Revatio
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Revatio
Revatio Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Revatio (sildenafil), a cyclic GMP inhibitor, is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability and delay clinical worsening. Also used to treat erectile dysfunction. Revatio may be available as a generic after September, 2012. Some of the side effects of Revatio may include but are not limited to low blood pressure and may cause faint feeling or dizziness, shortness of breath.
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. Use of Revatio with nitrates in any form is contraindicated. Use of Revatio with ritonavir and other potent CYP3A inhibitors is not advised. Use caution when co-administering alpha-blockers with Revatio because of additive blood pressure-lowering effects. No adequate and well-controlled studies of sildenafil in pregnant women. Revatio should be used during pregnancy only if clearly needed. Caution should be exercised when Revatio is given to nursing women.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Revatio in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of sildenafil.
Stop using sildenafil and call your doctor at once if you have a serious side effect such as:
- sudden vision loss;
- ringing in your ears, or sudden hearing loss;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- irregular heartbeat;
- swelling in your hands, ankles, or feet;
- shortness of breath;
- vision changes;
- feeling light-headed, fainting; or
- penis erection that is painful or lasts 4 hours or longer.
Less serious side effects may include:
- warmth or redness in your face, neck, or chest;
- stuffy nose;
- headache;
- memory problems;
- upset stomach; or
- back pain.
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 Revatio (Sildenafil Citrate) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Revatio Overview - Patient Information: Side Effects
To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Rarely, a sudden loss of eyesight in one or both eyes (NAION) may occur. This may or may not be due to sildenafil. Get medical help right away if this occurs. You have a slightly greater chance of developing this serious eye problem if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), or high blood pressure, or if you smoke or are over 50.
For males, in the unlikely event you have a painful or prolonged erection lasting 4 or more hours, get medical help right away or permanent problems could occur.
Rarely, sildenafil may cause sudden hearing problems (such as decrease/loss of hearing in one or both ears, ringing in the ears). Get medical help right away if these effects occur.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Revatio (Sildenafil Citrate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Revatio FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
The following serious adverse events are discussed elsewhere in the labeling:
- Mortality with pediatric use [see WARNINGS AND PRECAUTIONS and Use In Specific Populations]
- 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 [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.
Safety data of REVATIO in adults were obtained from the 12-week, placebo-controlled clinical study (Study 1) and an open-label extension study in 277 REVATIO-treated patients with PAH, WHO Group I Diagnostic Classification [see Clinical Studies].
The overall frequency of discontinuation in REVATIO-treated patients 20 mg TID was 3% and was the same for the placebo group.
In Study 1, the adverse reactions that were reported by at least 3% of REVATIO-treated patients (20 mg TID) 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.
Table 1. Most Common Adverse Reactions in Patients with PAH
in Study 1 (More Frequent in REVATIO-Treated Patients than Placebo-Treated Patients
and Incidence ≥ 3% in REVATIO-Treated Patients)
| Placebo, % (n = 70) |
REVATIO 20 mg TID, % (n = 69) |
Placebo-Subtracted, % | |
| Epistaxis | 1 | 9 | 8 |
| Headache | 39 | 46 | 7 |
| Dyspepsia | 7 | 13 | 6 |
| Flushing | 4 | 10 | 6 |
| Insomnia | 1 | 7 | 6 |
| Erythema | 1 | 6 | 5 |
| Dyspnea exacerbated | 3 | 7 | 4 |
| Rhinitis | 0 | 4 | 4 |
| Diarrhea | 6 | 9 | 3 |
| Myalgia | 4 | 7 | 3 |
| Pyrexia | 3 | 6 | 3 |
| Gastritis | 0 | 3 | 3 |
| Sinusitis | 0 | 3 | 3 |
| Paresthesia | 0 | 3 | 3 |
At doses higher than the recommended 20 mg TID, there was a greater incidence of some adverse reactions including flushing, diarrhea, myalgia and visual disturbances. Visual disturbances were identified as mild and transient, and were predominately color-tinge to vision, but also increased sensitivity to light or blurred vision.
The incidence of retinal hemorrhage with REVATIO 20 mg TID was 1.4% versus 0% placebo and for all REVATIO doses studied was 1.9% versus 0% placebo. The incidence of eye hemorrhage at both 20 mg TID and at all doses studied was 1.4% for REVATIO versus 1.4% for placebo. The patients experiencing these reactions had risk factors for hemorrhage including concurrent anticoagulant therapy.
In a placebo-controlled fixed dose titration study (Study 2) of REVATIO (starting with recommended dose of 20 mg TID and increased to 40 mg TID and then 80 mg TID) as an adjunct to intravenous epoprostenol in patients with PAH, the adverse reactions that were more frequent in the REVATIO + epoprostenol group than in the epoprostenol group (greater than 6% difference) are shown in Table 2 [see Clinical Studies].
Table 2. Adverse Reactions (%) in patients with PAH in Study
2 (incidence in REVATIO + Epoprostenol ffrouo at least 6% greater than Eooorostenol
erouo)
| REVATIO + Epoprostenol (n=134) |
Epoprostenol (n=131) |
(REVATIO + Epoprostenol) minus Epoprostenol |
|
| Headache | 57 | 34 | 23 |
| Edema^ | 25 | 13 | 14 |
| Dyspepsia | 16 | 2 | 14 |
| Pain in extremity | 17 | 6 | 11 |
| Diarrhea | 25 | 18 | 7 |
| Nausea | 25 | 18 | 7 |
| Nasal congestion | 9 | 2 | 7 |
| ^includes peripheral edema | |||
REVATIO Injection
REVATIO injection was studied in a 66-patient, placebo-controlled study in patients with PAH at doses targeting plasma concentrations between 10 and 500 ng/mL (up to 8 times the exposure of the recommended dose). 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
Read the entire FDA prescribing information for Revatio (Sildenafil Citrate) »
Additional Revatio Information
Revatio - User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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