Recommended Topic Related To:

Lupron Depot 3.75

"Treatment approaches for endometriosis often rely on a combination of evidence-based and experience-based (“unsubstantiated” by systematic data and research) approaches. As a result, women with endometriosis may find only temporary or no relief f"...

Lupron Depot 3.75 mg

Lupron Depot 3.75 Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lupron Depot 3.75 Mg (leuprolide acetate) is used in men to treat the symptoms of prostate cancer, and in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids. It is also used to treat precocious (early-onset) puberty in both male and female children. Lupron Dept is a synthetic gonadotropin-releasing hormone. Common side effects include hot flashes (flushing), increased sweating, night sweats, tiredness, headache, upset stomach, breast changes, acne, joint/muscle aches, trouble sleeping, reduced sexual interest, vaginal discomfort/dryness, abnormal vaginal bleeding (in girls), swelling of the ankles/feet, dizziness, or mild burning/pain/bruising at the injection site. When used regularly, it is expected menstrual periods will stop (or decrease), and will usually return within 2 months after treatment is stopped.

Dosage of Lupron Depot depends on the condition being treated, and the patient's age and sex. There may be other drugs that can interact with Lupron Depot. Tell your doctor about all prescription and over-the-counter medications and supplements you use. Lupron Depot must not be used during pregnancy. It may harm a fetus. Non-hormonal birth control methods (e.g., condoms, diaphragm with spermicide) are recommended during treatment. It is not known if this medication passes into breast milk. Because the effects of this drug on a nursing infant are unknown, breast-feeding is not recommended.

Our Lupron Depot (leuprolide acetate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lupron Depot 3.75 in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • bone pain, loss of movement in any part of your body;
  • swelling, rapid weight gain;
  • pain, burning, stinging, bruising, or redness where the medication was injected;
  • feeling like you might pass out;
  • sudden chest pain or discomfort, wheezing, dry cough or hack;
  • painful or difficult urination;
  • urinating more often than usual;
  • high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
  • sudden numbness or weakness (especially on one side of the body), problems with speech or balance;
  • sudden headache with vision problems, vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing; or
  • chest pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Rare but serious side effects may include:

  • pain or unusual sensations in your back;
  • numbness, weakness, or tingly feeling in your legs or feet;
  • muscle weakness or loss of use;
  • loss of bowel or bladder control; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • acne, increased growth of facial hair;
  • breakthrough bleeding in a female child during the first 2 months of leuprolide treatment;
  • dizziness, weakness, tired feeling;
  • hot flashes, night sweats, chills, clammy skin;
  • nausea, diarrhea, constipation, stomach pain;
  • skin redness, itching, or scaling;
  • joint or muscle pain;
  • vaginal itching or discharge;
  • breast swelling or tenderness;
  • testicle pain;
  • impotence, loss of interest in sex;
  • depression, sleep problems (insomnia), memory problems; or
  • redness, burning, stinging, or pain where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lupron Depot 3.75 (Leuprolide Acetate Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Lupron Depot 3.75 Overview - Patient Information: Side Effects

SIDE EFFECTS: Hot flashes (flushing), increased sweating, night sweats, tiredness, headache, upset stomach, breast changes, acne, joint/muscle aches, trouble sleeping, reduced sexual interest, vaginal discomfort/dryness, abnormal vaginal bleeding (in girls), swelling of the ankles/feet, dizziness, or mild burning/pain/bruising at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

When this medication is used regularly, it is expected that the menstrual period will stop (or decrease to light bleeding/spotting). Menstrual periods usually return within 2 months after treatment is stopped. Tell your doctor promptly if regular periods continue during treatment with leuprolide.

During the first few weeks of treatment, your hormone levels will actually increase before they decrease. This is a normal response by your body to this drug. This may result in a temporary worsening of your symptoms for a few weeks.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., new or worsening depression, thoughts of suicide, mood swings, memory problems, aggression in children), bone pain (in adults), easily broken bones (in adults).

Get medical help right away if you have any very serious side effects, including: seizures.

Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first injection. Get medical help right away if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (e.g., severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Lupron Depot 3.75 (Leuprolide Acetate Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lupron Depot 3.75 FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials

Estradiol levels may increase during the first weeks following the initial injection of LUPRON, but then decline to menopausal levels. This transient increase in estradiol can be associated with a temporary worsening of signs and symptoms (see WARNINGS section).

As would be expected with a drug that lowers serum estradiol levels, the most frequently reported adverse reactions were those related to hypoestrogenism.

