Note: This document contains side effect information about triptorelin. Some dosage forms listed on this page may not apply to the brand name Triptodur.
Applies to triptorelin: parenteral powder for injection.
Side effects include:
Men with metastatic prostate cancer (Trelstar®): Hot flushes (flashes), skeletal pain, neuropathy, hematuria, urethral or bladder outlet obstruction, impotence, headache, pain at injection site, leg pain and edema, dysuria, hypertension.
Also observed in adults receiving 11.25-mg formulation (Trelstar®): Decreased hemoglobin concentrations and erythrocyte counts, increased BUN, increased serum concentrations of glucose, AST, ALT, and alkaline phosphatase.
Also observed in adults receiving 22.5-mg formulation (Trelstar®): Decreased hemoglobin concentrations, increased serum glucose and hepatic aminotransferase (transaminase) concentrations.
Pediatric patients ≥2 years of age with precocious puberty (Triptodur®): Injection site reactions, vaginal bleeding, hot flush, headache, cough, infection (i.e., bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, upper respiratory infection).
For Healthcare Professionals
Applies to triptorelin: intramuscular powder for injection, intramuscular powder for injection extended release.
General
The most common adverse events were hot flushes, impotence, decreased libido, skeletal pain, and headache.[Ref]
Cardiovascular
Very common (10% or more): Hot flush (73%), hypertension (14%)
Common (1% to 10%): Dependent edema
Uncommon (0.1% to 1%): Embolism
Rare (less than 0.1%): Hypotension
Postmarketing reports: Blood pressure increased, thromboembolic events including, but not limited to, pulmonary emboli, cerebrovascular accident, myocardial infarction, deep venous thrombosis, transient ischemic attack, and thrombophlebitis[Ref]
Genitourinary
Very common (10% or more): Impotence (40%), urinary tract infection (12%), erectile dysfunction (10%), dysuria; women: dyspareunia, dysmenorrhea, ovarian hyperstimulation syndrome, ovarian hypertrophy, pelvic pain, vulvovaginal dryness, bleeding/spotting, genital hemorrhage (including menorrhagia and metrorrhagia)
Common (1% to 10%): Testicular atrophy, breast pain, gynecomastia, urinary retention, vaginal bleeding (children)
Uncommon (0.1% to 1%): Testicular pain, vaginal discharge (children)
Rare (less than 0.1%): Ejaculation failure
Frequency not reported: Testosterone levels increased, testosterone levels decreased, worsening of urethral or bladder outlet obstruction, worsening of symptoms of endometriosis
Postmarketing reports: Amenorrhea[Ref]
At the beginning of treatment, endometriosis symptoms including pelvic pain and dysmenorrhea are commonly exacerbated due to an initial transient increase in plasma estradiol levels. These symptoms are transient and usually disappear in one to two weeks.[Ref]
Psychiatric
Very common (10% or more): Decreased libido (40%), sleep disorders, mood changes
Common (1% to 10%): Insomnia, emotional lability, loss of libido, depression, depressed mood, irritability
Rare (less than 0.1%): Confusional state, decreased activity, euphoric mood
Postmarketing reports: Anxiety, affect lability, nervousness[Ref]
Hematologic
Very common (10% or more): Decreased hemoglobin, decreased red blood count
Common (1% to 10%): Anemia
Frequency not reported: Increased lymphocyte count[Ref]
Hepatic
Very common (10% or more): Increased AST, increased ALT, increased alkaline phosphatase, increased hepatic transaminases
Common (1% to 10%): Abnormal hepatic function
Uncommon (0.1% to 1%): Gama-glutamyl transferase increased
