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Lupron Depot-PED Side Effects

Generic name: leuprolide

Medically reviewed by Drugs.com. Last updated on Jan 1, 2024.

Note: This document contains side effect information about leuprolide. Some dosage forms listed on this page may not apply to the brand name Lupron Depot-PED.

Applies to leuprolide: emulsion, powder for suspension 1 month, powder for suspension 3 month, powder for suspension 4 month, powder for suspension 6 month, solution.

Serious side effects of Lupron Depot-PED

Along with its needed effects, leuprolide (the active ingredient contained in Lupron Depot-PED) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking leuprolide:

For adults

Less common

Rare

For males only (adults)

More common

Rare

Incidence not known

For females only (adults)

Rare

For children

More common

Less common

Rare

Incidence not known

For females only (children)—expected in first few weeks

Rare

Other side effects of Lupron Depot-PED

Some side effects of leuprolide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For adults

More common

Less common

For females only (adults)

More common

Less common

For males only (adults)

More common

Less common

Incidence not known

For children

More common

For Healthcare Professionals

Applies to leuprolide: intramuscular kit, intramuscular powder for injection, intramuscular powder for injection extended release, subcutaneous emulsion, subcutaneous implant, subcutaneous kit, subcutaneous powder for injection extended release, subcutaneous solution.

General

The most commonly reported side effects were hot flashes or sweats, gastrointestinal disorders, hyperhidrosis, edema, emotional lability or depression, respiratory disorder, urinary disorder, nausea or vomiting, injection site reaction, joint disorders, testicular atrophy, asthenia, flu syndrome, headache, skin reaction, fatigue, and pain.[Ref]

Cardiovascular

Very common (10% or more): ECG changes (19%), ischemia (19%), hot flashes or sweats (57%)

Common (1% to 10%): Hypertension, murmur, phlebitis, thrombosis, arrhythmias, angina pectoris, myocardial infarction, vasodilation

Frequency not reported: Cardiovascular collapse, palpitations, tachycardia, bradycardia, varicose vein, atrial fibrillation, deep thrombophlebitis, mitral valve incompetence, tricuspid valve incompetence, irregular heart rate, pallor, prolonged QT interval

Postmarketing reports: Deep vein thrombosis, hypotension, pulmonary embolism, congestive heart failure[Ref]

Dermatologic

Very common (10% or more): Hyperhidrosis (up to 98%), hair loss (18%)

Common (1% to 10%): Alopecia, skin rash, acne, itching, dry skin, ecchymosis, pruritus, photosensitivity, clamminess, night sweats, skin pigmentation, skin reactions, skin/mucous membrane reaction

Frequency not reported: Hair disorder, nail disorder, cellulitis, herpes zoster, melanosis, dermatitis, macropapular rash, actinic keratosis, hirsutism, skin hypertrophy, carcinoma of skin or ear, skin lesions

Postmarketing reports: Photosensitivity reactions[Ref]

Endocrine

Common (1% to 10%): Decreased testicular size

Very rare (less than 0.01%): Pituitary apoplexy (following initial administration in patients with pituitary adenoma)

Frequency not reported: Androgen-like effect, transient increase in serum testosterone concentrations during the first 2 days of therapy, initial flare of symptoms with management of endometriosis or flare phenomenon, feminization, goiter[Ref]

Pituitary apoplexy included sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse.[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (up to 25%), altered bowel function (up to 14%), constipation (up to 14%), diarrhea (up to 14%), gastrointestinal disorders (14%)

Common (1% to 10%): Dyspepsia, gastroenteritis or colitis, dysphagia, flatulence, gastrointestinal (GI) bleeding, peptic ulcer, rectal polyps, duodenal ulcer

Frequency not reported: Dry mouth, eructation, enlarged abdomen, gingivitis, gum hemorrhage, intestinal obstruction, periodontal abscess, rectal disorder, hematochezia, retching, abdominal distention, taste disorders[Ref]

