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Home › Drugs by Condition › E › Erectile Dysfunction › Viagra › Side
Effects Print  Save or Share
Viagra Side Effects
===================

Please note - some side effects for Viagra may not be reported. Always
consult your doctor or healthcare specialist for medical advice. You
may also report side effects to the FDA at
http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
Side Effects of Viagra - for the Consumer
-----------------------------------------

Viagra
All medicines may cause side effects, but many people have no, or
minor, side effects. Check with your doctor if any of these most
COMMON side effects persist or become bothersome when using Viagra:

Diarrhea; dizziness; flushing; headache; heartburn; stuffy nose;
upset stomach.
Seek medical attention right away if any of these SEVERE side effects
occur when using Viagra:

Severe allergic reactions (rash; hives; itching; difficulty
breathing; tightness in the chest; swelling of the mouth, face,
lips, or tongue); chest pain; fainting; fast or irregular
heartbeat; memory loss; numbness of an arm or leg; one-sided
weakness; painful or prolonged erection; ringing in the ears;
seizure; severe or persistent dizziness; severe or persistent
vision changes; sudden decrease or loss of hearing; sudden
decrease or loss of vision in one or both eyes.
Top

Viagra Side Effects - for the Professional
------------------------------------------
Viagra

CLINICAL TRIALS
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 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

Adverse Event
Percentage of Patients Reporting Event

Viagra
N=734
PLACEBO
N=725

 
  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.
Headache

16%
4%

Flushing
10%

1%
Dyspepsia

7%
2%

Nasal Congestion
4%

2%
Urinary Tract Infection

3%
2%

Abnormal Vision
3%

0%
Diarrhea

3%
1%

Dizziness
2%

1%
Rash

2%
1%

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, 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.
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.
Other events

Other events reported post-marketing to have been observed in temporal
association with Viagra and not listed in the clinical trial adverse
reactions section above include:
Nervous: seizure, seizure recurrence, anxiety, and transient global
amnesia.

Urogenital: prolonged erection, priapism, 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.
Top

Side Effects by Body System
---------------------------
General

Prior to approval by the FDA, use of sildenafil was evaluated in over
3,700 patients who ranged from 19 to 87 years of age. Over 550
patients were treated for at least 1 year. In placebo-controlled
trials, the rate of discontinuation of therapy due to adverse events
associated with sildenafil averaged 2.5%, which was not significantly
different compared with placebo (2.3%). The incidence of side effects
has been dose-dependent.
Nervous system

Nervous system side effects have included headache, observed in up to
16% of patients. Other nervous system side effects have included
dizziness in 2%, and, in less than 2%: ataxia, hypertonia, neuralgia,
neuropathy, paresthesias, tremor, vertigo, depression, insomnia,
somnolence, abnormal dreams, decreased reflexes, and hypesthesia.
There have been case reports of transient global amnesia and
tonic-clonic seizures. Post marketing experience has included reports
of anxiety, seizure and seizure recurrence.
Cardiovascular

Cardiovascular side effects have included flushing (vasodilation) in
10% and dizziness in 2% of patients. Consistent with its known effects
on the nitric oxide/cGMP pathway, use of sildenafil has been shown to
potentiate the hypotensive effects of nitrates, and its administration
to patients who are concurrently taking organic nitrates is considered
contraindicated. The following cardiovascular side effects have been
associated with the use of sildenafil in less than 2% of patients:
angina pectoris, AV block, migraine, syncope, tachycardia,
palpitation, hypotension, postural hypotension, myocardial ischemia,
cerebral thrombosis, cardiac arrest, heart failure, abnormal
electrocardiogram, chest pain, and cardiomyopathy.
Postmarketing studies have reported serious cardiovascular events,
including myocardial infarction, sudden cardiac death, ventricular
arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, and
hypertension in temporal association with the use of sildenafil. Most
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 the use of sildenafil and sexual activity. It has not
been determined whether these events are related directly to
sildenafil, to sexual activity, to the patient's underlying
cardiovascular disease, to a combination of these factors, or to other
factors.

