dyspepsia | 13% | 8% | 13% | 7% |
| Diarrhea | 9% | 12% | 10% | 6% |
In a placebo-controlled fixed dose titration study (PACES-1) of REVATIO (starting with recommended dose of 20 mg and increased to 40 mg and then 80 mg all three times a day) as an adjunct to intravenous epoprostenol in patients with PAH, no new safety issues were identified except for edema, which occurred in 25% of subjects in the combined REVATIO + epoprostenol group compared with 13% of subjects in the epoprostenol group [see Clinical Studies].
In a study to assess the effects of multiple doses of REVATIO on mortality in adults with PAH (StudyA1481324), the lower dose 5 mg TID group showed a higher observed number of deaths (all related to underlying disease/disease under study), serious adverse events, and severe adverse events than the 20 mg and 80 mg TID groups [see Clinical Studies]. Overall, the safety data for sildenafil 80 mg TID dose in Study A1481324 was consistent with the established safety profile of sildenafil in previous adult PAH studies.
Pediatric Patients
REVATIO was studied in a total of 234 PAH pediatric patients 1 to 17 years of age in a 16-week, double-blind placebo-controlled study (STARTS-1); 220 patients continued in a longterm extension study (STARTS-2). Erection increased was observed in 9% of patients treated with sildenafil in STARTS-1. No other new adverse reactions were identified in pediatric patients [see Use In Specific Populations].
REVATIO Injection
Adverse events with REVATIO injection were similar to those seen with oral tablets.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of sildenafil (marketed for both PAH and erectile dysfunction). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular Events
In postmarketing experience with sildenafil at doses indicated for erectile dysfunction, serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, pulmonary hemorrhage, and subarachnoid and intracerebral hemorrhages have been reported in temporal association with the use of the drug. 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 sildenafil without sexual activity. Others were reported to have occurred hours to days after use concurrent with sexual activity. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient's underlying cardiovascular disease, or to a combination of these or other factors.
Nervous System
Seizure, seizure recurrence
Ophthalmologic
NAION [see WARNINGS AND PRECAUTIONS, PATIENT INFORMATION].
DRUG INTERACTIONS
Nitrates
Concomitant use of REVATIO with nitrates in any form is contraindicated [see CONTRAINDICATIONS].
Strong CYP3A Inhibitors
Concomitant use of REVATIO with strong CYP3A inhibitors is not recommended [see CLINICAL PHARMACOLOGY].
Moderate-to-Strong CYP3A Inducers
Concomitant use of REVATIO with moderate-to-strong CYP3A inducers (such as bosentan) decreases the sildenafil exposure. Dose up-titration of REVATIO may be needed when initiating treatment with moderate-to-strong CYP3A inducers. Reduce the dose of REVATIO to 20 mg three times a day when discontinuing treatment with moderate-to-strong CYP3A inducers [see CLINICAL PHARMACOLOGY and Clinical Studies].
Read the entire FDA prescribing information for Revatio (Sildenafil Citrate)
© Revatio Patient Information is supplied by Cerner Multum, Inc. and Revatio Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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