Lupron Depot 11.25 mg Side Effects
Generic Name: leuprolide
Note: This page contains information about the side effects of leuprolide. Some of the dosage forms included on this document may not apply to the brand name Lupron Depot 11.25 mg.
Not all side effects for Lupron Depot 11.25 mg may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to leuprolide: kit, powder for solution, powder for suspension, powder for suspension 1 month, powder for suspension 3 month, powder for suspension 4 month, powder for suspension 6 month, solution
In addition to its needed effects, some unwanted effects may be caused by leuprolide (the active ingredient contained in Lupron Depot 11.25 mg). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking leuprolide:For adultsLess common
- Fast or irregular heartbeat
- Bone, muscle, or joint pain
- fast or irregular breathing
- numbness or tingling of the hands or feet
- puffiness or swelling of the eyelids or around the eyes
- shortness of breath
- skin rash, hives, or itching
- sudden, severe decrease in blood pressure and collapse
- tightness in the chest or wheezing
- troubled breathing
- Arm, back, or jaw pain
- bloody or cloudy urine
- blurred vision
- burning while urinating
- chest pain or discomfort
- chest tightness or heaviness
- difficult or labored breathing
- difficult, burning, or painful urination
- difficulty with moving
- frequent urge to urinate
- increased urge to urinate during the night
- muscle pain or stiffness
- pain in the joints
- pale skin
- pounding in the ears
- slow or fast heartbeat
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- waking to urinate at night
- Pain in the groin or legs (especially in the calves of the legs)
- Altered mental status
- cardiovascular collapse
- double vision
- visual changes
- deepening of voice
- increased hair growth
- mental depression
- mood changes
- Body pain
- burning, itching, redness, or swelling at the injection site
- skin rash
- Vaginal bleeding (continuing)
- white vaginal discharge (continuing)
Some of the side effects that can occur with leuprolide may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:For adultsMore common
- Sudden sweating and feelings of warmth (also called hot flashes)
- Bleeding, bruising, burning, itching, pain, redness, or swelling at the injection site
- decreased interest in sexual intercourse
- swelling of the feet or lower legs
- swelling or increased tenderness of the breasts
- trouble with sleeping
- weight gain
- Light, irregular vaginal bleeding
- stopping of menstrual periods
- Burning, dryness, or itching of the vagina
- pelvic pain
- Back pain
- general feeling of discomfort or illness
- loss of appetite
- pain or discomfort at the injection site
- redness of the face, neck, arms, and occasionally, upper chest
- runny nose
- sore throat
- sudden sweating
- trouble sleeping
- unable to sleep
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- Bone pain
- decreased size of the testicles
- inability to have or keep an erection
For Healthcare Professionals
Applies to leuprolide: intramuscular kit, intramuscular powder for injection, intramuscular powder for injection extended release, subcutaneous implant, subcutaneous kit, subcutaneous powder for injection extended release, subcutaneous solution
Endocrine side effects of leuprolide (the active ingredient contained in Lupron Depot 11.25 mg) have included hot flashes (56% to 91%), gynecomastia (7%), breast changes (7%), breast enlargement (7%), breast tenderness (7% to 14%), decrease in testicular size, diabetes, and impotence. In addition, rare cases of pituitary apoplexy have been reported after the use of gonadotropin-releasing hormone agents.
Endocrine side effects occur in the majority of patients treated with leuprolide and are due to drug-induced hypoestrogenism and hypoandrogenism.
Pituitary apoplexy is a clinical syndrome secondary to infarction of the pituitary gland. In a majority of the cases reported, a pituitary adenoma was diagnosed. A majority of pituitary apoplexy cases occurred within two weeks of the first dose, and some occurred within the first hour. In those cases, pituitary apoplexy presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.
Psychiatric side effects have included depression and emotional lability (up to 45%), insomnia (2% to 7%), anxiety, nervousness, decreased libido (both males and females), increased libido (females), and short-term memory loss.