Genitourinary

Very common (10% or more): Vaginal dryness (37%), vaginitis (up to 28%), breast tenderness (14%), erectile dysfunction, urinary disorder (12%)

Common (1% to 10%): Breast changes, breast enlargement, breast pain, breast soreness or tenderness, menstrual disorders, urinary frequency or urgency, hematuria, urinary tract infection, ovarian hyperstimulation, testicular soreness or pain, penile disorder, vaginal hemorrhage, gynecomastia, decrease in testicular size, impotence, testicular atrophy, vulvovaginal dryness, spotting

Frequency not reported: Dysuria, lactation, urinary tract obstruction, balanitis, decreased urine specific gravity, gynecomastia, penis disorders, testis disorders, epididymitis, urinary incontinence, pelvic pain, dysmenorrhea, pollakiuria, bladder spasms, metrorrhagia, vulvovaginitis

Postmarketing reports: Prostate pain[Ref]

Hematologic

Common (1% to 10%): Anemia

Frequency not reported: Decreased red blood cell count (RBC)/hematocrit/hemoglobin, thrombocytopenia, leucopenia, increased platelets, leukopenia, lymphedema, increased WBC, lymphadenopathy, eosinophilia, purpura

Postmarketing reports: Decreased white blood cell count (WBC)[Ref]

Hepatic

Common (1% to 10%): Increased liver enzymes

Frequency not reported: Hepatitis, hepatomegaly, jaundice, increased liver function tests

Postmarketing reports: Hepatic dysfunction, serious liver injury[Ref]

Hypersensitivity

Frequency not reported: Anaphylaxis, hypersensitivity reactions, allergic reaction

Postmarketing reports: Anaphylactic reactions (e.g., rash, pruritus, urticaria, wheezing or interstitial pneumonitis, anaphylactic reactions)[Ref]

Immunologic

Frequency not reported: Flu syndrome[Ref]

Local

Frequency not reported: Erythema, ecchymosis, induration, abscess, swelling, injection site nodule, ulcers, irritation, necrosis at the site of injection, injection site reaction, gait disturbance[Ref]

Metabolic

Very common (10% or more): Weight gain/loss (up to 13%), edema (14%)

Common (1% to 10%): Anorexia

Uncommon (0.1% to 1%): Abnormal lipids

Frequency not reported: Appetite changes

Frequency not reported: Thirst, hyperglycemia, hyperuricemia, dehydration, hyperlipidemia, gout, hyperkalemia, increased bilirubin, insulin resistance

Postmarketing reports: Diabetes[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 12%)

Common (1% to 10%): Bone or joint pain, myalgia, ankylosing spondylosis, arthritis, blurred disc margins, bone fracture, joint disorder, leg cramps, muscle stiffness, muscle weakness or tenderness, pelvic fibrosis, spasms, or cramps

Uncommon (0.1% to 1%): Weakness of lower extremities

Frequency not reported: Backache, muscle atrophy, limb pain, loss of bone mineral density, neck pain, ptosis, rib fracture, bursitis, osteoarthritis, pain in extremity, arthropathy

Postmarketing reports: Joint or muscle pain, spinal fracture or paralysis, tenosynovitis-like symptoms, decreased bone density[Ref]

Nervous system

Very common (10% or more): Headache (sometimes severe [up to 65%]), migraine (up to 65%), asthenia (up to 18%), dizziness/lightheadedness (up to 16%), vertigo (up to 16%)

Common (1% to 10%): Memory disorder, neuromuscular disorder, paresthesia

Frequency not reported: Convulsions, syncope, taste perversion, hypesthesia, tinnitus, abnormal thinking, amnesia, confusion, dementia, cerebrovascular accident/transient ischemic attack, hyperkinesia, ataxia, hypertonia, lethargy

