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Revatio

Last reviewed on RxList: 10/28/2016
Revatio Side Effects Center

Last reviewed on RxList 11/18/2016

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. 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.

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. 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. 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.

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.

Revatio Consumer Information

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)

Revatio Professional Information

SIDE EFFECTS

The following serious adverse events are discussed elsewhere in the labeling:

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 [see Clinical Studies].

The overall frequency of discontinuation in REVATIO-treated patients on 20 mg three times a day 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 three times a day) 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 three times a day, %
(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 three times a day, 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 three times a day 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 three times a day 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 and increased to 40 mg and then 80 mg all three times a day) 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 group at least 6% greater than Epoprostenol group)

  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)

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© 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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