Pamorelin Adverse Reactions

The majority of adverse effects related to triptorelin results from its pharmacological action, i.e., induced variation in serum testosterone levels, either an increase in testosterone at the initiation of treatment, or a decrease in testosterone once castration is achieved in men. These effects included hot flushes, erectile dysfunction, and decreased libido. Hot flushes, vaginal dryness, and amenorrhea occurred in female patients. Abnormalities in laboratory values (i.e., decreased hemoglobin and red blood cell counts; and increased glucose, blood urea nitrogen, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase levels) also occurred in patients treated with triptorelin.
Infections and infestations: Influenza, urinary tract infection.
Neoplasms benign, malignant and unspecified (including cysts and polyps): Metastatic pain, pathological fracture, pituitary adenoma, (temporary) tumor flare (prostate cancer).
Blood and lymphatic system disorders: Anemia, lymphadenopathy, lymphocytosis, thrombocytosis.
Immune system disorders: Anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, angioedema, angioneurotic edema, hypersensitivity, immuno-allergic reactions, urticaria.
Endocrine disorders: Pituitary apoplexy.
Metabolism and nutrition disorders: Anorexia, decreased appetite, diabetes mellitus, edema, fluid retention, glucose intolerance, gout, hyperglycemia, hyperlipidemia, hyperuricemia, increased appetite, obesity, peripheral edema, weight gain.
Psychiatric disorders: Aggression, altered mental status, anger, anxiety, confusional state, crying, decreased activity, depression, depression aggravated, disorientation, disturbance in attention, emotional/affect lability, emotional distress, euphoric mood, impatience, insomnia, loss of libido, mood changes, mood disorder, nervousness, sleep disorder, somnolence, suicide attempts, suicide ideation.
Nervous system disorders: Amnesia, central nervous system hemorrhage, cerebral ischemia, cerebrovascular accident, convulsions, dizziness, dysstasia, headache, hypoesthesia, loss of consciousness, memory impairment, migraine, neuropathy, paresthesia (especially of lower extremities), paralysis of lower extremities, spinal cord compression, tremor, vertigo.
Eye disorders: Abnormal sensation in the eye, conjunctivitis, dry eye, eye pain, ophthalmoplegia, papilledema, visual blurred, visual changes, visual disturbances, visual impairment.
Ear and labyrinth disorders: Otitis externa, tinnitus.
Cardiac disorders: Chest pain, myocardial infarction, myocardial ischemia, palpitations.
Vascular disorders: Cardiovascular collapse, deep vein thrombosis, embolism, flushing, hypertension, hypotension, syncope, syncope vasovagal, transient ischemic attack, thromboembolic events, thrombophlebitis.
Respiratory, thoracic and mediastinal disorders: Bronchitis, coughing, dyspnea, epistaxis, interstitial lung disease, nasopharyngitis, orthopnea, pharyngitis, pulmonary embolism, rhinitis, sinusitis, upper respiratory tract infection.
Gastrointestinal disorders: Abdominal discomfort, abdominal distension, abdominal pain, anal pruritus, constipation, diarrhea, dry mouth, dysgeusia, dyspepsia, flatulence, gastroenteritis, gastroesophageal reflux, mouth ulceration, nausea, tenesmus, vomiting.
Hepatobiliary disorders: Abnormal hepatic function, cholestatic hepatitis.
Skin and subcutaneous tissue disorders: Acne, alopecia, blister, bullous eruption, bruising, dry skin, eczema, erythema, hirsutism, onychoclasis, photosensitivity reactions, purpura, pruritus, rash, seborrhea, skin disorder.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain, bone fracture, bone loss, bone pain, joint stiffness, joint swelling, leg cramps, leg pain, muscle cramps, muscular weakness (especially of the lower extremities), musculoskeletal disorder, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, osteoporosis, pain in extremity.
Renal and urinary disorders: Bladder outlet obstruction, dysuria, hematuria, nocturia, pollakiuria, renal impairment, renal pain, urethral disorders, urethral obstruction, urinary incontinence, urinary retention.
Reproductive system and breast disorders: Breast disorder, breast pain, coital bleeding, cystocele, dysmenorrhea, dyspareunia, ejaculation disorder, ejaculation failure, genital hemorrhage, gynecomastia, impotence, mastitis, menorrhagia, menstrual disorder, metrorrhagia, orchitis (noninfective), ovarian cyst, ovarian hyperstimulation syndrome, ovarian hypertrophy pelvic pain, pelvic pain, perineal pain, prostate disorder, reduced size of genitalia, testicular atrophy, testicular disorder, testicular pain, uterine hemorrhage, vaginal bleeding, vaginal discharge, vaginal dryness, vulvovaginal dryness, withdrawal bleeding.
General disorders and administration site conditions: Aggravation of postoperative problems, asthenia, dependent edema, fatigue, hyperhidrosis, influenza-like syndrome, injection site bruising, injection site edema, injection site erythema, injection site extravasation (after subcutaneous injection), injection site induration, injection site inflammation, injection site pain, injection site pruritus, injection site reaction, injection site swelling, irritability, lethargy, malaise, pain, pyrexia, rigors.
Investigations: Altered serum testosterone levels, decreased estrogen levels, decreased hemoglobin, decreased red blood cells, decreased weight, increased alanine aminotransferase, increased alkaline phosphatase, increased aspartate aminotransferase, increased blood creatinine, increased blood pressure, increased blood prolactin, increased blood urea, increased blood urea nitrogen, increased blood urea nitrogen (not originating from proteins), increased body temperature, increased plasma estradiol levels, increased estrogen levels, increased fasting glucose, increased gamma-glutamyltransferase, increased glucose, increased lymphocyte count, increased mean testosterone levels, increased plasma estradiol levels, increased prostatic antigen, increased prothrombin time, increased weight, prolonged QT.
Injury, poisoning and procedural complications: Fractures.