The majority of adverse reactions related to Triptorelin (Pamorelin) are a result of 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; in women, hot flushes, vaginal dryness and amenorrhea.
Allergic reactions may occur (see Precautions).
Local reactions such as injection site erythema, inflammation or pain were commonly reported.
Hypertension was uncommon. Purpura and hypotension were rare. Thromboembolic events (including pulmonary emboli, cerebrovascular accident, myocardial infarction, deep venous thrombosis, transient ischemic attack and thrombophlebitis) have been reported during post-marketing experience. QT/QTc prolongation has been reported in patients receiving androgen deprivation therapy (see Precautions).
Nervous System Effects:
Paresthesia in the lower limbs was very common. Dizziness and headache were common. Memory impairment, depression, insomnia, irritability, mood swings, confusional state, decreased activity, euphoric mood, anxiety, and emotional lability were also reported.
Edema (peripheral, leg or ankle) was common. Anorexia, gout and increased appetite were uncommon. Increased alkaline phosphatase, diabetes mellitus and hyperglycemia may occur (see Precautions).
Gastrointestinal and Hepatic Effects:
Nausea was commonly reported. Abdominal pain, constipation, diarrhea, and vomiting were uncommon. Abdominal distension, dry mouth, dysgeusia, and flatulence were rare. Dyspepsia and abnormal hepatic function may occur.
Musculoskeletal System Effects:
Back pain was very common. Musculoskeletal pain and pain in the extremity are common. Arthralgia, muscle cramp, muscular weakness, and myalgia were uncommon. Joint stiffness or swelling, musculoskeletal stiffness, osteoarthritis, bone pain, generalized pain, leg or extremity pain, and chest pain may occur.
Nasopharyngitis was rare. Dyspnea was uncommon. Orthopnea and epistaxis were rare. Coughing and bronchitis may occur.
Hyperhidrosis was very common. Seborrhea, acne, alopecia, pruritus, and rash were uncommon. Blister, angioneurotic edema and urticaria have been reported.
Erectile dysfunction and decreased libido were common. Testicular atrophy, gynecomastia and testicular pain were uncommon. Ejaculation failure has been rarely reported. Hot flushes, breast pain, impotence, urinary tract infection, dysuria, and urinary retention may occur. Dyspareunia, dysmenorrhea, genital hemorrhage (including menorrhagia, metrorrhagia), ovarian hyperstimulation syndrome, ovarian hypertrophy, pelvic pain, vulvovaginal dryness, and amenorrhea were very common in women.
Tinnitus was uncommon. Vertigo, abnormal sensation in the eye, visual disturbance, and blurred vision were rare. Eye pain and conjunctivitis may occur.
Asthenia was very common. Fatigue and bruising were commonly reported. Lethargy, pain, rigors, and somnolence were uncommon. Dysstasia, influenza-like illness, pyrexia, malaise, and anemia have also been reported.