The monthly formulation of LUPRON DEPOT 3.75 mg was utilized in controlled clinical trials that studied the drug in 166 endometriosis and 166 uterine fibroids patients. Adverse events reported in ≥ 5% of patients in either of these populations and thought to be potentially related to drug are noted in the following table.

Table 2 : ADVERSE EVENTS REPORTED TO BE CAUSALLY RELATED TO DRUG IN ≥ 5% OF PATIENTSS

  Endometriosis (2 Studies) Uterine Fibroids (4 Studies)
LUPRON DEPOT 3.75 mg
N=166
Danazol
N=136
Placebo
N=31
LUPRON DEPOT 3.75 mg
N=166
Placebo
N=163
N (%) N (%) N (%) N (%) N (%)
Body as a Whole
  Asthenia 5 (3) 9 (7) 0 (0) 14 (8.4) 8 (4.9)
  General pain 31 (19) 22 (16) 1 (3) 14 (8.4) 10 (6.1)
  Headache* 53 (32) 30 (22) 2 (6) 43 (25.9) 29 (17.8)
Cardiovascular System
  Hot flashes/sweats* 139 (84) 77 (57) 9 (29) 121 (72.9) 29 (17.8)
Gastrointestinal System
  Nausea/vomiting 21 (13) 17 (13) 1 (3) 8 (4.8) 6 (3.7)
  GI disturbances* 11 (7) 8 (6) 1 (3) 5 (3.0) 2 (1.2)
Metabolic and Nutritional Disorders
  Edema 12 (7) 17 (13) 1 (3) 9 (5.4) 2 (1.2)
  Weight gain/loss 22 (13) 36 (26) 0 (0) 5 (3.0) 2 (1.2)
Endocrine System
  Acne 17 (10) 27 (20) 0 (0) 0 (0) 0 (0)
  Hirsutism 2 (1) 9 (7) 1 (3) 1 (0.6) 0 (0)
Musculoskeletal System
  Joint disorder* 14 (8) 11 (8) 0 (0) 13 (7.8) 5 (3.1)
  Myalgia* 1 (1) 7 (5) 0 (0) 1 (0.6) 0 (0)
Nervous System
  Decreased libido* 19 (11) 6 (4) 0 (0) 3 (1.8) 0 (0)
  Depression/emotional lability* 36 (22) 27 (20) 1 (3) 18 (10.8) 7 (4.3)
  Dizziness 19 (11) 4 (3) 0 (0) 3 (1.8) 6 (3.7)
  Nervousness* 8 (5) 11 (8) 0 (0) 8 (4.8) 1 (0.6)
  Neuromuscular disorders* 11 (7) 17 (13) 0 (0) 3 (1.8) 0 (0)
  Paresthesias 12 (7) 11 (8) 0 (0) 2 (1.2) 1 (0.6)
Skin and Appendages
  Skin reactions 17 (10) 20 (15) 1 (3) 5 (3.0) 2 (1.2)
Urogenital System
  Breast changes/tenderness/pain* 10 (6) 12 (9) 0 (0) 3 (1.8) 7 (4.3)
  Vaginitis* 46 (28) 23 (17) 0 (0) 19 (11.4) 3 (1.8)
In these same studies, symptoms reported in < 5% of patients included: Body as a Whole - Body odor, Flu syndrome, Injection site reactions; Cardiovascular System - Palpitations, Syncope, Tachycardia; Digestive System - Appetite changes, Dry mouth, Thirst; Endocrine System - Androgen-like effects; Hemic and Lymphatic System - Ecchymosis, Lymphadenopathy; Nervous System – Anxiety*, Insomnia/Sleep disorders*, Delusions, Memory disorder, Personality disorder; Respiratory System - Rhinitis; Skin and Appendages - Alopecia, Hair disorder, Nail disorder; Special Senses - Conjunctivitis, Ophthalmologic disorders*, Taste perversion; Urogenital System - Dysuria*, Lactation, Menstrual disorders.
* = Possible effect of decreased estrogen.

In one controlled clinical trial utilizing the monthly formulation of LUPRON DEPOT, patients diagnosed with uterine fibroids received a higher dose (7.5 mg) of LUPRON DEPOT. Events seen with this dose that were thought to be potentially related to drug and were not seen at the lower dose included glossitis, hypesthesia, lactation, pyelonephritis, and urinary disorders. Generally, a higher incidence of hypoestrogenic effects was observed at the higher dose.

Table 3 lists the potentially drug-related adverse events observed in at least 5% of patients in any treatment group during the first 6 months of treatment in the add-back clinical studies.

