CLINICAL TRIALS:
VIAGRA was administered to over 3700 patients (aged 19-87 years) during clinical
trials worldwide. Over 550 patients were treated for longer than one year.
In placebo-controlled clinical studies, the discontinuation rate due to adverse
events for VIAGRA (2.5%) was not significantly different from placebo (2.3%). The
adverse events were generally transient and mild to moderate in nature.
In trials of all designs, adverse events reported by patients receiving VIAGRA were
generally similar. In fixed-dose studies, the incidence of some adverse events increased
with dose. The nature of the adverse events in flexible-dose studies, which more
closely reflect the recommended dosage regimen, was similar to that for fixed-dose
studies.
When VIAGRA was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled
clinical trials, the following adverse events were reported:
Table 2. Adverse Events Reported by ≥2% of Patients Treated With VIAGRA and More
Frequent on Drug Than Placebo in PRN Flexible-Dose Phase II/III Studies
Other adverse reactions occurred at a rate of >2%, but equally common on placebo:
respiratory tract infection, back pain, flu syndrome, and arthralgia.
In fixed-dose studies, dyspepsia (17%) and abnormal vision (11%) were more common
at 100 mg than at lower doses. At doses above the recommended dose range, adverse
events were similar to those detailed above but generally were reported more frequently.
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, cerebral thrombosis,
cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy.
Digestive: vomiting, glossitis, colitis, dysphagia, gastritis, gastroenteritis,
esophagitis, stomatitis, dry mouth, liver function tests abnormal, rectal hemorrhage,
gingivitis.
Hemic and Lymphatic: anemia and leukopenia.
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, deafness, ear pain, eye hemorrhage, cataract, dry
eyes.
Urogenital: cystitis, nocturia, urinary frequency, breast enlargement, urinary
incontinence, abnormal ejaculation, genital edema and anorgasmia.
POST-MARKETING EXPERIENCE:
Cardiovascular and cerebrovascular
Serious cardiovascular, cerebrovascular, and vascular events, including myocardial
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 for further important cardiovascular information).
Special senses:
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 PRECAUTIONS, Information
for Patients).
Other events
Other events reported post-marketing to have been observed in temporal association
with VIAGRA and not listed in the pre-marketing adverse reactions section above
include:
Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia.
Urogenital: prolonged erection, priapism (see WARNINGS) and hematuria.
Special Senses: diplopia, temporary vision loss/decreased vision, ocular
redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased
intraocular pressure, retinal vascular disease or bleeding, vitreous detachment/traction,
paramacular edema and epistaxis.
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 disc ratio ("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 PRECAUTIONS/Information for Patients).