Drug Name

Cialis (Tadalafil)

Generic Name

Tadalafil (ta-DAL-a-fil)

Looks like

Tadalafil is available with a prescription under the brand name Cialis. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

• Cialis 5 mg-yellow, film-coated, almond-shaped tablets
• Cialis 10 mg-yellow, film-coated, almond-shaped tablets
• Cialis 20 mg-yellow, film-coated, almond-shaped tablets

Dosage Form

Tablets

Route Of Administration

ORAL

Imprint Code

C 5 / C 10 / C 20

Size

10mm / 11mm / 12mm

Alternatives

Impotence
Viagra, Levitra, Yohimbe, Muse, Yohimbine, Alprostadil

Drug Uses

Cialis is an oral drug for male impotence. It works by dilating blood vessels in the penis, allowing the inflow of blood needed for an erection.

Drug class

Cialis is a phosphodiesterase type 5 inhibitor and it works by helping the blood flow into the penis to achieve and maintain an erection during sexual stimulation.

Contains

Cialis is available as film-coated, almond-shaped tablets for oral administration. Each tablet contains 5, 10, or 20 mg of tadalafil and the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron oxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, talc, titanium dioxide, and triacetin.

Chemical formula

Cialis is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
Tadalafil has the empirical formula C22H19N3O4 representing a molecular weight of 389.41.
The chemical designation is pyrazino [1',2':1,6] pyrido [3,4-b] indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a - hexahydro - 2 - methyl - , (6R,12aR)-. It is a crystalline solid that is practically insoluble in water and very slightly soluble in ethanol.

Mechanism of Action

Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cGMP. Tadalafil inhibits PDE5. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation.
Studies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5. PDE5 is found in corpus cavernosum smooth muscle, vascular and visceral smooth muscle, skeletal muscle, platelets, kidney, lung, cerebellum, and pancreas.
In vitro studies have shown that the effect of tadalafil is more potent on PDE5 than on other phosphodiesterases. These studies have shown that tadalafil is>10,000-fold more potent for PDE5 than for PDE1, PDE2, PDE4, and PDE7 enzymes, which are found in the heart, brain, blood vessels, liver, leukocytes, skeletal muscle, and other organs. Tadalafil is>10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels. Additionally, tadalafil is 700-fold more potent for PDE5 than for PDE6, which is found in the retina and is responsible for phototransduction. Tadalafil is >9,000-fold more potent for PDE5 than for PDE8, PDE9, and PDE10. Tadalafil is 14-fold more potent for PDE5 than for PDE11A1 and 40-fold more potent for PDE5 than for PDE11A4, two of the four known forms of PDE11. PDE11 is an enzyme found in human prostate, testes, skeletal muscle and in other tissues. In vitro, tadalafil inhibits human recombinant PDE11A1 and, to a lesser degree, PDE11A4 activities at concentrations within the therapeutic range. The physiological role and clinical consequence of PDE11 inhibition in humans have not been defined.

How Taken

Take tadalafil exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water.
Tadalafil is usually taken when needed before sexual activity. The effects of tadalafil may last for up to 36 hours or more. Your doctor will determine how often you can take tadalafil. Do not take tadalafil more often than is directed by your doctor.
Tadalafil can help achieve an erection when sexual stimulation occurs. An erection will not occur just by taking a pill.
Tadalafil can be taken with or without food.
Tadalafil should not be taken with excessive amounts of alcohol (e.g. 5 or more drinks). Excessive alcohol may increase the risk of headache, dizziness, increased heart rate, or low blood pressure when tadalafil is taken.
If you develop dizziness, nausea, or angina (pain, tightness, discomfort, numbness, or tingling in the chest, arms, neck, or jaw) during sexual activity, refrain from further sexual activity and notify your doctor.
Contact your doctor or seek emergency medical attention for any erection that lasts longer than 4 hours. A sustained erection can damage the penis.
Grapefruit and grapefruit juice may interact with tadalafil. The interaction could lead to potentially adverse effects. You should discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Store this medication at room temperature away from moisture and heat.

Dosage and Administration

The recommended starting dose of Cialis in most patients is 10 mg, taken prior to anticipated sexual activity. The dose may be increased to 20 mg or decreased to 5 mg, based on individual efficacy and tolerability. The maximum recommended dosing frequency is once per day in most patients.
Cialis was shown to improve erectile function compared to placebo up to 36 hours following dosing. Therefore, when advising patients on optimal use of Cialis, this should be taken into consideration. Cialis may be taken without regard to food.

