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.

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:

Dizziness; flushing; headache; heartburn; nausea; stuffy or runny nose; upset stomach.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast, slow, or irregular heartbeat; memory loss; numbness of an arm or leg; prolonged, painful erection; ringing in the ears; seizures; severe back or muscle pain; severe or persistent dizziness; severe or persistent vision changes; sudden decrease or loss of hearing; sudden decrease or loss of vision in one or both eyes; sudden, severe headache or vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Levitra Side Effects - for the Professional

Levitra

The following serious adverse reactions with the use of Levitra (vardenafil) are discussed elsewhere in the labeling:

1. Cardiovascular Effects [see Contraindications (4.1) and Warnings and Precautions (5.1)]
2. Priapism [see Warnings and Precautions (5.3)]
3. Effects on Eye [see Warnings and Precautions (5.4)]
4. Sudden Hearing Loss [see Warnings and Precautions (5.5)]
5. QT Prolongation [see Warnings and Precautions (5.7)]

6.1 Clinical Studies 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.

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 reactions were reported.

Table 1: Adverse Reactions Reported By ≥2% of Patients Treated with Levitra and More Frequent on Drug than Placebo in Fixed and Flexiblea Dose Randomized, Controlled Trials of 5 mg, 10 mg, or 20 mg Vardenafil

Adverse Reaction	Percentage of Patients Reporting Reactions
	Placebo N = 1199	Levitra N = 2203
Headache	4%	15%
Flushing	1%	11%
Rhinitis	3%	9%
Dyspepsia	1%	4%
Accidental Injuryb	2%	3%
Sinusitis	1%	3%
Flu Syndrome	2%	3%
Dizziness	1%	2%
Increased Creatine Kinase	1%	2%
Nausea	1%	2%

• Flexible dose studies started all patients at Levitra 10 mg and allowed decrease in dose to 5 mg or increase in dose to 20 mg based on side effects and efficacy.
• All the events listed in the above table were deemed to be adverse drug reactions with the exception of accidental injury.

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 reactions (headache, flushing, dyspepsia, nausea, and rhinitis) over the 5 mg, 10 mg, and 20 mg doses of Levitra.

All Vardenafil Studies: Levitra film-coated tablets and vardenafil orally disintegrating tablets have been administered to over 17,000 men (mean age 54.5, range 18–89 years; 70% White, 5% Black, 13% Asian, 4% Hispanic and 8% Other) during controlled and uncontrolled clinical trials worldwide. The number of patients treated for 6 months or longer was 3357, and 1350 patients were treated for at least 1 year.

In the placebo-controlled clinical trials for Levitra film-coated tablets and vardenafil orally disintegrating tablets, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.

The following section identifies additional, less frequent adverse reactions (<2%) reported during the clinical development of Levitra film-coated tablets and vardenafil orally disintegrating tablets. Excluded from this list are those adverse reactions 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: allergic edema and angioedema, feeling unwell, allergic reactions, chest pain

Auditory: tinnitus, vertigo

Cardiovascular: palpitation, tachycardia, angina pectoris, myocardial infarction, ventricular tachyarrhythmias, hypotension

Digestive: nausea, gastrointestinal and abdominal pain, dry mouth, diarrhea, gastroesophageal reflux disease, gastritis, vomiting, increase in transaminases

Musculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia

Nervous: paresthesia and dysesthesia, somnolence, sleep disorder, syncope, amnesia, seizure

Respiratory: dyspnea, sinus congestion

Skin and appendages: erythema, rash

Ophthalmologic: visual disturbance, ocular hyperemia, visual color distortions, eye pain and eye discomfort, photophobia, increase in intraocular pressure, conjunctivitis

Urogenital: increase in erection, priapism

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of Levitra. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to drug exposure.

Ophthalmologic: Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for development of 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. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient’s underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors [see Warnings and Precautions (5.4) and Patient Counseling Information (17.7)].

Visual disturbances including vision loss (temporary or permanent), such as visual field defect, retinal vein occlusion, and reduced visual acuity, have also been reported rarely in postmarketing experience. It is not possible to determine whether these events are related directly to the use of vardenafil.

Neurologic: Seizure, seizure recurrence and transient global amnesia have been reported postmarketing in temporal association with vardenafil.

Otologic: Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of vardenafil, to the patient’s underlying risk factors for hearing loss, a combination of these factors, or to other factors [see Patient Counseling Information (17.8)].

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included flushing (vasodilation) in 11% and dizziness in 2% of patients. Consistent with its known effects on the nitric oxide/cGMP pathway, use of sildenafil has been shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are concurrently taking organic nitrates is considered contraindicated. The following cardiovascular side effects have been associated with the use of sildenafil in less than 2% of patients: angina pectoris, chest pain, hypertension, hypotension, myocardial ischemia, palpitation, postural hypotension, syncope, and tachycardia. Congenital or Acquired QT Prolongation: In a study on the effect of vardenafil on QT interval in 59 healthy males, therapeutic (10 mg) and supratherapeutic (80 mg) doses of vardenafil and the active control moxifloxacin (400 mg) produced similar increases in QTc interval. These observations should be considered in clinical decisions when prescribing vardenafil to patients with known history of QT prolongation or patients who are taking medications known to prolong the QT interval.

Dermatologic

Dermatologic side effects have been reported in less than 2% of patients and include photosensitivity reaction, pruritus, rash, and sweating,

Gastrointestinal

Gastrointestinal side effects have included dyspepsia (4%) and nausea (2%). Less common gastrointestinal complaints have included abdominal pain, diarrhea, dry mouth, dysphagia, esophagitis, gastritis, gastroesophageal reflux and vomiting (less than 2% of patients).

Hepatic

Hepatic side effects have included increased creatine kinase (2%). Other hepatic side effects (less than 2%) have included other abnormal liver function tests.

Genitourinary

Genitourinary side effects have been reported in less than 2% of patients and included abnormal ejaculation and priapism (including prolonged or painful erections). In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Musculoskeletal

Musculoskeletal side effects have been reported in less than 2% of patients. They include arthralgia, back pain, myalgia, and neck pain.

Nervous system

Nervous system side effects have included headache (16%) and dizziness (2%). Other nervous system side effects reported in less than 2% of patients have included hypertonia, hypesthesia, insomnia, paresthesia, somnolence, and vertigo. Seizure and seizure recurrence have been reported postmarketing in temporal association with vardenafil. Transient global amnesia has also been reported postmarketing in temporal association with vardenafil.

Ocular

Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including vardenafil.

Ocular side effects have been reported in less than 2% of patients and have included abnormal vision, blurred vision, chromatopsia, changes in color vision, conjunctivitis, dim vision, eye pain, glaucoma, photophobia, and watery eyes.

Respiratory

Respiratory system side effects have included rhinitis (9%) and sinusitis (3%). Other respiratory system side effects that occurred in more than 2% of patients have included dyspnea, epistaxis, and pharyngitis.

Other

Other side effects have included tinnitus. Cases of sudden decrease or loss of hearing reported postmarketing in temporal association with the use of PDE5 inhibitors, including vardenafil. In some cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of vardenafil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.

General

General side effects have included accidental injury (3%) and flu syndrome (3%). Other side effects occurring in less than 2% of patients include: anaphylactic reaction (including laryngeal edema), asthenia, face edema and pain.

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