Nervous system side effects have included headache (7% to 39%), dizziness (5%), blurred vision, lethargy, paresthesias, numbness, peripheral neuropathy, spinal fracture, convulsions, transient ischemic attack, and paralysis. A case of atypical absence seizures induced by leuprolide (the active ingredient contained in Lupron Depot 11.25 mg) acetate has also been reported.
A number of cases of vaginal hemorrhage are reported in the literature. The presence of submucous leiomyomatas may be responsible for these events. These patients typically required emergency surgery and blood transfusions.
Massive ascites developed in one patient 3 weeks after receiving a 3.75 mg leuprolide (the active ingredient contained in Lupron Depot 11.25 mg) depot injection for the treatment of leiomyomata uteri. Upon surgical resection, the uterine myomas were noted to be seeping large amounts of serous fluid.
Genitourinary side effects have included vaginal dryness (37%), urinary frequency, hematuria, ovarian hyperstimulation, testicular soreness/pain, breast soreness/tenderness, testicular atrophy, erectile dysfunction, penile disorder, reduced penis size and vaginal hemorrhage.
Cardiovascular side effects have included ECG changes (19%), ischemia (19%), peripheral edema (12%), hypertension, hypotension, murmur, phlebitis, venous and arterial thromboembolism, deep vein thrombosis, stroke, sudden cardiac death, arrhythmias, angina, pulmonary edema, pulmonary embolism, and myocardial infarction.
Gastrointestinal side effects have included constipation (7%), anorexia (3% to 6%), nausea and vomiting (5%), weight loss, flatulence, dyspepsia, and weight gain.
Dermatologic side effects have included skin rash (7%), acne, dry skin, ecchymosis, hair loss (up to 18% of females), pruritus, photosensitivity, clamminess, night sweats, increased sweating, and skin pigmentation.
An initial increase in testosterone levels may occur during the first 2 weeks of therapy with leuprolide (the active ingredient contained in Lupron Depot 11.25 mg) An increase in bone pain, as well as worsening of other signs and symptoms of advanced prostate cancer, may be noted during this time period.
Hypoestrogenism induced by leuprolide may result in small losses in bone density. Prolonged use of leuprolide in females may increase the risk of osteoporosis.
Musculoskeletal side effects have included increased bone pain in patients with advanced prostate cancer, myalgias, arthralgias, muscle atrophy, limb pain, lower bone density scores, and tenosynovitis-like symptoms. A case of polymyositis and a case of noninflammatory myopathy have also been reported.
A case of anaphylaxis after a single intramuscular injection of leuprolide (the active ingredient contained in Lupron Depot 11.25 mg) depot is reported in the literature. On two occasions, 24 hours and 6 weeks after injection, the patient required emergency airway management. The patient continued to require regular doses of antihistamines and intermittent epinephrine injections up to 14 weeks after leuprolide administration.
Hypersensitivity reactions have included a rare report of urticaria, shortness of breath, and anaphylaxis with the depot form. Other reports of anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have also been reported in the medical literature.
Hematologic side effects have included anemia, leukopenia, and hemoptysis.
Respiratory side effects have included dyspnea, sinus congestion, cough, pleural rub, and pulmonary fibrosis. Postmarketing reports have included interstitial lung disease.
Local side effects have included erythema, ecchymosis, induration, abscess, and irritation at the site of injection.
Oncologic side effects have been reported including case reports of granulomas. Animal studies including an increase in benign pituitary hyperplasia and benign pituitary adenomas, an increase of pancreatic islet cell adenomas in females, and an increase of testicular cell adenomas in males have also been reported.
Other side effects including symptoms consistent with fibromyalgia (e.g., joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported. Hearing disorder, hard nodule in throat, weight gain, and increased uric acid have also been reported.
Hepatic side effects including hepatic dysfunction have been reported. Postmarketing reports of serious drug induced liver injury have been received.
General side effects including sweating, syncope, rigors, weakness, and lethargy have been reported.
Renal side effects have included difficulties with urination, pain on urination, scanty urination, bladder spasm, blood in urine, urinary retention, urinary urgency, incontinence, nocturia, and aggravated nocturia.
Metabolic side effects have included hyperglycemia.
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