Renal Insufficiency
No dose adjustment is required in patients with mild renal insufficiency. For patients with moderate (creatinine clearance 31 to 50 mL/min) renal insufficiency, a starting dose of 5 mg not more than once daily is recommended, and the maximum dose should be limited to 10 mg not more than once in every 48 hours. For patients with severe (creatinine clearance <30 mL/min) renal insufficiency on hemodialysis, the maximum recommended dose is 5 mg.

Hepatic Impairment
For patients with mild or moderate degrees of hepatic impairment (Child-Pugh Class A or B), the dose of Cialis should not exceed 10 mg once daily. In patients with severe hepatic impairment (Child-Pugh Class C), the use of Cialis is not recommended.

Concomitant Medications
When Cialis is coadministered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating treatment with Cialis, and Cialis should be initiated at the lowest recommended dose.
For patients taking concomitant potent inhibitors of CYP3A4, such as ketoconazole or ritonavir, the maximum recommended dose of Cialis is 10 mg, not to exceed once every 72 hours.

Geriatrics
No dose adjustment is required in patients >65 years of age.

Usual Starting Dose

The recommended starting dose of Cialis in most patients is 10 mg, taken prior to anticipated sexual activity.

Missed Dose

Cialis is used as needed, so you are not likely to miss a dose.

Overdose

Seek emergency medical attention if you think you have used too much of this medicine. Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm ), or emergency room immediately.
Symptoms of a cialis overdose are not known.

Storage

Store Cialis at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Cialis out of the reach of children and away from pets.

How Supplied

Cialis (tadalafil) is supplied as follows:
Three strengths of film-coated, almond-shaped tablets are available in different sizes and different shades of yellow, and supplied in the following package sizes:

5-mg tablets debossed with "C 5"
Bottles of 30 NDC 0002-4462-30

10-mg tablets debossed with "C 10"
Bottles of 30 NDC 0002-4463-30

20-mg tablets debossed with "C 20"
Bottles of 30 NDC 0002-4464-30

What is the most important information I should know about Cialis (Tadalafil)?

A small number of patients have lost eyesight in one eye after taking cialis. This type of vision loss is called non-arteritic anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss of eyesight because blood flow is blocked to the optic nerve. It is not clear at this time if tadalafil causes NAION. NAION also happens in patients who do not take this medicine. People who have a higher chance for NAION include those who:

• have heart disease;
• are over 50 years old;
• have diabetes;
• have high blood pressure;
• have high cholesterol;
• smoke; or
• have certain eye problems.

Stop using cialis if you have any loss in your eyesight and seek medical help right away.
Do not take tadalafil if you are taking any of the following medicines:

• a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur, ISMO, Monoket), and others;
• nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"); or
• an alpha blocker (other than tamsulosin (Flomax) 0.4 mg once a day) such as doxazosin (Cardura), guanadrel (Hylorel), prazosin (Minipress), terazosin (Hytrin), alfuzosin (Uroxatral), and others.

Taking cialis with any of these medications may cause very low blood pressure, possibly resulting in dizziness, fainting, stroke, or heart attack.
Contact your doctor or seek emergency medical attention for any erection that lasts longer than 4 hours. A sustained erection can damage the penis.
Refrain from further sexual activity and notify your doctor it you develop dizziness, nausea, or angina (pain, tightness, discomfort, numbness, or tingling in the chest, arms, neck, or jaw) during sexual activity.
Cialis is usually taken when needed before sexual activity. The effects of cialis may last for up to 36 hours or more. Your doctor will determine how often you can take cialis. Do not take cialis more often than is directed by your doctor.

What should I discuss with my doctor before taking Cialis (Tadalafil)?

Before taking cialis, tell your doctor if you

• have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack;
• have low blood pressure or high blood pressure that is not controlled;
• have had a stroke;
• have liver problems;
• have kidney problems;
• have ever had blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia;
• have a bleeding disorder;
• have a stomach ulcer;
• have retinitis pigmentosa (an inherited condition of the eye);
• have a physical deformity of the penis such as Peyronie's disease;
• had an erection that lasted longer than 4 hours.

