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Leuprolide Acetate Depot Side Effects

Common Side Effects

Leuprolide acetate depot has been studied thoroughly in clinical trials in adults and children. In these studies, the side effects that occurred in a group of people taking leuprolide acetate depot were carefully documented and 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 to leuprolide acetate depot in adults included:
  • Hot flashes -- in up to 84 percent of people
  • Injection site reactions -- up to 37.5 percent
  • General pain -- up to 32.7 percent
  • Headache -- up to 32 percent
  • Vaginal dryness, irritation, itching, or discharge -- up to 28 percent
  • Depression or mood swings -- up to 22 percent
  • Swelling in the arms, hands, legs, or feet (edema) -- up to 20.8 percent
  • Testicle atrophy -- up to 20.2 percent
  • Urinary problems -- up to 16.7 percent
  • Joint or muscle pain -- up to 16.3 percent.
Other common side effects, occurring in 1 to 16 percent of people, included:
  • Stomach and intestinal problems (gastrointestinal or GI problems)
  • Nausea and vomiting
  • Weight gain or loss
  • Lack of energy
  • Skin reactions
  • Flu-like symptoms
  • Decreased libido (sex drive)
  • Dizziness
  • Respiratory (breathing) problems
  • Acne
  • Neuromuscular problems (problems with the nerves and muscles)
  • Insomnia
  • Numbness or tingling and pricking sensations of the skin
  • Dehydration
  • Breast tenderness, pain, or enlargement
  • Impotence (erectile dysfunction, or ED)
  • Infection of any kind
  • Nervousness
  • Excessive hair growth in women
  • Memory problems.
Common side effects of leuprolide acetate depot in children included:
  • Injection site reactions -- in up to 9 percent of children
  • Mood changes -- up to 5 percent
  • Vaginal bleeding, irritation, or discharge -- up to 3 percent
  • General pain -- up to 3 percent
  • Headache -- up to 3 percent
  • Acne -- up to 3 percent
  • Rash -- up to 3 percent
  • Vasodilation (widening of the blood vessels), which could cause flushing (sudden redness of the face and neck) -- up to 2 percent.
Last reviewed by: Kristi Monson, PharmD
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