ADVERSE REACTIONS

The safety of sildenafil tablets is unknown in patients with bleeding disorders and patients with active peptic ulceration.

Aspect	Details	Notes
Generic Name	Sildenafil citrate	Active ingredient
Brand Names	Viagra, Kamagra, others	Marketed under various names
Tablet Strength	25 mg	Dosage per tablet
Form	Oral tablet	Administration form
Manufacturer	Various pharmaceutical companies	Production sources

The use of sildenafil tablets offers no protection against sexually transmitted diseases. 6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling:Cardiovascular [see Warnings and Precautions (5.1)]Prolonged Erection and Priapism [see Warnings and Precautions (5.2)]Effects on the Eye [see Warnings and Precautions (5.3)]Hearing Loss [see Warnings and Precautions (5.4)]Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5)]Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6)]Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)]Effects on Bleeding [see Warnings and Precautions (5.8)]Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions(5.9)]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.6.1 Clinical Trials ExperienceBecause 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.Sildenafil tablets 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 sildenafil tablets (2.5%) was not significantly different from placebo (2.3%).In fixed-dose studies, the incidence of some adverse reactions increased with dose.

• This dose is often prescribed for sensitive individuals or beginners.
• Sildenafil 25mg may start working within 30 minutes of ingestion.
• It’s important to follow prescribed dosage instructions carefully.
• Sildenafil can interact with medications like nitrates.
• Avoid grapefruit juice, as it can increase drug levels.
• The pill should be swallowed whole with water.

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.When sildenafil tablets 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 sildenafil tablets at least once weekly, and the following adverse reactions were reported:The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil tablets is uncertain. This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil tablets.

5.9 Counseling Patients about Sexually Transmitted Diseases

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 cerebrovascularSerious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient sildenafil pick up ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil tablets. Most, but not all, of these patients had preexisting cardiovascular risk factors.

Product	Dosage	Quantity + Bonus	Price
Viagra Generic	25mg	20 Pills	37.74€ 35.94€	Buy
Kamagra Oral Jelly	100mg	110 + 9 Sachets	334.87€ 318.92€	Buy
Kamagra	100mg	12 Pills	55.64€ 52.99€	Buy
Viagra Generic	25mg	270 + 8 Pills	184.26€ 175.49€	Buy
Kamagra Polo	100mg	12 Pills	60.21€ 57.34€	Buy
Kamagra Oral Jelly	100mg	63 + 7 Sachets	224.18€ 213.50€	Buy
Viagra Generic	50mg	90 + 6 Pills	107.37€ 102.26€	Buy
Viagra Generic	150mg	20 Pills	55.02€ 52.40€	Buy
Viagra Generic	150mg	30 + 2 Pills	72.32€ 68.88€	Buy
Viagra Generic	50mg	30 + 4 Pills	54.26€ 51.68€	Buy
Kamagra Oral Jelly	100mg	30 + 5 Sachets	136.20€ 129.71€	Buy
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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 tablets without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil tablets and sexual activity. It is not possible to determine whether these events are related directly to sildenafil tablets, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors [ see Warnings and Precautions (5.1)and Patient Counseling Information (17)].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 sildenafil tablets for ED is not known.Nervous:seizure, seizure recurrence, anxiety, and transient global amnesia.Respiratory:epistaxisSpecial senses:Hearing:Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil tablets. 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 sildenafil oral jelly 100mg 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 tablets, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4)and Patient Counseling Information (17)].Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous 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 sildenafil tablets. 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 [ see Warnings and Precautions (5.3)and Patient Counseling Information (17)].Urogenital:prolonged erection, priapism [ see Warnings and Precautions (5.2)and Patient Counseling Information (17)], and hematuria. The following are discussed in more detail in other sections of the labeling: Cardiovascular [see Warnings and Precautions (5.1)] Prolonged Erection and Priapism [see Warnings and Precautions (5.2)] Effects on the Eye [see Warnings and Precautions (5.3)] Hearing Loss [see Warnings and Precautions (5.4)] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5)] Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6)] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)] Effects on Bleeding [see Warnings and Precautions (5.8)] Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions(5.9)] 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. 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.

Stronger erections, better sex

Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking sildenafil tablets with and without anti-hypertensive medication. This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions. The following adverse reactions have been identified during post approval use of sildenafil tablets. 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.

