FDA label a3901495-3be8-4905-a23f-546685575e8c

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID: 5ef94471-ac43-4aa2-b790-e205bd0d2bf2
SPL ID: a3901495-3be8-4905-a23f-546685575e8c
Version: 4
Effective date: 2006-05-31
Source export date: 2026-10-12
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:50:17

Harmonized identifier links#

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Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		a3901495-3be8-4905-a23f-546685575e8c	id
spl set id		5ef94471-ac43-4aa2-b790-e205bd0d2bf2	set_id

Warnings cross-check#

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warnings

WARNINGS Isolated cases of worsening of signs and symptoms during the first weeks of treatment have been reported. Worsening of symptoms may contribute to paralysis with or without fatal complications.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS In the majority of patients, testosterone levels increased above baseline during the first week, declining thereafter to baseline levels or below by the end of the second week of treatment. This transient increase was occasionally associated with a temporary worsening of signs and symptoms, usually manifested by an increase in bone pain (See " WARNINGS " section). In a few cases, a temporary worsening of existing hematuria and urinary tract obstruction occurred during the first week. Temporary weakness and paresthesia of the lower limbs have been reported in a few cases. Potential exacerbations of signs and symptoms during the first few weeks of treatment is a concern in patients with vertebral metastases and/or urinary obstruction which, if aggravated, may lead to neurological problems or increase the obstruction. In a comparative trial of Leuprolide Acetate Injection versus DES, in 5% or more of the patients receiving either drug, the following adverse reactions were reported to have a possible or probable relationship to drug as ascribed by the treating physician. Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions considered not drug related are excluded. Leuprolide Acetate (N=98) DES (N=101) Number of Reports Cardiovascular System Congestive heart failure 1 5 ECG changes/ischemia 19 22 High blood pressure 8 5 Murmur 3 8 Peripheral edema 12 30 Phlebitis/thrombosis 2 10 Gastrointestinal System Anorexia 6 5 Constipation 7 9 Nausea/vomiting 5 17 Endocrine System Physiologic effect of decreased testosterone Decreased testicular size 7 11 Gynecomastia/breast tenderness or pain 7 63 Hot flashes 55 12 Impotence 4 12 Hemic and Lymphatic System Anemia 5 5 Musculoskeletal System Bone pain 5 2 Myalgia 3 9 Central/Peripheral Nervous System Dizziness/lightheadedness 5 7 General pain 13 13 Headache 7 4 Insomnia/sleep disorders 7 5 Respiratory System Dyspnea 2 8 Sinus congestion 5 6 Integumentary System Dermatitis 5 8 Urogenital System Frequency/urgency 6 8 Hematuria 6 4 Urinary tract infection 3 7 Miscellaneous Asthenia 10 10 In this same study, the following adverse reactions were reported in less than 5% of the patients on leuprolide acetate. Cardiovascular System --Angina, Cardiac arrhythmias, Myocardial infarction, Pulmonary emboli; Gastrointestinal System-- Diarrhea, Dysphagia, Gastrointestinal bleeding, Gastrointestinal disturbance, Peptic ulcer, Rectal polyps; Endocrine System --Libido decrease, Thyroid enlargement; Musculoskeletal System --Joint pain; Central/Peripheral Nervous System --Anxiety, Blurred vision, Lethargy, Memory disorder, Mood swings, Nervousness, Numbness, Paresthesia, Peripheral neuropathy, Syncope/blackouts, Taste disorders; Respiratory System --Cough, Pleural rub, Pneumonia, Pulmonary fibrosis; Integumentary System --Carcinoma of skin/ear, Dry skin, Ecchymosis, Hair loss, Itching, Local skin reactions, Pigmentation, Skin lesions; Urogenital System --Bladder spasms, Dysuria, Incontinence, Testicular pain, Urinary obstruction; Miscellaneous --Depression, Diabetes, Fatigue, Fever/chills, Hypoglycemia, Increased BUN, Increased calcium, Increased creatinine, Infection/inflammation, Ophthalmologic disorders, Swelling (temporal bone). The following additional adverse reactions have been reported with leuprolide acetate during other clinical trials and/or during postmarketing surveillance. Reactions considered as nondrug related by the treating physician are excluded. Cardiovascular System --Hypotension, Transient ischemic attack/stroke; Gastrointestinal System-- Hepatic dysfunction; Endocrine System --Libido increase; Hemic and Lymphatic System --Decreased WBC, Hemoptysis; Musculoskeletal System --Ankylosing spondylosis, Pelvic fibrosis; Central/Peripheral Nervous System --Hearing disorder, Peripheral neuropathy, Spinal fracture/paralysis; Respiratory System-- Pulmonary infiltrate, Respiratory disorders; Integumentary System --Hair growth; Urogenital System --Penile swelling, Prostate pain; Miscellaneous --Hypoproteinemia, Hard nodule in throat, Weight gain, Increased uric acid.

