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Staxyn Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Staxyn (vardenafil hydrochloride) Orally Disintegrating Tablets is a muscle relaxer used to treat erectile dysfunction. Common side effects of Staxyn are warmth or redness in your face, neck, or chest, stuffy nose, headache, dizziness, upset stomach, and back pain.
The recommended dosage of Staxyn is one 10 mg tablet taken 60 minutes before sexual activity. Certain antidepressants, antifungal, antibiotic, heart, and blood pressure medications can interact with Staxyn. Tell your doctor all medications you use. Taking a nitrate medicine with Staxyn can cause a sudden and serious decrease in blood pressure. Contact your doctor or seek medical attention if your erection lasts for more than 4 hours. Staxyn is not indicated for women who are of child bearing years and therefore should not be taken if you are pregnant or breastfeeding.
Our Staxyn (vardenafil hydrochloride) Orally Disintegrating Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Staxyn in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away. You could be having a serious side effect of vardenafil.
Stop using vardenafil and call your doctor at once if you have any of these serious side effects:
- sudden vision loss;
- ringing in your ears, or sudden hearing loss;
- chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
- irregular heartbeat;
- swelling in your hands, ankles, or feet;
- shortness of breath;
- vision changes;
- feeling light-headed, fainting;
- penis erection that is painful or lasts 4 hours or longer; or
- seizure (convulsions).
Less serious side effects may include:
- warmth or redness in your face, neck, or chest;
- runny or stuffy nose;
- headache, dizziness;
- upset stomach; or
- back pain.
Read the entire detailed patient monograph for Staxyn (Vardenafil Hydrochloride Orally Disintegrating Tablets) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Staxyn Overview - Patient Information: Side Effects
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Sexual activity may put extra strain on your heart, especially if you have heart problems. If you have heart problems and experience any of these serious side effects while having sex, stop and get medical help right away: severe dizziness, fainting, chest/jaw/left arm pain.
Rarely, sudden decreased vision in one or both eyes (NAION) may occur. This effect may or may not be caused by vardenafil. If this serious problem occurs, stop taking vardenafil and get medical help right away. You have a slightly greater chance of developing NAION if you have heart disease, diabetes, high cholesterol, certain other eye problems ("crowded disk"), high blood pressure, if you are over 50, or if you smoke.
Rarely, a sudden decrease or loss of hearing, sometimes with ringing in the ears and dizziness, may occur. Stop taking vardenafil and get medical help right away if these effects occur.
In the rare event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and get medical help right away, or permanent problems could occur.
Get medical help right away if you have any serious side effects, including: fast/irregular heartbeat, seizures.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Staxyn (Vardenafil Hydrochloride Orally Disintegrating Tablets)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Staxyn FDA Prescribing Information: Side Effects
The following serious adverse reactions with the use of STAXYN (vardenafil) are discussed elsewhere in the labeling:
- Cardiovascular effects [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
- Priapism [see WARNINGS AND PRECAUTIONS]
- QT Prolongation [see WARNINGS AND PRECAUTIONS]
- Effects on eye [see WARNINGS AND PRECAUTIONS]
- Sudden hearing loss [see WARNINGS AND PRECAUTIONS]
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.
STAXYN: Safety of STAXYN was evaluated in two identical multi-national, randomized, double-blind, placebo-controlled trials. In both pivotal studies, enrollment was stratified so that approximately 50% of patients were ≥ 65 years old. Approximately 8% (n=29) were ≥ 75 years old. An integrated analysis of both studies included a total of 355 subjects that received STAXYN compared to 340 subjects that received placebo (mean age was 61.7, range 21.0 to 88.0; 68% White, 5% Black, 6% Asian, 11% Hispanic and 11% Other). The discontinuation rates due to adverse reactions were 1.4% for STAXYN compared to 0.6% for placebo. Table 1 below details the most frequently reported adverse reactions.
Table 1: Adverse drug reactions reported by ≥ 2%
of the patients treated with STAXYN and more frequent on drug than placebo in
|Adverse Drug Reaction||STAXYN
Adverse drug reactions reported in the STAXYN placebo controlled trials were comparable to the adverse drug reactions reported in earlier vardenafil film-coated tablets placebo controlled trials.
All Vardenafil Studies
Vardenafil film-coated tablets and STAXYN has 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 vardenafil film-coated tablets and STAXYN, the discontinuation rate due to adverse events was 1.9% for vardenafil compared to 0.8% for placebo.
Placebo-controlled trials suggested a dose effect in the incidence of some adverse reactions (for example, dizziness, headache, flushing, dyspepsia, nausea, nasal congestion) over the 5 mg, 10 mg, and 20 mg doses of vardenafil film-coated tablets.
The following section identifies additional, less frequent adverse reactions ( < 2%) reported during the clinical development of vardenafil film-coated tablets and STAXYN. 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:
Musculoskeletal: increase in creatine phosphokinase (CPK), increased muscle tone and cramping, myalgia
Skin and appendages: erythema, rash
Urogenital: increase in erection, priapism
The following adverse reactions have been identified during post approval use of vardenafil in the film-coated tablet formulation. 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.
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 and PATIENT INFORMATION].
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.
Seizure, seizure recurrence and transient global amnesia have been reported postmarketing in temporal association with vardenafil.
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 INFORMATION].
Read the entire FDA prescribing information for Staxyn (Vardenafil Hydrochloride Orally Disintegrating Tablets) »
Additional Staxyn Information
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