SIDE EFFECTS
The following are discussed in more detail in other sections of the labeling:
- Cardiovascular [see WARNINGS AND PRECAUTIONS]
- Prolonged Erection and Priapism [see WARNINGS ANDPRECAUTIONS]
- 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 [seeWARNINGS 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 [seeWARNINGS 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) | 50 MG (N=511) | 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 < 2% of patients in controlled clinical trials; a causal relationship to VIAGRA is uncertain. Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful:
Body as a Whole: face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury.
Cardiovascular: angina pectoris, AV block, migraine, syncope, tachycardia, palpitation, hypotension, postural hypotension, myocardial ischemia, cerebralthrombosis, cardiac arrest, heart failure, abnormal electrocardiogram,cardiomyopathy.
Digestive: vomiting, glossitis, colitis, dysphagia, gastritis, gastroenteritis,esophagitis, stomatitis, dry mouth, liver function tests abnormal, rectalhemorrhage, gingivitis.
Metabolic and Nutritional: thirst, edema, gout, unstable diabetes,hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction,hypernatremia.
Musculoskeletal: arthritis, arthrosis, myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis.
Nervous: ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor,vertigo, depression, insomnia, somnolence, abnormal dreams, reflexes decreased, hypesthesia.
Respiratory: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased.
Skin and Appendages: urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis.
Special Senses: sudden decrease or loss of hearing, mydriasis,conjunctivitis, photophobia, tinnitus, eye pain, ear pain, eye hemorrhage,cataract, dry eyes.
Urogenital: cystitis, nocturia, urinary frequency, breast enlargement, urinary incontinence, abnormal ejaculation, genital edema and anorgasmia.
Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking VIAGRA with and without anti-hypertensive medication. This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.
Postmarketing Experience
The following adverse reactions have been identified during post approval use of VIAGRA. 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. These events have been chosen for inclusion either due to their seriousness, reporting frequency, lack of clear alternative causation, or a combination of these factors.
Cardiovascular and Cerebrovascular
Serious cardiovascular, cerebrovascular, and vascular events, includingmyocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension,subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of VIAGRA. 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 VIAGRA without sexual activity. Others were reported to have occurred hours to days after the use of VIAGRA and sexual activity. It is not possible to determine whether these events are related directly to VIAGRA, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors [see WARNINGS AND PRECAUTIONSand PATIENT INFORMATION].
Hemic and Lymphatic: vaso-occlusive crisis: In a small, prematurely terminated study of REVATIO (sildenafil) in patients with pulmonary arterial hypertension (PAH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported in patients who received sildenafil than in those randomized to placebo. The clinical relevance of this finding to men treated with VIAGRA for ED is not known.
Respiratory: epistaxis
Special Senses
Hearing: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including VIAGRA. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of VIAGRA, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [see WARNINGS ANDPRECAUTIONS and PATIENT INFORMATION].
Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increasedintraocular pressure, retinal edema, retinal vascular disease or bleeding, andvitreous traction/detachment.
Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including VIAGRA. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to discratio (“crowded disc”), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors [see WARNINGS ANDPRECAUTIONS and PATIENT INFORMATION].
Urogenital: prolonged erection, priapism [see WARNINGS ANDPRECAUTIONS and PATIENT INFORMATION], and hematuria.
Read the Viagra (sildenafil citrate) Side Effects Center for a complete guide to possible side effects
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