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

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 Fensolvi) 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 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]