You may not be able to take cialis, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
Although cialis is not indicated for use by women, it is in the FDA pregnancy category B. This means that cialis is not expected to be harmful to an unborn baby. Cialis should not be taken by women.
It is not known whether cialis passes into breast milk. Cialis should not be taken by women.
If you are over 65 years of age, you may be more likely to experience side effects from cialis. Your doctor may prescribe a lower dose of this medication.

Absorption

After single oral-dose administration, the maximum observed plasma concentration (Cmax) of tadalafil is achieved between 30 minutes and 6 hours (median time of 2 hours). Absolute bioavailability of tadalafil following oral dosing has not been determined.
The rate and extent of absorption of tadalafil are not influenced by food; thus Cialis may be taken with or without food.

Distribution

The mean apparent volume of distribution following oral administration is approximately 63 L, indicating that tadalafil is distributed into tissues. At therapeutic concentrations, 94% of tadalafil in plasma is bound to proteins.
Less than 0.0005% of the administered dose appeared in the semen of healthy subjects.

Metabolism and Excretion

Tadalafil is predominantly metabolized by CYP3A4 to a catechol metabolite. The catechol metabolite undergoes extensive methylation and glucuronidation to form the methylcatechol and methylcatechol glucuronide conjugate, respectively. The major circulating metabolite is the methylcatechol glucuronide.
Methylcatechol concentrations are less than 10% of glucuronide concentrations. In vitro data suggests that metabolites are not expected to be pharmacologically active at observed metabolite concentrations.

Special Populations

Geriatric

Healthy male elderly subjects (65 years or over) had a lower oral clearance of cialis, resulting in 25% higher exposure (AUC) with no effect on Cmax relative to that observed in healthy subjects 19 to 45 years of age. No dose adjustment is warranted based on age alone. However, greater sensitivity to medications in some older individuals should be considered.

Pediatric

Cialis has not been evaluated in individuals less than 18 years old.

Race

Pharmacokinetic data among various ethnic groups are not available.

Renal Insufficiency

In clinical pharmacology studies using single-dose tadalafil (5 to 10 mg), tadalafil exposure (AUC) doubled in subjects with mild (creatinine clearance 51 to 80 mL/min) or moderate (creatinine clearance 31 to 50 mL/min) renal insufficiency. In subjects with end-stage renal disease on hemodialysis, there was a two-fold increase in Cmax and 2.7- to 4.1-fold increase in AUC following single-dose administration of 10 or 20 mg tadalafil. Exposure to total methylcatechol (unconjugated plus glucuronide) was 2- to 4-fold higher in subjects with renal impairment, compared to those with normal renal function. Hemodialysis (performed between 24 and 30 hours post-dose) contributed negligibly to tadalafil or metabolite elimination. In a clinical pharmacology study (N=28) at a dose of 10 mg, back pain was reported as a limiting adverse event in male patients with moderate renal impairment. At a dose of 5 mg, the incidence and severity of back pain was not significantly different than in the general population. In patients on hemodialysis taking 10- or 20-mg tadalafil, there were no reported cases of back pain. The dose of tadalafil should be limited to 5 mg not more than once daily in patients with severe renal insufficiency or end-stage renal disease. A starting dose of 5 mg not more than once daily is recommended for patients with moderate renal insufficiency; the maximum recommended dose is 10 mg not more than once in every 48 hours. No dose adjustment is required in patients with mild renal insufficiency.

Hepatic Impairment

In clinical pharmacology studies, tadalafil exposure (AUC) in subjects with mild or moderate hepatic impairment (Child-Pugh Class A or B) was comparable to exposure in healthy subjects when a dose of 10 mg was administered. There are no available data for doses higher than 10 mg of tadalafil in patients with hepatic impairment. Insufficient data are available for subjects with severe hepatic impairment (Child-Pugh Class C). Therefore, for patients with mild or moderate hepatic impairment, the maximum dose should not exceed 10 mg, and use in patients with severe hepatic impairment is not recommended.

Possible side effects

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:

Dizziness; flushing; headache; heartburn; mild back or muscle pain; stomach upset; stuffy or runny nose.

