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.

Applies to leuprolide: im injectable suspension, sub-q injectable suspension, sub-q injection.

Side effects include:

Men with metastatic prostate cancer (leuprolide (the active ingredient contained in Lupron Depot) acetate injection): Hot flushes (flashes), impotence, decreased libido, testicular atrophy, general pain, ECG changes/ischemia, peripheral edema, asthenia.

Men with metastatic prostate cancer (leuprolide acetate suspension [Lupron Depot^®]): Hot flushes, impotence, decreased libido, testicular atrophy, general pain, GI disorders, edema, injection site reaction, urinary disorder, respiratory disorder, infection, joint disorder, peripheral edema, asthenia, fatigue/lethargy.

Men with metastatic prostate cancer (leuprolide acetate injectable suspension [Eligard^®]): Injection site reactions (transient burning/stinging), hot flushes, malaise and fatigue, testicular atrophy.

Women with endometriosis: Hot flushes, amenorrhea, hypercholesterolemia, depression/emotional lability, dizziness, insomnia/sleep disorder, libido changes (e.g., decreased libido), asthenia, general pain, headache, nausea/vomiting, altered bowel function, weight gain/loss, acne, skin reactions, joint disorder, vaginitis.

Women with uterine leiomyomata: Hot flushes, amenorrhea, depression/emotional lability, asthenia, general pain, headache, joint disorder, vaginitis.

Children with precocious puberty: Injection site reaction (e.g., abscess), emotional lability, general pain, acne/seborrhea, headache, rash (e.g., erythema multiforme), vaginitis/bleeding/discharge, vasodilation.

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, hyperhidrosis, emotional lability/depression, nausea/vomiting, and pain.^[Ref]

Cardiovascular

Very common (10% or more): ECG changes (19%), ischemia (19%), hot flush

Common (1% to 10%): Edema, hypertension, murmur, phlebitis, thrombosis, arrhythmias, angina, myocardial infarction

Frequency not reported: Cardiovascular collapse, palpitations, tachycardia

Postmarketing reports: Deep vein thrombosis, hypotension, pulmonary embolism^[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^[Ref]

Endocrine

Very common (10% or more): Hot flashes (up to 98%)

Very rare (less than 0.01%): Pituitary apoplexy

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/'flare' phenomenon^[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%)

Common (1% to 10%): dyspepsia, gastroenteritis/colitis, dysphagia, flatulence, gastrointestinal (GI) bleeding, GI disturbance, peptic ulcer, rectal polyps

Frequency not reported: Dry mouth, GI distress^[Ref]

Genitourinary

Very common (10% or more): Vaginal dryness (37%), vaginitis (up to 28%), breast tenderness (14%), libido decreased, erectile dysfunction, testicular atrophy

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

Frequency not reported: Dysuria, lactation, urinary tract obstruction^[Ref]

Hematologic

Common (1% to 10%): Anemia

Frequency not reported: Decreased red blood cell count (RBC)/hematocrit/hemoglobin, thrombocytopenia, leucopenia

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

Hepatic

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

Frequency not reported: Hepatitis, hepatomegaly, jaundice

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

Hypersensitivity

Frequency not reported: Anaphylaxis, hypersensitivity reactions

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, pain, swelling, nodules, ulcers, irritation, necrosis at the site of injection^[Ref]

Metabolic

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

Common (1% to 10%): Anorexia

Frequency not reported: Appetite changes

Frequency not reported: Thirst

Postmarketing reports: Diabetes^[Ref]

Musculoskeletal

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

Uncommon (0.1% to 1%): Myalgia, weakness of lower extremities

Frequency not reported: Backache, muscle atrophy, limb pain, loss of bone mineral density

Postmarketing reports: Joint/muscle pain, spinal fracture/paralysis, tenosynovitis-like symptoms^[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

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

Frequency not reported: Convulsions, syncope, taste perversion

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

Ocular

Frequency not reported: Conjunctivitis, ophthalmologic disorders, visual impairment

Postmarketing reports: Ophthalmoplegia, visual changes^[Ref]

Other

Very common (10% or more): Pain (up to 24%), general pain (up to 19%)

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

Frequency not reported: Body odor, disturbance of smell/taste

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

Frequency not reported: Delusions

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

Renal

Uncommon (0.1% to 1%): Renal calculus^[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

Frequency not reported: Interstitial lung disease (ILD)

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