Rare (less than 0.1%): Blood alkaline phosphatase increased[Ref]
Metabolic
Very common (10% or more): Increased glucose
Common (1% to 10%): Diabetes mellitus/hyperglycemia, anorexia
Uncommon (0.1% to 1%): Weight increased, gout, increased appetite, weight decreased[Ref]
Renal
Very common (10% or more): Increased BUN
Uncommon (0.1% to 1%): Blood creatinine increased
Frequency not reported: Worsening hematuria, decreased kidney function[Ref]
Respiratory
Very common (10% or more): Influenza (16%)
Common (1% to 10%): Bronchitis, coughing, dyspnea, pharyngitis
Uncommon (0.1% to 1%): Asthma aggravated
Rare (less than 0.1%): Orthopnea, epistaxis, nasopharyngitis[Ref]
Musculoskeletal
Very common (10% or more): Skeletal pain (13%), back pain (11%)
Common (1% to 10%): Pain in extremity, arthralgia, edema in legs, leg cramps, myalgia, musculoskeletal pain, muscle spasms
Uncommon (0.1% to 1%): Muscle cramp, muscular weakness
Rare (less than 0.1%): Joint stiffness, joint swelling, musculoskeletal stiffness, osteoarthritis
Frequency not reported: Worsening of bone pain, increased bone loss, osteoporosis, bone fracture, bone disorder, epiphysiolysis, slipped capital femoral epiphysis
Postmarketing reports: Bone pain[Ref]
Nervous system
Very common (10% or more): Paresthesia in lower limbs
Common (1% to 10%): Headache, dizziness, fatigue
Uncommon (0.1% to 1%): Tinnitus, somnolence, paresthesia
Rare (less than 0.1%): Vertigo, dysstasia, memory impairment
Frequency not reported: Worsening of neuropathy, spinal cord compression with weakness or paralysis of the lower extremities
Postmarketing reports: Convulsions[Ref]
Other
Very common (10% or more): Asthenia
Common (1% to 10%): Leg pain, peripheral edema, leg pain, back pain, fatigue, chest pain, edema
Uncommon (0.1% to 1%): Lethargy, pain, rigors, blood lactate dehydrogenase increased, blood cholesterol increased
Rare (less than 0.1%): Pyrexia, influenza like illness, body temperature increased
Frequency not reported: Chills
Postmarketing reports: Malaise[Ref]
Dermatologic
Very common (10% or more): Hyperhidrosis
Common (1% to 10%): Rash, pruritus
Uncommon (0.1% to 1%): Acne, alopecia, hypotrichosis
Rare (less than 0.1%): Purpura, blister
Postmarketing reports: Angioneurotic edema, urticaria[Ref]
Hypersensitivity
Common (1% to 10%): Hypersensitivity reaction
Uncommon (0.1% to 1%): Allergic reactions
Rare (less than 0.1%): Anaphylactic reaction, hypersensitivity
Frequency not reported: Anaphylactic shock, angioedema[Ref]
Local
Common (1% to 10%): Injection site pain, injection site reactions, injection site erythema, injection site inflammation[Ref]
Gastrointestinal
Common (1% to 10%): Nausea, vomiting, constipation, dyspepsia, diarrhea, abdominal pain, abdominal discomfort
Uncommon (0.1% to 1%): Abdominal pain upper, dry mouth
Rare (less than 0.1%): Abdominal distension, dysgeusia, flatulence
Frequency not reported: Gastralgia[Ref]
Ocular
Common (1% to 10%): Eye pain, conjunctivitis
Rare (less than 0.1%): Abnormal sensation in eye, visual disturbance
Postmarketing reports: Vision blurred[Ref]
Oncologic
Frequency not reported: Tumor flare, exacerbation of disease symptoms
Postmarketing reports: Pituitary adenoma[Ref]
Tumor flare occurred in 5% or less of patients, usually manifested by an increase in urinary symptoms and metastatic pain.[Ref]
Endocrine
Postmarketing reports: Pituitary apoplexy[Ref]
The majority of pituitary apoplexy cases occurred within 2 weeks of the first dose, some within the first hour. In these cases, pituitary apoplexy presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.[Ref]