In the controlled clinical trial, 50 of 51 (98%) patients in the LD group and 48 of 55 (87%) patients in the LD/N group reported experiencing hot flashes on one or more occasions during treatment. During Month 6 of treatment, 32 of 37 (86%) patients in the LD group and 22 of 38 (58%) patients in the LD/N group reported having experienced hot flashes. The mean number of days on which hot flashes were reported during this month of treatment was 19 and 7 in the LD and LD/N treatment groups, respectively. The mean maximum number of hot flashes in a day during this month of treatment was 5.8 and 1.9 in the LD and LD/N treatment groups, respectively.

Table 3 : TREATMENT-RELATED ADVERSE EVENTS OCCURRING IN ≥ 5% OF PATIENTS

Adverse Events Controlled Study Open Label Study
LD- Only*
N=51
LD/N†
N=55
LD/N†
N=136
N (%) N (%) N (%)
Any Adverse Event 50 (98) 53 (96) 126 (93)
Body as a Whole
  Asthenia 9 (18) 10 (18) 15 (11)
  Headache/Migraine 33 (65) 28 (51) 63 (46)
  Injection Site Reaction 1 (2) 5 (9) 4 (3)
  Pain 12 (24) 16 (29) 29 (21)
Cardiovascular System
  Hot flashes/sweats 50 (98) 48 (87) 78 (57)
Digestive System
  Altered Bowel Function 7 (14) 8 (15) 14 (10)
  Changes in Appetite 2 (4) 0 (0) 8 (6)
  GI Disturbance 2 (4) 4 (7) 6 (4)
  Nausea/Vomiting 13 (25) 16 (29) 17 (13)
Metabolic and Nutritional Disorders
  Edema 0 (0) 5 (9) 9 (7)
  Weight Changes 6 (12) 7 (13) 6 (4)
Nervous System
  Anxiety 3 (6) 0 (0) 11 (8)
  Depression/Emotional Lability 16 (31) 15 (27) 46 (34)
  Dizziness/Vertigo 8 (16) 6 (11) 10 (7)
  Insomnia/Sleep Disorder 16 (31) 7 (13) 20 (15)
  Libido Changes 5 (10) 2 (4) 10 (7)
  Memory Disorder 3 (6) 1 (2) 6 (4)
  Nervousness 4 (8) 2 (4) 15 (11)
  Neuromuscular Disorder 1 (2) 5 (9) 4 (3)
Skin and Appendages
  Alopecia 0 (0) 5 (9) 4 (3)
  Androgen-Like Effects 2 (4) 3 (5) 24 (18)
  Skin/Mucous Membrane Reaction 2 (4) 5 (9) 15 (11)
Urogenital System
  Breast Changes/Pain/Tenderness 3 (6) 7 (13) 11 (8)
  Menstrual Disorders 1 (2) 0 (0) 7 (5)
  Vaginitis 10 (20) 8 (15) 11 (8)
* LD-Only = LUPRON DEPOT 3.75 mg
† LD/N = LUPRON DEPOT 3.75 mg plus norethindrone acetate 5 mg

Changes in Bone Density

In controlled clinical studies, patients with endometriosis (six months of therapy) or uterine fibroids (three months of therapy) were treated with LUPRON DEPOT 3.75 mg. In endometriosis patients, vertebral bone density as measured by dual energy x-ray absorptiometry (DEXA) decreased by an average of 3.2% at six months compared with the pretreatment value. Clinical studies demonstrate that concurrent hormonal therapy (norethindrone acetate 5 mg daily) and calcium supplementation is effective in significantly reducing the loss of bone mineral density that occurs with LUPRON treatment, without compromising the efficacy of LUPRON in relieving symptoms of endometriosis.

LUPRON DEPOT 3.75 mg plus norethindrone acetate 5 mg daily was evaluated in two clinical trials. The results from this regimen were similar in both studies. LUPRON DEPOT 3.75 mg was used as a control group in one study. The bone mineral density data of the lumbar spine from these two studies are presented in Table 4.

Table 4 : MEAN PERCENT CHANGE FROM BASELINE IN BONE MINERAL DENSITY OF LUMBAR SPINE

  LUPRON DEPOT 3.75mg LUPRON DEPOT 3.75 mg plus norethindrone acetate 5 mg daily
N Controlled Study Change (Mean, 95% CI)# N Controlled Study Change (Mean, 95% CI)# N Open Label Study Change (Mean, 95% CI)#
Week 24* 41 -3.2%
(-3.8, -2.6)
42 -0.3%
(-0.8, 0.3)
115 -0.2%
(-0.6, 0.2)
Week 52 29 -6.3%
(-7.1, -5.4)
32 -1.0%
(-1.9, -0.1)
84 -1.1%
(-1.6, -0.5)
* Includes on-treatment measurements that fell within 2-252 days after the first day of treatment.
† Includes on-treatment measurements > 252 days after the first day of treatment.
# 95% CI: 95% Confidence Interval

When LUPRON DEPOT 3.75 mg was administered for three months in uterine fibroid patients, vertebral trabecular bone mineral density as assessed by quantitative digital radiography (QDR) revealed a mean decrease of 2.7% compared with baseline. Six months after discontinuation of therapy, a trend toward recovery was observed. Use of LUPRON DEPOT for longer than three months (uterine fibroids) or six months (endometriosis) or in the presence of other known risk factors for decreased bone mineral content may cause additional bone loss and is not recommended.

