Staxyn Side Effects

Generic Name: vardenafil

Note: This page contains side effects data for the generic drug vardenafil. It is possible that some of the dosage forms included below may not apply to the brand name Staxyn.

It is possible that some side effects of Staxyn may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to vardenafil: oral tablet, oral tablet disintegrating

As well as its needed effects, vardenafil (the active ingredient contained in Staxyn) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking vardenafil, check with your doctor immediately:

Less common
  • Arm, back, or jaw pain
  • blindness
  • blurred vision
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills
  • cold sweats
  • confusion
  • decreased vision
  • difficult or labored breathing
  • difficulty with swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • eye pain
  • fainting
  • fast, irregular, pounding, or racing heartbeat or pulse
  • headache
  • hives
  • itching
  • nausea
  • nervousness
  • pain or discomfort in the arms, jaw, back, or neck
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • skin rash
  • slow or fast heartbeat
  • sweating
  • tearing
  • tightness in the chest
  • unusual tiredness or weakness
  • vomiting
  • wheezing
Incidence not known
  • Hearing loss

Some vardenafil side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Feeling of warmth and redness of the face, neck, arms, and occasionally, upper chest
  • sneezing
  • stuffy nose
Less common
  • Abnormal ejaculation
  • abdominal or stomach pain
  • abnormal vision
  • acid or sour stomach
  • back pain
  • belching
  • bloody nose
  • body aches or pain
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in color vision
  • changes in vision
  • congestion
  • cough
  • diarrhea
  • difficulty seeing at night
  • difficulty with moving
  • difficulty with swallowing
  • dim vision
  • dry mouth
  • dryness or soreness of the throat
  • excessive muscle tone
  • eye pain
  • face swelling
  • fast heartbeat
  • feeling of constant movement of self or surroundings
  • fever
  • general feeling of discomfort or illness
  • heartburn
  • hoarseness
  • increased redness of the eye
  • increased sensitivity of the eyes to sunlight
  • indigestion
  • itching skin
  • joint pain
  • lack or loss of strength
  • loss of appetite
  • muscle aches and pains
  • muscle cramping
  • muscle stiffness
  • muscle tension or tightness
  • neck pain
  • pain
  • pain or burning in the throat
  • runny nose
  • sensation of spinning
  • shivering
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sore throat
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • stomach discomfort, upset, or pain
  • swollen joints
  • tender, swollen glands in the neck
  • tenderness in the stomach area
  • trouble with sleeping
  • trouble with swallowing
  • unable to sleep
  • voice changes
  • watery eyes

For Healthcare Professionals

Applies to vardenafil: oral tablet, oral tablet disintegrating


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 (the active ingredient contained in Staxyn) 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 side effects have been reported in less than 2% of patients and include photosensitivity reaction, pruritus, rash, and sweating,


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


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 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 (the active ingredient contained in Staxyn) Transient global amnesia has also been reported postmarketing in temporal association with vardenafil.


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 (the active ingredient contained in Staxyn)

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 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 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 (the active ingredient contained in Staxyn) 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 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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