Seek medical attention right away if any of these SEVERE side effects occur:

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; prolonged, painful erection; red, swollen, blistered, or peeling skin; ringing in the ears; severe or persistent back or muscle pain; severe or persistent dizziness; severe or persistent vision changes; sudden decrease or loss of vision in one or both eyes; sudden hearing loss.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider.

What other drugs will affect Cialis (Tadalafil)?

Do not take cialis if you are taking any of the following medicines:

• a nitrate such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro, others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), isosorbide mononitrate (Imdur, ISMO, Monoket), and others;
• nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"); or
• an alpha blocker (other than tamsulosin (Flomax) 0.4 mg once a day) such as doxazosin (Cardura), guanadrel (Hylorel), prazosin (Minipress), terazosin (Hytrin), alfuzosin (Uroxatral), and others.

Taking cialis with any of these medications may cause very low blood pressure, possibly resulting in dizziness, fainting, stroke, or heart attack.
Before taking cialis, tell your doctor if you are taking any of the following medications:

• any other drug used to treat impotence, such as sildenafil (Viagra), vardenafil (Levitra), alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others);
• the antibiotic erythromycin (E-Mycin, Eryc, Ery-Tab, others);
• an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral); or
• HIV medications such as indinavir (Crixivan), ritonavir (Norvir), and others.

You may not be able to take cialis, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.
Drugs other than those listed here may also interact with cialis or affect your condition. Talk to your doctor or pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

What should I avoid while taking Cialis (Tadalafil)?

Do not take any other drug used to treat impotence, such as sildenafil (Viagra), vardenafil (Levitra), alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), without first talking to your doctor.
Tadalafil should not be taken with excessive amounts of alcohol (e.g. 5 or more drinks). Excessive alcohol may increase the risk of headache, dizziness, increased heart rate, or low blood pressure when tadalafil is taken.
Grapefruit and grapefruit juice may interact with tadalafil. The interaction could lead to potentially adverse effects. You should discuss the use of grapefruit and grapefruit juice with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Contraindications

Nitrates - Administration of Cialis to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, tadalafil was shown to potentiate the hypotensive effect of nitrates. This is thought to result from the combined effects of nitrates and tadalafil on the nitric oxide/cGMP pathway.
Hypersensitivity - Cialis is contraindicated for patients with a known hypersensitivity to tadalafil or any component of the tablet.

Warnings

Cardiovascular
General - Physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Therefore, treatments for erectile dysfunction, including Cialis, should not be used in men for whom sexual activity is inadvisable as a result of their underlying cardiovascular status.
Left Ventricular Outflow Obstruction - Patients with left ventricular outflow obstruction, (e.g., aortic stenosis and idiopathic hypertrophic subaortic stenosis) can be sensitive to the action of vasodilators, including PDE5 inhibitors.

Patients Not Studied in Clinical Trials
The following groups of patients with cardiovascular disease were not included in clinical safety and efficacy trials for Cialis, and, therefore, the use of Cialis is not recommended in these groups until further information is available:

• patients with a myocardial infarction within the last 90 days;
• patients with unstable angina or angina occurring during sexual intercourse;
• patients with New York Heart Association Class 2 or greater heart failure in the last 6 months;
• patients with uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension (>170/100 mm Hg);
• patients with a stroke within the last 6 months.

In addition, patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in the clinical trials, and use in these patients is not recommended.

Prolonged Erection
There have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for this class of compounds. Priapism, if not treated promptly, can result in irreversible damage to the erectile tissue. Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.

Precautions

Evaluation of erectile dysfunction should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options.
As with other PDE5 inhibitors, tadalafil has mild systemic vasodilatory properties that may result in transient decreases in blood pressure. In a clinical pharmacology study, tadalafil 20 mg resulted in a mean maximal decrease in supine blood pressure, relative to placebo, of 1.6/0.8 mm Hg in healthy subjects. While this effect should not be of consequence in most patients, prior to prescribing Cialis, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects. Patients with significant left ventricular outflow obstruction or severely impaired autonomic control of blood pressure may be particularly sensitive to the actions of vasodilators.
The safety and efficacy of combinations of Cialis and other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.
Cialis should be used with caution in patients who have conditions that might predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia), or in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis, or Peyronie's disease).
When administered in combination with aspirin, tadalafil 20 mg did not prolong bleeding time, relative to aspirin alone. Cialis has not been administered to patients with bleeding disorders or significant active peptic ulceration. Although Cialis has not been shown to increase bleeding times in healthy subjects, use in patients with bleeding disorders or significant active peptic ulceration should be based upon a careful risk-benefit assessment and caution.

