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Review Vardenafil Safety Reports submitted to FDA

Total Vardenafil reports: 24.
Vardenafil FDA safety alerts: 2005 2007 .
   Reported hospitalizations: 5.
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FDA Reported Vardenafil Side Effects: headache, ventricular fibrillation, hypertensive crisis, global amnesia, flushing, pulmonary embolism, cerebrovascular accident, detachment of retinal pigment epithelium, nausea, dizziness, retinal detachment.
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Vardenafil Side Effects Report #5662658-9
Health Professional from UNITED KINGDOM reported VARDENAFIL problem on Mar 04, 2008. Male patient, 52 years of age, was diagnosed with erectile dysfunction and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: optic ischaemic neuropathy. VARDENAFIL dosage: unknown. During the same period patient was treated with ASPIRIN, GLICLAZIDE, LACIDIPINE, RAMIPRIL, RIZATRIPTAN BENZOATE. Patient recovered.

Vardenafil Side Effects Report #5624467-6
VARDENAFIL problem was reported by a Pharmacist from UNITED STATES on Feb 11, 2008. Male patient, 72 years of age, was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: palpitations, priapism, syncope. VARDENAFIL dosage: 20MG PRN PO. Patient was hospitalized. Patient recovered.

Vardenafil Side Effects Report #5597987-0
Health Professional from BRAZIL reported VARDENAFIL problem on Jan 17, 2008. Male patient, 31 years of age, weighting 187.4 lb, was diagnosed with erectile dysfunction, migraine and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: dry eye, visual disturbance. VARDENAFIL dosage: AS USED: 5 MG UNIT DOSE: 10 MG. During the same period patient was treated with CLONAZEPAM, TENVIL. Patient recovered.

Vardenafil Side Effects Report #5605689-7
VARDENAFIL problem was reported by a Pharmacist from UNITED STATES on Jan 23, 2008. Male patient, 56 years of age, weighting 184.1 lb, was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: flushing. VARDENAFIL dosage: unknown. Patient recovered.


Vardenafil Side Effects Report #5545464-5
Health Professional from BRAZIL reported VARDENAFIL problem on Nov 29, 2007. Male patient, 31 years of age, weighting 187.4 lb, was diagnosed with erectile dysfunction, migraine and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: dry eye, visual disturbance. VARDENAFIL dosage: AS USED: 5 MG UNIT DOSE: 10 MG. During the same period patient was treated with RIVOTRIL, TENVIL. Patient recovered.

Vardenafil Side Effects Report #5553344-4
VARDENAFIL problem was reported by a Pharmacist from UNITED STATES on Dec 10, 2007. Male patient, 80 years of age, was diagnosed with erectile dysfunction and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: diarrhoea. VARDENAFIL dosage: 20MG PRN PO. Patient recovered.

Vardenafil Side Effects Report #5509061-X
Physician from UNITED KINGDOM reported VARDENAFIL problem on Oct 24, 2006. Male patient, 51 years of age, weighting 187.4 lb, was diagnosed with erectile dysfunction and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: detachment of retinal pigment epithelium. VARDENAFIL dosage: unknown. During the same period patient was treated with VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY. Patient recovered.

Vardenafil Side Effects Report #5512835-2
VARDENAFIL problem was reported by a Pharmacist from UNITED STATES on Nov 08, 2007. Male patient, 72 years of age, weighting 181.9 lb, was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: nausea. VARDENAFIL dosage: unknown. Patient recovered.

Vardenafil Side Effects Report #5518042-1
Physician from SPAIN reported VARDENAFIL problem on Nov 08, 2007. Male patient, 64 years of age, weighting 196.2 lb, was diagnosed with erectile dysfunction, diabetes mellitus, hyperlipidaemia, crohn's disease, hypertension and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: angina pectoris, angina unstable. VARDENAFIL dosage: unknown. During the same period patient was treated with METFORMIN, GEMFIBROZIL, CLAVERSAL, DIOVAN. Patient was hospitalized. Patient recovered.


Vardenafil Side Effects Report #5519292-0
VARDENAFIL problem was reported by a Physician from UNITED KINGDOM on Oct 24, 2006. Male patient, 51 years of age, weighting 187.4 lb, was diagnosed with erectile dysfunction and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: detachment of retinal pigment epithelium. VARDENAFIL dosage: unknown. During the same period patient was treated with VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY, VARDENAFIL ONCE DAILY. Patient recovered.

Vardenafil Side Effects Report #5492915-0
Physician from GERMANY reported VARDENAFIL problem on Oct 18, 2007. Male patient, 63 years of age, weighting 165.3 lb, was diagnosed with erectile dysfunction and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: global amnesia, hypertensive crisis. VARDENAFIL dosage: unknown. During the same period patient was treated with ASPIRIN. Patient was hospitalized. Patient recovered.

