Tadagra Side effects

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What are the possible side effects of Tadagra?

Get emergency medical help if you have any signs of an allergic reaction to Tadagra: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Tadagra and get emergency medical help if you have:

Also call your doctor right away if you have:

Common Tadagra side effects may include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Tadagra in details

A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
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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 practice.

Tadagra was administered to over 9000 men during clinical trials worldwide. In trials of Tadagra for once daily use, a total of 1434, 905, and 115 were treated for at least 6 months, 1 year, and 2 years, respectively. For Tadagra for use as needed, over 1300 and 1000 subjects were treated for at least 6 months and 1 year, respectively.

Tadagra For Use As Needed For ED

In eight primary placebo-controlled clinical studies of 12 weeks duration, mean age was 59 years (range 22 to 88) and the discontinuation rate due to adverse events in patients treated with Tadagra 10 or 20 mg was 3.1%, compared to 1.4% in placebo treated patients.

When taken as recommended in the placebo-controlled clinical trials, the following adverse reactions were reported for Tadagra for use as needed:

Table 1: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadagra (10 or 20 mg) and More Frequent on Drug than Placebo in the Eight Primary Placebo- Controlled Clinical Studies (Including a Study in Patients with Diabetes ) for Tadagra for Us e as Needed for ED

Adverse Reaction Placebo

(N=476)

Tadagra 5 mg

(N=151)

Tadagra 10 mg

(N=394)

Tadagra 20 mg

(N=635)

Headache 5% 11% 11% 15%
Dyspepsia 1% 4% 8% 10%
Back pain 3% 3% 5% 6%
Myalgia 1% 1% 4% 3%
Nasal congestion 1% 2% 3% 3%
FlushingThe term flushing includes: facial flushing and flushing

Tadagra For Once Daily Use For ED

In three placebo-controlled clinical trials of 12 or 24 weeks duration, mean age was 58 years (range 21 to 82) and the discontinuation rate due to adverse events in patients treated with Tadagra was 4.1%, compared to 2.8% in placebo-treated patients.

The following adverse reactions were reported in clinical trials of 12 weeks duration:

Table 2: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadagra for Once Daily Us e (2.5 or 5 mg) and More Frequent on Drug than Placebo in the Three Primary Placebo-Controlled Phase 3 Studies of 12 weeks Treatment Duration (Including a Study in Patients with Diabetes ) for Tadagra for Once Daily Us e for ED

Adverse Reaction Placebo

(N=248)

Tadagra 2.5 mg

(N=196)

Tadagra 5 mg

(N=304)

Headache 5% 3% 6%
Dyspepsia 2% 4% 5%
Naso pharyngitis 4% 4% 3%
Back pain 1% 3% 3%
Upper respiratory tract infection 1% 3% 3%
Flushing 1% 1% 3%
Myalgia 1% 2% 2%
Cough 0% 4% 2%
Diarrhea 0% 1% 2%
Nasal congestion 0% 2% 2%
Pain in extremity 0% 1% 2%
Urinary tract infection 0% 2% 0%
Gastroesophageal reflux disease 0% 2% 1%
Abdominal pain 0% 2% 1%

The following adverse reactions were reported over 24 weeks treatment duration in one placebo-controlled clinical study:

Table 3: Treatment-Emergent Adverse Reactions Reported by ≥ 2% of Patients Treated with Tadagra for Once Daily Us e (2.5 or 5 mg) and More Frequent on Drug than Placebo in One Placebo-Controlled Clinical Study of 24 Weeks Treatment Duration for Tadagra for Once Daily Use for ED

Adverse Reaction Placebo

(N=94)

Tadagra 2.5 mg

(N=96)

Tadagra 5 mg

(N=97)

Naso pharyngitis 5% 6% 6%
Gastroenteritis 2% 3% 5%
Back pain 3% 5% 2%
Upper respiratory tract infection 0% 3% 4%
Dyspepsia 1% 4% 1%
Gastroesophageal reflux disease 0% 3% 2%
Myalgia 2% 4% 1%
Hypertension 0% 1% 3%
Nasal congestion 0% 0% 4%

Tadagra For Once Daily Use For BPH And For ED And BPH

In three placebo-controlled clinical trials of 12 weeks duration, two in patients with BPH and one in patients with ED and BPH, the mean age was 63 years (range 44 to 93) and the discontinuation rate due to adverse events in patients treated with Tadagra was 3.6% compared to 1.6% in placebo-treated patients. Adverse reactions leading to discontinuation reported by at least 2 patients treated with Tadagra included headache, upper abdominal pain, and myalgia. The following adverse reactions were reported.