Information For Patients

Carcinogenesis/ Mutagenesis/ Impairment of Fertility

Tadalafil was not carcinogenic to rats or mice when administered daily for 2 years at doses up to 400 mg/kg/day. Systemic drug exposures, as measured by AUC of unbound tadalafil, were approximately 10-fold for mice, and 14- and 26-fold for male and female rats, respectively, the exposures in human males given Maximum Recommended Human Dose (MRHD) of 20 mg.
Tadalafil was not mutagenic in the in vitro bacterial Ames assays or the forward mutation test in mouse lymphoma cells. Tadalafil was not clastogenic in the in vitro chromosomal aberration test in human lymphocytes or the in vivo rat micronucleus assays.
There were no effects on fertility, reproductive performance or reproductive organ morphology in male or female rats given oral doses of tadalafil up to 400 mg/kg/day, a dose producing AUCs for unbound tadalafil of 14-fold for males or 26-fold for females the exposures observed in human males given the MRHD of 20 mg. In beagle dogs given tadalafil daily for 3 to 12 months, there was treatment-related non-reversible degeneration and atrophy of the seminiferous tubular epithelium in the testes in 20-100% of the dogs that resulted in a decrease in spermatogenesis in 40-75% of the dogs at doses of ≥10 mg/kg/day. Systemic exposure (based on AUC) at no-observed-adverse-effect-level (NOAEL) (10 mg/kg/day) for unbound tadalafil was similar to that expected in humans at the MRHD of 20 mg.
There were no treatment-related testicular findings in rats or mice treated with doses up to 400 mg/kg/day for 2 years.

Pregnancy

Cialis is not indicated for use in newborns, children, or women.

Nursing Mothers

Tadalafil and/or its metabolites cross the placenta, resulting in fetal exposure in rats. Tadalafil and/or its metabolites were secreted into the milk in lactating rats at concentrations approximately 2.4-fold greater than found in the plasma. Following a single-oral dose of 10 mg/kg, approximately 0.1% of the total radioactive dose was excreted into the milk within 3 hours. It is not known if tadalafil and/or its metabolites is excreted in human breast milk. Use of tadalafil in nursing mothers is not recommended.

Pediatric Use

Pregnancy Category B - There was no evidence of teratogenicity, embryotoxicity, or fetotoxicity in rat or mouse fetuses that received up to 1000 mg/kg/day during the major organ development. Plasma exposure at this dose is approximately 11-fold greater than the AUC values for unbound tadalafil in humans given the MRHD of 20 mg. In a rat prenatal and postnatal development study at doses of 60, 200, and 1000 mg/kg, there was a reduction in postnatal survival of pups. The no-observed-effect-level (NOEL) for maternal toxicity was 200 mg/kg/day and for developmental toxicity was 30 mg/kg/day, which gives approximately 16- and 10-fold exposure multiples, respectively, of the human AUC for the MRHD dose of 20 mg. There are no adequate and well-controlled studies of tadalafil in pregnant women.

Geriatric Use

Approximately 25% of patients in the primary efficacy and safety studies of tadalafil were greater than 65 years of age. No overall differences in efficacy and safety were observed between older and younger patients. No dose adjustment is warranted based on age alone. However, greater sensitivity to medications in some older individuals should be considered.

FDA Alert

[Posted 10/18/2007]
FDA informed healthcare professionals of reports of sudden decreases or loss of hearing following the use of PDE5 inhibitors Viagra, Levitra, Cialis for the treatment of erectile dysfunction, and Revatio for the treatment of pulmonary arterial hypertension. In some cases, the sudden hearing loss was accompanied by tinnitus and dizziness. Medical follow-up on these reports was often limited which makes it difficult to determine if the loss of hearing was related to the use of one of the drugs, an underlying medical condition or other risk factors for hearing loss, a combination of these factors or other factors. The PRECAUTIONS and ADVERSE REACTIONS sections of the approved product labeling for Viagra, Levitra, and Cialis were revised. FDA is working with the manufacturer to revise the labeling for Revatio.

References

References and complaints