Summary

More frequently reported side effects include: diabetes mellitus and hyperglycemia. Continue reading for a comprehensive list of adverse effects.

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]