Lupron Depot Pediatric

Lupron Pediatric Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lupron Depot Pediatric (leuprolide acetate) is used to treat precocious (early-onset) puberty in both male and female children. It is a manmade form of a gonadotropin-releasing hormone (GnRH or LH-RH). Common side effects include acne, increased growth of facial hair, breakthrough bleeding in a female child during the first 2 months of treatment, dizziness, weakness, tired feeling, hot flashes, night sweats, chills, clammy skin, nausea, diarrhea, constipation, stomach pain, skin redness, itching, or scaling, joint or muscle pain, vaginal itching or discharge, breast swelling or tenderness, testicle pain, impotence, loss of interest in sex, depression, insomnia, memory problems, or redness, burning, itching, or swelling where the shot was given.

Lupron Depot Pediatric is administered under the supervision of a physician, and is given as a single intramuscular injection once a month. The starting dose is dictated by the child's weight. Other drugs may interact with Lupron Depot. Tell your doctor all medications and supplements you use. Do not use Lupron Depot if you are pregnant. It can cause birth defects. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception may not be effective in preventing pregnancy while using this drug. Breastfeeding while using Lupron Depot is not recommended.

Our Lupron Depot Pediatric (leuprolide acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lupron Pediatric in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • bone pain, loss of movement in any part of your body;
  • swelling, rapid weight gain;
  • pain, burning, stinging, bruising, or redness where the medication was injected;
  • feeling like you might pass out;
  • sudden chest pain or discomfort, wheezing, dry cough or hack;
  • painful or difficult urination;
  • urinating more often than usual;
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
  • sudden numbness or weakness (especially on one side of the body), problems with speech or balance;
  • sudden headache with vision problems, vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing; or
  • chest pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Rare but serious side effects may include:

  • pain or unusual sensations in your back;
  • numbness, weakness, or tingly feeling in your legs or feet;
  • muscle weakness or loss of use;
  • loss of bowel or bladder control; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • acne, increased growth of facial hair;
  • breakthrough bleeding in a female child during the first 2 months of leuprolide treatment;
  • dizziness, weakness, tired feeling;
  • hot flashes, night sweats, chills, clammy skin;
  • nausea, diarrhea, constipation, stomach pain;
  • skin redness, itching, or scaling;
  • joint or muscle pain;
  • vaginal itching or discharge;
  • breast swelling or tenderness;
  • testicle pain;
  • impotence, loss of interest in sex;
  • depression, sleep problems (insomnia), memory problems; or
  • redness, burning, stinging, or pain where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lupron Pediatric (Leuprolide Acetate Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lupron Pediatric FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most common adverse reactions with GnRH agonists including LUPRON DEPOT-PED are injection site reactions/pain including abscess, general pain, headache, emotional lability and hot flushes/sweating.

During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the natural initial stimulatory effect of the drug (hormonal flare effect). Therefore, an increase in clinical signs and symptoms may be observed [see WARNINGS AND PRECAUTIONS].

LUPRON DEPOT-PED-1 Month (7.5 mg, 11.25 mg, and 15 mg Injection) - Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In two studies of children with central precocious puberty, in 2% or more of the patients receiving the drug, the following adverse reactions were reported to have a possible or probable relationship to drug as ascribed by the treating physician. Reactions which are not considered drug-related are excluded.

Table 2: Percentage of Patients with Treatment-Emergent Adverse Reactions Occurring in ≥ 2% of Pediatric Patients Receiving LUPRON DEPOT-PED-1 Month

  Number of Patients (N = 421)
N (%)
Body as a Whole
  Injection Site Reactions Including Abscess* 37 (9)
  General Pain 12 (3)
  Headache 11 (3)
Cardiovascular System
  Vasodilation 9 (2)
Integumentary System (Skin and Appendages)
  Acne/Seborrhea 13 (3)
  Rash Including Erythema Multiforme 12 (3)
Nervous System
  Emotional Lability 19 (5)
Urogenital System
  Vaginitis/Vaginal Bleeding/Vaginal Discharge 13 (3)
*Most events were mild or moderate in severity.

Less Common Adverse Reactions

The following treatment-emergent adverse reactions were reported in less than 2% of the patients and are listed below by body system.

Body as a Whole - aggravation of preexisting tumor and decreased vision, allergic reaction, body odor, fever, flu syndrome, hypertrophy, infection; Cardiovascular System - bradycardia, hypertension, peripheral vascular disorder, syncope; Digestive System - constipation, dyspepsia, dysphagia, gingivitis, increased appetite, nausea/vomiting; Endocrine System - accelerated sexual maturity, feminization, goiter; Hemic and Lymphatic System - purpura; Metabolic and Nutritional Disorders - growth retarded, peripheral edema, weight gain; Musculoskeletal System - arthralgia, joint disorder, myalgia, myopathy; Nervous System - depression, hyperkinesia, nervousness, somnolence; Respiratory System - asthma, epistaxis, pharyngitis, rhinitis, sinusitis; Integumentary System (Skin and Appendages) - alopecia, hair disorder, hirsutism, leukoderma, nail disorder, skin hypertrophy; Urogenital System - cervix disorder/neoplasm, dysmenorrhea, gynecomastia/breast disorders, menstrual disorder, urinary incontinence.

Laboratory: The following laboratory events were reported as adverse reactions: antinuclear antibody present and increased sedimentation rate.

Postmarketing

The following adverse events have been observed with this or other formulations of leuprolide acetate injection. As leuprolide has multiple indications, and therefore patient populations, some of these adverse events may not be applicable to every patient.

Allergic reactions (anaphylactic, rash, urticaria, and photosensitivity reactions) have also been reported.

Gastrointestinal Disorders: nausea, abdominal pain, vomiting;

General Disorders and Administration Site Conditions: chest pain, injection site reactions including induration and abscess have been reported;

Investigations: decreased WBC, weight increased;

Metabolism and Nutrition Disorders: diabetes mellitus;

Musculoskeletal and Connective Tissue Disorders: tenosynovitis-like symptoms;

Nervous System Disorders: neuropathy peripheral, convulsion, spinal fracture/paralysis;

Skin and Subcutaneous Tissue Disorders: hot flush, flushing, hyperhidrosis;

Reproductive System and Breast Disorders: prostate pain;

Vascular Disorders: hypertension, hypotension.

Pituitary apoplexy: During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed, with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.

See other LUPRON DEPOT and LUPRON Injection package inserts for other events reported in different patient populations.

Read the entire FDA prescribing information for Lupron Pediatric (Leuprolide Acetate Injection) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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