Vardenafil Side Effects Report #5386156-5
VARDENAFIL problem was reported by a Health Professional from SWITZERLAND on July 06, 2007. Male patient, 58 years of age, weighting 163.1 lb, was diagnosed with erectile dysfunction, parkinson's disease and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: parkinsonism. VARDENAFIL dosage: unknown. During the same period patient was treated with LEVODOPA, CABERGOLINE, AMITRIPTYLINE. Patient recovered.

Vardenafil Side Effects Report #5386156-5
Health Professional from SWITZERLAND reported VARDENAFIL problem on July 06, 2007. Male patient, 58 years of age, weighting 163.1 lb, was diagnosed with erectile dysfunction, parkinson's disease and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: parkinsonism. VARDENAFIL dosage: unknown. During the same period patient was treated with LEVODOPA, CABERGOLINE, AMITRIPTYLINE. Patient recovered.

Vardenafil Side Effects Report #5763467-2
VARDENAFIL problem was reported by a Pharmacist from UNITED STATES on June 04, 2008. Male patient, 61 years of age, weighting 179.0 lb, was diagnosed with erectile dysfunction and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: feeling abnormal, malaise. VARDENAFIL dosage: 20 MG OTHER PO. Patient recovered.


Vardenafil Side Effects Report #5708478-8
Pharmacist from UNITED STATES reported VARDENAFIL problem on Apr 14, 2008. Male patient, 68 years of age, was diagnosed with erectile dysfunction and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: palpitations, tachycardia, visual disturbance. VARDENAFIL dosage: 10MG ONCE PO. Patient recovered.

Vardenafil Side Effects Report #5291928-1
VARDENAFIL problem was reported by a Pharmacist from UNITED STATES on Apr 06, 2007. Male patient, 68 years of age, weighting 167.1 lb, was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: dizziness. VARDENAFIL dosage: unknown. Patient recovered.

Vardenafil Side Effects Report #5291933-5
Pharmacist from UNITED STATES reported VARDENAFIL problem on Apr 06, 2007. Male patient, 62 years of age, weighting 191.4 lb, was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: malaise, nausea. VARDENAFIL dosage: unknown. Patient recovered.

Vardenafil Side Effects Report #5291951-7
VARDENAFIL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 06, 2007. Male patient, 65 years of age, weighting 179.9 lb, was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: flushing, headache. VARDENAFIL dosage: unknown. Patient recovered.

Vardenafil Side Effects Report #5292058-5
Pharmacist from UNITED STATES reported VARDENAFIL problem on Apr 06, 2007. Male patient, 66 years of age, weighting 187.6 lb, was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: flushing, hyperhidrosis. VARDENAFIL dosage: unknown. Patient recovered.


Vardenafil Side Effects Report #5294382-9
VARDENAFIL problem was reported by a Pharmacist from UNITED STATES on Apr 09, 2007. Male patient, 73 years of age, weighting 177.7 lb, was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: dyspepsia. VARDENAFIL dosage: unknown. Patient recovered.

Vardenafil Side Effects Report #5294392-1
Pharmacist from UNITED STATES reported VARDENAFIL problem on Apr 09, 2007. Male patient, 63 years of age, weighting 215.6 lb, was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: dyspepsia. VARDENAFIL dosage: unknown. Patient recovered.

Vardenafil Side Effects Report #5308148-4
VARDENAFIL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 23, 2007. Male patient, 46 years of age, weighting 125.0 lb, was diagnosed with erectile dysfunction and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: fear, feeling abnormal, feeling hot, heart rate increased, palpitations, sensory loss, suffocation feeling. VARDENAFIL dosage: 1/2 TABLET -5 MG- AS NEEDED PO. Patient recovered.

Vardenafil Side Effects Report #5258420-1
Physician from GERMANY reported VARDENAFIL problem on Mar 05, 2007. Male patient, 63 years of age, weighting 165.3 lb, was diagnosed with erectile dysfunction and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: global amnesia, hypertensive crisis. VARDENAFIL dosage: unknown. During the same period patient was treated with ASPIRIN. Patient was hospitalized. Patient recovered.

Vardenafil Side Effects Report #5265972-4
VARDENAFIL problem was reported by a Physician from GERMANY on Mar 09, 2007. Male patient, 60 years of age, weighting 165.3 lb, was diagnosed with erectile dysfunction and was treated with VARDENAFIL. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. VARDENAFIL dosage: unknown. Patient was hospitalized. Patient recovered.


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