Changes in Laboratory Values During Treatment

Plasma Enzymes

Endometriosis

During early clinical trials with LUPRON DEPOT 3.75 mg, regular laboratory monitoring revealed that AST levels were more than twice the upper limit of normal in only one patient. There was no clinical or other laboratory evidence of abnormal liver function.

In two other clinical trials, 6 of 191 patients receiving LUPRON DEPOT 3.75 mg plus norethindrone acetate 5 mg daily for up to 12 months developed an elevated (at least twice the upper limit of normal) SGPT or GGT. Five of the 6 increases were observed beyond 6 months of treatment. None were associated with elevated bilirubin concentration.

Uterine Leiomyomata (Fibroids)

In clinical trials with LUPRON DEPOT 3.75 mg, five (3%) patients had a post-treatment transaminase value that was at least twice the baseline value and above the upper limit of the normal range. None of the laboratory increases were associated with clinical symptoms.

Lipids

Endometriosis

In earlier clinical studies, 4% of the LUPRON DEPOT 3.75 mg patients and 1% of the danazol patients had total cholesterol values above the normal range at enrollment. These patients also had cholesterol values above the normal range at the end of treatment.

Of those patients whose pretreatment cholesterol values were in the normal range, 7% of the LUPRON DEPOT 3.75 mg patients and 9% of the danazol patients had post-treatment values above the normal range.

The mean (±SEM) pretreatment values for total cholesterol from all patients were 178.8 (2.9) mg/dL in the LUPRON DEPOT 3.75 mg groups and 175.3 (3.0) mg/dL in the danazol group. At the end of treatment, the mean values for total cholesterol from all patients were 193.3 mg/dL in the LUPRON DEPOT 3.75 mg group and 194.4 mg/dL in the danazol group. These increases from the pretreatment values were statistically significant (p < 0.03) in both groups.

Triglycerides were increased above the upper limit of normal in 12% of the patients who received LUPRON DEPOT 3.75 mg and in 6% of the patients who received danazol.

At the end of treatment, HDL cholesterol fractions decreased below the lower limit of the normal range in 2% of the LUPRON DEPOT 3.75 mg patients compared with 54% of those receiving danazol. LDL cholesterol fractions increased above the upper limit of the normal range in 6% of the patients receiving LUPRON DEPOT 3.75 mg compared with 23% of those receiving danazol. There was no increase in the LDL/HDL ratio in patients receiving LUPRON DEPOT 3.75 mg but there was approximately a two-fold increase in the LDL/HDL ratio in patients receiving danazol.

In two other clinical trials, LUPRON DEPOT 3.75 mg plus norethindrone acetate 5 mg daily was evaluated for 12 months of treatment. LUPRON DEPOT 3.75 mg was used as a control group in one study. Percent changes from baseline for serum lipids and percentages of patients with serum lipid values outside of the normal range in the two studies are summarized in the tables below.

Table 5 : SERUM LIPIDS: MEAN PERCENT CHANGES FROM BASELINE VALUES AT TREATMENT WEEK 24

  LUPRON LUPRON plus norethindrone acetate 5 mg daily
Controlled Study (n=39) Controlled Study (n=41) Controlled Study (n=39)
Baseline Value* Wk 24 % Change Baseline Value* Wk 24 % Change Baseline Value* Wk 24 % Change
Total Cholesterol 170.5 9.2% 179.3 0.2% 181.2 2.8%
HDL Cholesterol 52.4 7.4% 51.8 -18.8% 51.0 -14.6%
LDL Cholesterol 96.6 10.9% 101.5 14.1% 109.1 13.1%
LDL/HDL Ratio 2.0f 5.0% 2.1† 43.4% 2.3† 39.4%
Triglycerides 107.8 17.5% 130.2 9.5% 105.4 13.8%
* mg/dL
† ratio

Changes from baseline tended to be greater at Week 52. After treatment, mean serum lipid levels from patients with follow up data returned to pretreatment values.