Table 4: Treatment-Emergent Adverse Reactions Reported by ≥ 1% of Patients Treated with Tadagra for Once Daily Use (5 mg) and More Frequent on Drug than Placebo in Three Placebo- Controlled Clinical Studies of 12 Weeks Treatment Duration, including Two Studies for Tadagra for Once Daily Us e for BPH and One Study for ED and BPH

Adverse Reaction Placebo

(N=576)

Tadagra 5 mg

(N=581)

Headache 2.3% 4.1%
Dyspepsia 0.2% 2.4%
Back pain 1.4% 2.4%
Naso pharyngitis 1.6% 2.1%
Diarrhea 1.0% 1.4%
Pain in extremity 0.0% 1.4%
Myalgia 0.3% 1.2%
Dizziness 0.5% 1.0%

Additional, less frequent adverse reactions ( < 1%) reported in the controlled clinical trials of Tadagra for BPH or ED and BPH included: gastroesophageal reflux disease, upper abdominal pain, nausea, vomiting, arthralgia, and muscle spasm.

Back pain or myalgia was reported at incidence rates described in Tables 1 through 4. In Tadagra clinical pharmacology trials, back pain or myalgia generally occurred 12 to 24 hours after dosing and typically resolved within 48 hours. The back pain/myalgia associated with Tadagra treatment was characterized by diffuse bilateral lower lumbar, gluteal, thigh, or thoracolumbar muscular discomfort and was exacerbated by recumbency. In general, pain was reported as mild or moderate in severity and resolved without medical treatment, but severe back pain was reported with a low frequency ( < 5% of all reports). When medical treatment was necessary, acetaminophen or non-steroidal anti-inflammatory drugs were generally effective; however, in a small percentage of subjects who required treatment, a mild narcotic (e.g., codeine) was used. Overall, approximately 0.5% of all subjects treated with Tadagra for on demand use discontinued treatment as a consequence of back pain/myalgia. In the 1-year open label extension study, back pain and myalgia were reported in 5.5% and 1.3% of patients, respectively. Diagnostic testing, including measures for inflammation, muscle injury, or renal damage revealed no evidence of medically significant underlying pathology. Incidence rates for Tadagra for once daily use for ED, BPH and BPH/ED are described in Tables 2, 3 and 4. In studies of Tadagra for once daily use, adverse reactions of back pain and myalgia were generally mild or moderate with a discontinuation rate of < 1% across all indications.

Across placebo-controlled studies with Tadagra for use as needed for ED, diarrhea was reported more frequently in patients 65 years of age and older who were treated with Tadagra (2.5% of patients).

Across all studies with any Tadagra dose, reports of changes in color vision were rare ( < 0.1% of patients).

The following section identifies additional, less frequent events ( < 2%) reported in controlled clinical trials of Tadagra for once daily use or use as needed. A causal relationship of these events to Tadagra is uncertain. Excluded from this list are those events that were minor, those with no plausible relation to drug use, and reports too imprecise to be meaningful:

Body as a Whole - asthenia, face edema, fatigue, pain, peripheral edema

Cardiovascular - angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia

Digestive - abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, GGTP increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage

Musculoskeletal - arthralgia, neck pain

Nervous - dizziness, hypesthesia, insomnia, paresthesia, somnolence, vertigo Renal and Urinary

What is the most important information I should know about Tadagra?

Tadagra contraindications

Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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5 mg Film-coated Tablet: Hypersensitivity to the active substance or to any of the excipients.

In clinical studies, Tadagra was shown to augment the hypotensive effects of nitrates. This is thought to result from the combined effects of nitrates and Tadagra on the nitric oxide/cGMP pathway. Therefore, administration of Tadagra to patients who are using any form of organic nitrate is contraindicated..

Tadagra, must not be used in men with cardiac disease for whom sexual activity is inadvisable. Physicians should consider the potential cardiac risk of sexual activity in patients with pre-existing cardiovascular disease.

20 mg Film-coated Tablet: Nitrates and Tadagra must not be used concomitantly. Co-administration of Tadagra with nitric oxide donors, organic nitrates or organic nitrites in any form either regularly or intermittently is contraindicated. Drugs which must not be used concomitantly include, but are not limited to, glyceryl trinitrate (injection, tablets, sprays or patches), isosorbide salts, sodium nitroprusside, amyl nitrite, nicorandil or organic nitrates in any form. In clinical studies, Tadagra was shown to potentiate the hypotensive effects of both acute and chronic nitrate administration. This is thought to result from the combined effects of nitrates and Tadagra on the nitric oxide/cGMP pathway.

Based on the results of a clinical study in which 150 subjects receiving daily doses of Tadagra 20 mg for 7 days and 0.4 mg sublingual nitroglycerin at various times, this interaction lasted for more than 24 hours and was no longer detectable when 48 hours had elapsed after the last Tadagra dose. Thus, in a patient prescribed Tadagra, where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of Tadagra before nitrate administration is considered. In such circumstances, nitrates should only be administered under close medical supervision with appropriate haemodynamic monitoring.

5 mg and 20 mg Film-coated Tablet: The following groups of patients with cardiovascular disease were not included in clinical trials and the use of Tadagra is therefore contraindicated: Patients with 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; patients with a stroke within the last 6 months.

Tadagra is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.

Tadagra should not be used in patients with a known hypersensitivity to Tadagra or to any ingredient of the tablet.


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References

  1. DailyMed. "TADALAFIL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DTP/NCI. "Tadalafil: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "(6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Tadagra are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Tadagra. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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