adverse reactions table

<table ID="d9cf2cf0-d979-474e-b9b3-e9dd9bab2b44"> <colgroup> <col align="left"/> <col align="center"/> <col align="center"/> </colgroup> <thead styleCode="Lrule Rrule Toprule Botrule"> <tr> <th styleCode="Lrule Rrule Toprule Botrule" align="left"/> <th styleCode="Lrule Rrule Toprule Botrule" align="center">Leuprolide Acetate (N=98)</th> <th styleCode="Lrule Rrule Toprule Botrule" align="center">DES (N=101)</th> </tr> <tr> <th styleCode="Lrule Rrule Toprule Botrule" align="left"/> <th styleCode="Lrule Rrule Toprule Botrule" colspan="2" align="center">Number of Reports</th> </tr> </thead> <tbody> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph>Cardiovascular System</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Congestive heart failure</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>1</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>5</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> ECG changes/ischemia</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>19</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>22</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> High blood pressure</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>8</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>5</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Murmur</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>3</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>8</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Peripheral edema</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>12</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>30</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Phlebitis/thrombosis</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>10</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph>Gastrointestinal System</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Anorexia</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>6</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>5</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Constipation</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>7</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>9</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Nausea/vomiting</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>5</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>17</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph>Endocrine System</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> <footnote ID="fa7bea00-92cb-4cd6-8e61-54229b5a034c"> Physiologic effect of decreased testosterone</footnote>Decreased testicular size</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>7</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>11</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> <footnoteRef IDREF="fa7bea00-92cb-4cd6-8e61-54229b5a034c"/>Gynecomastia/breast tenderness or pain</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>7</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>63</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> <footnoteRef IDREF="fa7bea00-92cb-4cd6-8e61-54229b5a034c"/>Hot flashes</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>55</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>12</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> <footnoteRef IDREF="fa7bea00-92cb-4cd6-8e61-54229b5a034c"/>Impotence</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>4</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>12</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph>Hemic and Lymphatic System</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Anemia</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>5</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>5</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph>Musculoskeletal System</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Bone pain</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>5</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>2</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Myalgia</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>3</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>9</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph>Central/Peripheral Nervous System</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Dizziness/lightheadedness</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>5</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>7</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> General pain</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>13</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>13</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Headache</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>7</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>4</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Insomnia/sleep disorders</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>7</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>5</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph>Respiratory System</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Dyspnea</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>2</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>8</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Sinus congestion</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>5</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>6</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph>Integumentary System</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Dermatitis</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>5</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>8</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph>Urogenital System</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Frequency/urgency</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>6</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>8</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Hematuria</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>6</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>4</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Urinary tract infection</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>3</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>7</paragraph> </td> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph>Miscellaneous</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> <td styleCode="Lrule Rrule Toprule Botrule" align="center"/> </tr> <tr> <td styleCode="Lrule Rrule Toprule Botrule" align="left"> <paragraph> Asthenia</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>10</paragraph> </td> <td styleCode="Lrule Rrule Toprule Botrule" align="center"> <paragraph>10</paragraph> </td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.