Table 6 : PERCENTAGE OF PATIENTS WITH SERUM LIPID VALUES OUTSIDE OF THE NORMAL RANGE

  LUPRON LUPRON plus norethindrone acetate 5 mg daily
Controlled Study (n=39) Controlled Study (n=41) Open Label Study (n=117)
Wk 0 Wk 24* Wk 0 Wk 24* Wk 0 Wk 24*
Total Cholesterol (>240 mg/dL) HDL Cholesterol (<40 mg/dL) 15% 15% 23% 10% 15% 15% 20% 44% 6% 15% 7% 41%
LDL Cholesterol (>160 mg/dL) 0% 8% 5% 7% 9% 11%
LDL/HDL Ratio (>4.0) 0% 3% 2% 15% 7% 21%
Triglycerides (>200 mg/dL) 13% 13% 12% 10% 5% 9%
* Includes all patients regardless of baseline value.

Low HDL-cholesterol ( < 40 mg/dL) and elevated LDL-cholesterol ( > 160 mg/dL) are recognized risk factors for cardiovascular disease. The long-term significance of the observed treatment-related changes in serum lipids in women with endometriosis is unknown. Therefore assessment of cardiovascular risk factors should be considered prior to initiation of concurrent treatment with LUPRON and norethindrone acetate.

Uterine Leiomyomata (Fibroids)

In patients receiving LUPRON DEPOT 3.75 mg, mean changes in cholesterol (+11 mg/dL to +29 mg/dL), LDL cholesterol (+8 mg/dL to +22 mg/dL), HDL cholesterol (0 to +6 mg/dL), and the LDL/HDL ratio (-0.1 to +0.5) were observed across studies. In the one study in which triglycerides were determined, the mean increase from baseline was 32 mg/dL.

Other Changes

Endometriosis

The following changes were seen in approximately 5% to 8% of patients. In the earlier comparative studies, LUPRON DEPOT 3.75 mg was associated with elevations of LDH and phosphorus, and decreases in WBC counts. Danazol therapy was associated with increases in hematocrit, platelet count, and LDH. In the hormonal add-back studies LUPRON DEPOT in combination with norethindrone acetate was associated with elevations of GGT and SGPT.

Uterine Leiomyomata (Fibroids)

Hematology: (see Clinical Studies section) In LUPRON DEPOT 3.75 mg treated patients, although there were statistically significant mean decreases in platelet counts from baseline to final visit, the last mean platelet counts were within the normal range. Decreases in total WBC count and neutrophils were observed, but were not clinically significant.

Chemistry: Slight to moderate mean increases were noted for glucose, uric acid, BUN, creatinine, total protein, albumin, bilirubin, alkaline phosphatase, LDH, calcium, and phosphorus. None of these increases were clinically significant.

Postmarketing

The following adverse reactions have been identified during postapproval use of LUPRON DEPOT. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

During postmarketing surveillance, the following adverse events were reported. Like other drugs in this class, mood swings, including depression, have been reported. There have been rare reports of suicidal ideation and attempt. Many, but not all, of these patients had a history of depression or other psychiatric illness. Patients should be counseled on the possibility of development or worsening of depression during treatment with LUPRON.

Symptoms consistent with an anaphylactoid or asthmatic process have been rarely reported. Rash, urticaria, and photosensitivity reactions have also been reported.

Localized reactions including induration and abscess have been reported at the site of injection. Symptoms consistent with fibromyalgia (eg: joint and muscle pain, headaches, sleep disorder, gastrointestinal distress, and shortness of breath) have been reported individually and collectively.

Other events reported are:

Hepato-biliary disorder: Rarely reported serious liver injury

Injury, poisoning and procedural complications: Spinal fracture

Investigations: Decreased WBC

Musculoskeletal and Connective tissue disorder: Tenosynovitis-like symptoms

Nervous System Disorder: Convulsion, peripheral neuropathy, paralysis

Vascular Disorder: Hypotension

Cases of serious venous and arterial thromboembolism have been reported, including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, and transient ischemic attack. Although a temporal relationship was reported in some cases, most cases were confounded by risk factors or concomitant medication use. It is unknown if there is a causal association between the use of GnRH analogs and these events.

Pituitary apoplexy

During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed, with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.

See other LUPRON DEPOT and LUPRON Injection package inserts for other events reported in different patient populations.

Read the entire FDA prescribing information for Lupron Depot 3.75 (Leuprolide Acetate Injection) »

A A A

Lupron Depot 3.75 mg - User Reviews

Lupron Depot 3.75 mg User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Lupron Depot 3.75 mg sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.


NIH talks about Ebola on WebMD