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Leuprolide Side Effects

Possible Side Effects

Leuprolide has been studied thoroughly in clinical trials in adults and children. In these studies, the side effects that occurred in a group of people using leuprolide were carefully documented and (in some studies) compared to another group of people taking a different medication or placebo (an injection with no active ingredient). As a result, it was possible to see what side effects occurred, how often they appeared, and how they compared to the other groups.
In these studies, common reactions in adults included:
  • Hot flashes -- in up to 84.0 percent of people
  • Injection site reactions, including mild pain, burning, or stinging -- up to 37.5 percent
  • General body pain -- up to 32.7 percent
  • Headache -- up to 32 percent
  • Vaginal dryness, irritation, itching, or discharge -- up to 28.0 percent
  • Depression or emotional lability (mood changes) -- up to 22.0 percent
  • Swelling in the arms, hands, legs, or feet (edema) -- up to 20.8 percent
  • Decreased testicle size -- up to 20.2 percent
  • Fatigue and general discomfort -- up to 17.5 percent
  • Urinary problems -- up to 16.7 percent
  • Joint or muscle pain -- up to 16.3 percent.
Other common reactions, occurring in 1 to 16 percent of people, included:
  • Constipation or diarrhea
  • Nausea and vomiting
  • Weight gain or loss
  • Flu-like symptoms
  • Impotence (erectile dysfunction, or ED) or decreased libido (sex drive)
  • Dizziness
  • Clamminess
  • Shortness of breath
  • Acne
  • Neuromuscular problems (problems with the nerves and muscles)
  • Insomnia
  • Numbness, tingling, or pricking sensations of the skin
  • Dehydration
  • Breast tenderness, pain, or enlargement
  • Infection of any kind
  • Excessive hair growth in women
  • Memory problems
  • High blood pressure (hypertension)
  • Decreased appetite
  • A frequent or urgent need to urinate
  • Bone pain
  • Sinus congestion
  • Change in taste.
Common side effects of leuprolide in children included:
  • Injection site reactions (such as burning, itching, redness, or swelling) -- in up to 9.0 percent of children
  • Mood changes -- up to 5.0 percent
  • Vaginal bleeding, irritation, or discharge -- up to 3.1 percent
  • Acne or flaky skin -- up to 3.1 percent
  • General body pain -- up to 3.0 percent
  • Headache -- up to 3.0 percent
  • Rash -- up to 3.0 percent
  • Vasodilation (widening of the blood vessels), which could cause flushing (sudden redness of the face and neck) -- up to 2.1 percent.
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Leuprolide Acetate Drug Information

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