Postmarketing reports: Peripheral neuropathy, stroke, symptoms consistent with fibromyalgia, sudden headache, transient Ischaemic attack[Ref]

Ocular

Frequency not reported: Conjunctivitis, ophthalmologic disorders, visual impairment, amblyopia, dry eyes

Postmarketing reports: Ophthalmoplegia, visual changes[Ref]

Oncologic

Frequency not reported: Neoplasm, cyst, bladder carcinoma, second primary neoplasm, tumor flare[Ref]

Second primary neoplasms include basal cell carcinoma, bladder transitional cell carcinoma, lung neoplasm, malignant melanoma, non-Hodgkin's lymphoma, and squamous cell carcinoma.[Ref]

Other

Very common (10% or more): Pain (up to 24%), general pain (up to 23%)

Common (1% to 10%): Tinnitus, edema peripheral, infection

Frequency not reported: Body odor, disturbance of smell/taste, decreased albumin, fever, decreased prostatic acid phosphatase, decreased total protein, increased BUN, increased phosphorus, increased prostatic acid phosphatase, increased total cholesterol, accidental injury, hernia, abnormal healing, prostate disorder, decreased bicarbonate, decreased HDL-cholesterol, increased glucose, fatigue, induration, increased urea nitrogen, hyperphosphatemia, increased prothrombin time (PT), increased partial thromboplastin time (PTT), decreased potassium, increased ALT, increased LDH, chills, hypothermia, pitting edema, increased calcium, increased alanine amino transferase, increased aspartate aminotransferase, increased gamma-glutamyl transferase (GGT), hard nodule in throat, hypertrophy, present antinuclear antibody, increased sedimentation rate

Postmarketing reports: Hearing disorder[Ref]

Psychiatric

Very common (10% or more): Depression (up to 31%), emotional lability (up to 31%), insomnia/sleep disorder (up to 31%), decreased libido (up to 11%)

Common (1% to 10%): Anxiety, nervousness, mood changes, increased libido, decreased libido

Frequency not reported: Delusions, agitation

Postmarketing reports: Altered mental status, suicidal ideation, suicide attempt, mood swings[Ref]

Renal

Uncommon (0.1% to 1%): Renal calculus, uric aciduria, hematuria, hemorrhagic cystitis, nocturia

Frequency not reported: Hydronephrosis, renal failure[Ref]

Respiratory

Common (1% to 10%): Dyspnea, sinus congestion, chest tightness, decreased breathing sounds, hemoptysis, pleuritic chest pain, pulmonary infiltrate, rales/rhonchi, rhinitis, strep throat, wheezing/bronchitis, pulmonary edema, pulmonary embolism, respiratory disorder, cough, COPD

Frequency not reported: Interstitial lung disease (ILD), emphysema, hemoptysis, lung edema, increased sputum, increased creatinine, epistaxis, pharyngitis, pneumonia, pleural effusion, hypoxia, hiccup, voice alteration, influenza-like illness, pleural rub

Postmarketing reports: Shortness of breath, symptoms consistent with asthmatic process[Ref]

Influenza-like illness include influenza, nasal congestion, nasopharyngitis, rhinorrhea, upper respiratory tract infection, and viral upper respiratory tract infection.[Ref]

Frequently asked questions

References

1. Product Information. Lupron (leuprolide). TAP Pharmaceuticals Inc. 2002;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

4. Product Information. Eligard (leuprolide). sanofi-aventis. 2019.

5. Product Information. Camcevi (leuprolide). Accord Biopharma Inc. 2022.

6. Product Information. Fensolvi (leuprolide). Tolmar Pharmaceuticals. 2022.

7. Product Information. Lupron Depot-Gyn (leuprolide). TAP Pharmaceuticals Inc. 2020.

8. Product Information. Lupron Depot-Ped (leuprolide). AbbVie US LLC. 2022.

9. Product Information. Viadur (leuprolide). Bayer Pharmaceutical Inc. 2006.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.