Drug Insights

Is Phexxi approved by the FDA?

2 July 2024
3 min read

Yes, Phexxi is FDA approved. The U.S. Food and Drug Administration (FDA) approved Phexxi on May 22, 2020.

What is Phexxi?

Phexxi, with the generic name citric acid, lactic acid, and potassium bitartrate, is a non-hormonal contraceptive gel used to prevent pregnancy. It works by lowering the pH of the vagina and reducing sperm motility, making it difficult for sperm to reach and fertilize an egg. Phexxi is intended for on-demand use and should be applied just before vaginal sex. It is not effective if used after intercourse.

How Does Phexxi Work?

Phexxi combines lactic acid, citric acid, and potassium bitartrate to create an acidic environment in the vagina, which decreases sperm motility. This on-demand contraceptive method provides an option for women who prefer to avoid hormonal birth control.

Usage and Administration

Phexxi is provided in a prefilled vaginal applicator. Each dose should be inserted into the vagina within one hour before sex. If you have sex more than once in a one-hour period, you must insert another dose. Phexxi can be used at any time during the menstrual cycle and can be used in combination with other contraceptive methods such as condoms, diaphragms, and hormonal contraceptives (except vaginal rings).

Side Effects

Common side effects of Phexxi include:

  • Bladder infections
  • Vaginal burning, itching, or discomfort
  • Vaginal itching or discharge
  • Bacterial or fungal infections in the vagina

Severe side effects may include:

  • Pain or burning when urinating
  • Cloudy urine
  • Pain in the flank, side, or lower back

Precautions

  • Pregnancy: Do not use Phexxi if you are already pregnant.
  • Bladder Infections: Avoid Phexxi if you have a history of frequent bladder infections or other urinary tract problems.
  • Allergies: Inform your doctor if you are allergic to any of the ingredients in Phexxi.
  • Breastfeeding: Consult your doctor as it may not be safe to use Phexxi while breastfeeding.

Storage

Store Phexxi in its foil pouch at room temperature, away from moisture and heat. Use it immediately after opening the pouch.

Conclusion

Phexxi (citric acid, lactic acid, and potassium bitartrate) is an FDA-approved, non-hormonal contraceptive gel that provides on-demand birth control by reducing sperm motility through acidification of the vaginal environment. Approved on May 22, 2020, it offers a hormone-free alternative for women seeking to prevent pregnancy. Always consult with a healthcare provider for personalized advice and to ensure the correct and safe use of Phexxi.

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