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Table 2 Adverse events possibly or probably related to study drug in ≥5% of subjects.

From: Leuprolide Acetate 1-Month Depot for Central Precocious Puberty: Hormonal Suppression and Recovery

 

Number of subjects (%)

COSTART term

Any adverse event

34 (62)

Emotional lability

10 (18)

Injection site pain

8 (15)

Headache

6 (11)

Acne

5 (9)

Pain

4 (7)

Vasodilatationa

4 (7)

Growth retardedb

4 (7)

Vaginitis

4 (7)

Injection site reactionc

3 (5)

Menstrual disorderd

3 (5)

Weight gain

3 (5)

  1. aVasodilation = flushing and/or hot flashes.
  2. bGrowth retarded = slowing of growth.
  3. cInjection site reaction = injection site reaction, injection site hypersensitivity, edema, mass, pain, cyst, atrophy, fibrosis, rash, necrosis, inflammation, abscess, hematoma, granuloma, induration.
  4. dMenstrual disorder = menstrual spotting, vaginal bleeding, and cramping.