Does the FDA approve compounded drugs?

The FDA does not verify the safety or effectiveness of compounded drugs. However, all three drugs in Ristenza’s® patented formula are FDA approved and have a long history of use, safety, and effectiveness for their primary indications. Prescription products require a consultation with a healthcare provider who will determine if Ristenza’s® patented formula is right for you.

Men who use Ristenza’s® patented formula should not consume more than one alcoholic beverage within 6 hours of taking Ristenza’s® patented formula.

As Ristenza’s® patented formula may cause drowsiness, this medication needs to be used with caution if you are intending to drive, operate machinery or perform other hazardous activities.

Possible Side Effects

Some of the possible effects of Ristenza’s® patented formula include: nausea, gastro-intestinal disturbances, drowsiness, dizziness, constipation, headache, vomiting, pruritus/itchiness, agitation, diarrhea, dry mouth, sweating, skin flushing, dyspepsia, prolonged erection, nasal congestion, abnormal or blurred vision, abnormal hearing, decreased memory.

A rare but possible serious side effect of using Ristenza’s® formula is Serotonin Syndrome. This is a constellation of symptoms including fever, high blood pressure, and an irregular heartbeat. This can be life threatening. Men who experience any of the mentioned symptoms should discontinue the use of Ristenza’s® formula and advise their physician immediately.

If you have a current or past medical history of the following, you must consult with a healthcare provider prior to taking Ristenza’s® Patented Formula. 

  • Men with cardiac issues including a history of coronary artery disease, arrhythmias, angina, heart attack, stroke, or pulmonary arterial hypertension.  If you are taking nitrates for chest pain, please clear with your physician prior to taking Ristenza’s® formula.
  • Men with mental disorders, including anxiety, depression, suicidal, opioid, dependence, or alcohol issues.
  • Men with a seizure disorder, epilepsy or increased intercranial pressure. Men with a history of head trauma, should consult with a physician prior to taking Ristenza’s® patented formula.
  • Men currently taking a Monoamine oxidase inhibitor (MAOI).
  • Men with breathing problems, including sleep apnea.
  • Men with liver and/or kidney disease, ulcers and/or abdominal disease
  • Men with visual disturbances. Ristenza’s® formula can decrease blood flow to the optic nerve.
  • Men taking any herbal supplements or recreational drugs.