Serious Side Effects

Sildenafil tablets 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 sildenafil tablets (2.5%) was not significantly different from placebo (2.3%). In fixed-dose studies, the incidence sildenafil oral solution of some adverse reactions increased with dose. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.

Adverse effects

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 tablets without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil tablets and sexual activity. It is not possible to determine whether these events are related directly to sildenafil tablets, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors [ see Warnings and Precautions (5.1)and Patient Counseling Information (17)].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 sildenafil tablets for ED is not known.Nervous:seizure, seizure recurrence, anxiety, and transient global amnesia.Respiratory:epistaxisSpecial senses:Hearing:Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including sildenafil tablets. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events.

Common Side Effects

In many sildenafil oral jelly 100mg 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 tablets, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors [ see Warnings and Precautions (5.4)and Patient Counseling Information (17)].Ocular: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal edema, retinal vascular disease or bleeding, and vitreous 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 sildenafil tablets. 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 [ see Warnings and Precautions (5.3)and Patient Counseling Information (17)].Urogenital:prolonged erection, priapism [ see Warnings and Precautions (5.2)and Patient Counseling Information (17)], and hematuria. The following are discussed in more detail in other sections of the labeling: Cardiovascular [see Warnings and Precautions (5.1)] Prolonged Erection and Priapism [see Warnings and Precautions (5.2)] Effects on the Eye [see Warnings and Precautions (5.3)] Hearing Loss [see Warnings and Precautions (5.4)] Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5)] Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6)] Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)] Effects on Bleeding [see Warnings and Precautions (5.8)] Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions(5.9)] 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. 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. When sildenafil tablets 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 sildenafil tablets at least once weekly, and the following adverse reactions were reported: The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil tablets 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. Metabolic and Nutritional:thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia. 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.

Usual Geriatric Dose for Erectile Dysfunction

The safety of sildenafil tablets is unknown in patients with bleeding disorders and patients with active peptic ulceration. The use of sildenafil tablets offers no protection against sexually transmitted diseases. 6 ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling:Cardiovascular [see Warnings and Precautions (5.1)]Prolonged Erection and Priapism [see Warnings and Precautions (5.2)]Effects on the Eye [see Warnings and Precautions (5.3)]Hearing Loss [see Warnings and Precautions (5.4)]Hypotension when Co-administered with Alpha-blockers or Anti-hypertensives [see Warnings and Precautions (5.5)]Adverse Reactions with the Concomitant Use of Ritonavir [see Warnings and Precautions (5.6)]Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies [see Warnings and Precautions (5.7)]Effects on Bleeding [see Warnings and Precautions (5.8)]Counseling Patients About Sexually Transmitted Diseases [see Warnings and Precautions(5.9)]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.6.1 Clinical Trials ExperienceBecause 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.Sildenafil tablets 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 sildenafil tablets (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.

Most Asked Questions

At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.When sildenafil tablets 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 sildenafil tablets at least once weekly, and the following adverse reactions were reported:The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil tablets is uncertain. This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.6.2 Postmarketing ExperienceThe following adverse reactions have been identified during post approval use of sildenafil tablets. 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 cerebrovascularSerious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient sildenafil pick up ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of sildenafil tablets. Most, but not all, of these patients had preexisting cardiovascular risk factors. Analysis of the safety database from controlled clinical trials showed no apparent difference in adverse reactions in patients taking sildenafil tablets with and without anti-hypertensive medication.

• Sildenafil 25mg is sometimes used off-label for other conditions.
• Login into your doctor’s advice before adjusting your dose.
• Take tablets with water; avoid crushing or chewing them.
• The effects of sildenafil last from 4 to 6 hours.
• It is not an aphrodisiac and requires sexual arousal for effectiveness.
• Regular health check-ups are recommended during use.

This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions. The following adverse reactions have been identified during post approval use of sildenafil tablets. 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.

What other drugs will affect sildenafil?

Sildenafil tablets 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 sildenafil tablets (2.5%) was not significantly different from placebo (2.3%). In fixed-dose studies, the incidence sildenafil oral solution of some adverse reactions increased with dose. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 1 below but generally were reported more frequently.

Missed Dose

When sildenafil tablets 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 sildenafil tablets at least once weekly, and the following adverse reactions were reported: The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to sildenafil tablets 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. Metabolic and Nutritional:thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia. 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.