The most common side effects of Invokana include yeast infections and urinary tract infections. The FDA has also received reports of life-threatening infections in the bladder, kidneys, and bloodstream.
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Invokana and Infections
Invokana (canagliflozin) helps control blood-sugar levels by stimulating the kidneys to excrete extra sugar in the urine. Because it increases urine output and relies so heavily on the kidneys, it is not surprising that some of the most common side effects include infections in the bladder and kidneys.
FDA Safety Warning
December 4, 2015 — The FDA has issued a Safety Communication to announce new warnings on the label for Invokana about serious urinary tract infections.
The agency identified 19 cases of life-threatening blood infections (urosepsis) and kidney infections (pyelonephritis) that started as urinary tract infections. All of the patients were hospitalized, and a few required intensive care or dialysis to treat kidney failure.
Yeast infections occur when there is an overgrowth of the fungus Candida, a naturally-occurring microorganism that is normally kept in check by the lactobacillus bacteria.
In clinical trials, about 10% of women on Invokana developed a yeast infection, compared to 3% of women on a placebo. Among men, the risk was 8% for Invokana patients and 2% for a placebo. The study showed the highest risk appears in the first 6 months of treatment.
Vaginal yeast infection symptoms:
- Vaginal odor
- White or yellowish vaginal discharge (may be lumpy or look like cottage cheese)
- Vaginal itching
- Pain during urination or intercourse
Yeast infection symptoms of the penis:
- Redness, itching, or swelling
- Foul-smelling discarge
- Pain in the skin around the penis
Urinary Tract Infections
Urinary Tract Infections (UTIs) are caused by germs that enter the bladder through the urinary tract. Urinary tract infections are the second most-common side effect of Invokana, occurring in about 6% of patients on the 100-mg dose compared to 4% on a placebo in clinical trials.
Symptoms of a urinary tract infection:
- Burning feeling when urinating
- Urinating frequently
- Feeling an urgent need to urinate
- Pain in the lower stomach area (pelvis)
- Blood in the urine
- Back pain
- Nausea or vomiting
Blood Infections (Urosepsis)
Blood infections (urosepsis) occurs when the body has a severe reaction to a bacterial infection. Patients can go into shock, a life-threatening medical emergency in which blood pressure drops and major organ systems stop working because they do not get enough blood or oxygen.
Symptoms of sepsis:
- Fever or low body temperature
- Rapid heartbeat
- Skin rash
- Light-headedness due to low blood pressure
Kidney Infections (Pyelonephritis)
Kidney infections (pyelonephritis) are a rare side effect of Invokana that can occur when a urinary tract infection spreads to the kidneys. Severe infections can permanently scar the kidneys and lead to chronic kidney disease, high blood pressure, or kidney failure.
Symptoms of a kidney infection:
- Back, side, or groin pain
- Frequent, painful urination
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