Gastrointestinal
Gastrointestinal side effects have included dyspepsia (7%) and
diarrhea (3%). Less common gastrointestinal side effects have included
abdominal pain, vomiting, glossitis, colitis, dysphagia, gastritis,
gastroenteritis, esophagitis, stomatitis, dry mouth, abnormal liver
function tests, rectal hemorrhage, and gingivitis. Inhibition of
contractile activity of the esophagus has been reported in patients
receiving sildenafil who have idiopathic achalasia.

Results from a study of patients with idiopathic achalasia given
sildenafil therapy showed inhibition of contractile activity of the
esophageal musculature resulting in decreased lower esophageal
sphincter tone and residual pressure as well as contraction amplitude.
Respiratory

Respiratory system side effects have included nasal congestion (4%).
Other respiratory system side effects have included wheezing, dyspnea,
laryngitis, pharyngitis, sinusitis, bronchitis, increased sputum
production, and cough.
Genitourinary

Genitourinary side effects have included urinary tract infection in 3%
of patients. Less commonly, occurring in less than 2% of patients,
cystitis, nocturia, urinary frequency, breast enlargement, urinary
incontinence, abnormal ejaculation, genital edema, and anorgasmia have
been reported. Prolonged erection greater than 4 hours and priapism
(painful erections greater than 6 hours in duration) have been
reported infrequently since market approval of sildenafil. In the
event of an erection that persists longer than 4 hours, the patient
should seek immediate medical assistance. If priapism is not treated
immediately, penile tissue damage and permanent loss of potency could
result. Acute priapism associated with the use of sildenafil in a
patient with sickle cell trait has been reported.
Ocular

Sildenafil is selective for phosphodiesterase-5 (PDE5). It has lesser
affinity for other PDE isoenzymes, one of which is PDE6, an enzyme
found in the retina. This lower selectivity is thought to be the basis
for abnormalities related to color vision observed with higher doses
or plasma levels.
Nonarteritic anterior ischemic optic neuropathy developed in one eye
within minutes to hours after ingestion of sildenafil. Four of the
five patients had no vascular risk factors for ischemic optic
neuropathy.

Ocular side effects have included mild and transient blue or
colored-tinged vision, sometimes associated with photosensitivity or
blurred vision. Less common ocular side effects (less than 2% of
patients) have included mydriasis, conjunctivitis, photophobia,
tinnitus, eye pain, deafness, ear pain, eye hemorrhage, cataract, and
dry eyes. Several cases of optic neuropathy have been associated with
sildenafil use.
Dermatologic

Dermatologic side effect have included rash which was reported in at
least 2% of patients. Other dermatologic side effects have included
urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact
dermatitis, and exfoliative dermatitis.
Hematologic

Hematologic side effects have included anemia and leukopenia.
Metabolic

Metabolic side effects have included thirst, peripheral and general
edema, gout, hyperglycemia, hypoglycemia (including hypoglycemia
reactions), and hypernatremia.
Other

Other side effects have included facial edema, shock, asthenia, pain,
chills, and accidental falls and injuries.
Musculoskeletal

Musculoskeletal side effects have included arthritis, arthrosis,
myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia, and
synovitis.
Psychiatric

Psychiatric side effects have included anecdotal reports and case
studies of psychological disturbances and aggressive behavior.
Other

Other side effects have included cases of sudden decrease or loss of
hearing reported post-marketing in temporal association with the use
of PDE5 inhibitors, including sildenafil. In some 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 sildenafil, to the
patient's underlying risk factors for hearing loss, a combination of
these factors, or to other factors.
Top

More Viagra resources
---------------------
Viagra Detailed Consumer Information (PDR)

Viagra Prescribing Information (FDA)
Viagra Medfacts Consumer Leaflet (Wolters Kluwer)

Viagra Advanced Consumer (Micromedex) - Includes Dosage
 Information
Viagra Consumer Overview

Revatio Prescribing Information (FDA)
Revatio Medfacts Consumer Leaflet (Wolters Kluwer)

Revatio Detailed Consumer Information (PDR)
Revatio Consumer Overview

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