Levitra Side Effects
Please note - some side effects for Levitra 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).
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For the consumer For the professional
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Side Effects of Levitra - for the consumer
Levitra
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 Levitra:
Seek medical attention right away if any of these SEVERE side effects occur when using Levitra:Dizziness; flushing; headache; heartburn; stuffy or runny nose; upset stomach.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back or muscle pain; chest pain; fainting; prolonged, painful erection; ringing in the ears; severe or persistent dizziness; severe or persistent vision changes; sudden hearing loss.
For the professional
Levitra
Levitra was administered to over 4430 men (mean age 56, range 18-89 years; 81% White, 6% Black, 2% Asian, 2% Hispanic and 9% Other) during controlled and uncontrolled clinical trials worldwide. Over 2200 patients were treated for 6 months or longer, and 880 patients were treated for at least 1 year.
In placebo-controlled clinical trials, the discontinuation rate due to adverse events was 3.4% for Levitra compared to 1.1% for placebo.
When Levitra was taken as recommended in placebo-controlled clinical trials, the following adverse events were reported.
| Adverse Event | Percentage of Patients Reporting Event | |
| Placebo N = 1199 |
Levitra N = 2203 |
|
| Headache | 4% | 15% |
| Flushing | 1% | 11% |
| Rhinitis | 3% | 9% |
| Dyspepsia | 1% | 4% |
| Accidental Injury† | 2% | 3% |
| Sinusitis | 1% | 3% |
| Flu Syndrome | 2% | 3% |
| Dizziness | 1% | 2% |
| Increased Creatine Kinase | 1% | 2% |
| Nausea | 1% | 2% |
Back pain was reported in 2.0% of patients treated with Levitra and 1.7% of patients on placebo.
Placebo-controlled trials suggested a dose effect in the incidence of some adverse events (headache, flushing, dyspepsia, nausea, rhinitis) over the 5 mg, 10 mg, and 20 mg doses of Levitra. The following section identifies additional, less frequent events (<2%) reported during the clinical development of Levitra. Excluded from this list are those events that are infrequent and minor, those events that may be commonly observed in the absence of drug therapy, and those events that are not reasonably associated with the drug.
BODY AS A WHOLE: anaphylactic reaction (including laryngeal edema),
asthenia, face edema, pain
AUDITORY: sudden decrease or loss of hearing, tinnitus
CARDIOVASCULAR: angina pectoris, chest pain, hypertension,
hypotension, myocardial ischemia, myocardial infarction, palpitation,
postural hypotension, syncope, tachycardia
DIGESTIVE: abdominal pain, abnormal liver function tests, diarrhea, dry
mouth, dysphagia, esophagitis, gastritis, gastroesophageal reflux, GGTP
increased, vomiting
MUSCULOSKELETAL: arthralgia, back pain, myalgia, neck pain
NERVOUS: hypertonia, hypesthesia, insomnia, paresthesia, somnolence,
vertigo
RESPIRATORY: dyspnea, epistaxis, pharyngitis
SKIN AND APPENDAGES: photosensitivity reaction, pruritus, rash,
sweating
OPHTHALMOLOGIC: abnormal vision, blurred vision, chromatopsia,
changes in color vision, conjunctivitis (increased redness of the eye), dim
vision, eye pain, glaucoma, photophobia, watery eyes
UROGENITAL: abnormal ejaculation, priapism (including prolonged or
painful erections)
More resources:
Levitra - Includes detailed dosage instructions.
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