Common Lupron Side Effects


The most commonly reported Lupron side effects (click to view or check a box to report):

Hot Flush (716)
Headache (382)
Pain (306)
Arthralgia (294)
Nausea (266)
Fatigue (258)
Vaginal Haemorrhage (250)
Abdominal Pain (216)
Dizziness (210)
Insomnia (180)
Pain In Extremity (178)
Asthenia (177)
Injection Site Pain (166)
Weight Increased (155)
Depression (155)
Death (145)
Menorrhagia (144)
Back Pain (142)
Migraine (135)
Vomiting (135)

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If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Lupron Side Effects Reported to FDA



Lupron Side Effect Report#9993914
Metastases To Spine
This is a report of a male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: prostate cancer,metastatic neoplasm,prostatic specific antigen increased, who was treated with Lupron Depot (dosage: Latest Injection: 19-dec-2013, start time:
Oct 09, 2013), combined with: NA. and developed a serious reaction and side effect(s): Metastases To Spine after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lupron Depot treatment in male patients, resulting in Metastases To Spine side effect.
Lupron Side Effect Report#9993670
Hepatomegaly, Hysterectomy, Menopausal Symptoms, Traumatic Liver Injury, Endometriosis, Thrombosis, Hot Flush, Arthralgia, Bone Pain
This report suggests a potential Lupron Depot Hepatomegaly side effect(s) that can have serious consequences. A female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: endometriosis,adenomyosis and used Lupron Depot (dosage: NA) starting 201304. After starting Lupron Depot the patient began experiencing various side effects, including: Hepatomegaly, Hysterectomy, Menopausal Symptoms, Traumatic Liver Injury, Endometriosis, Thrombosis, Hot Flush, Arthralgia, Bone PainAdditional drugs used concurrently: NA.The patient was hospitalized. Although Lupron Depot demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatomegaly, may still occur.
Lupron Side Effect Report#9993329
Nausea, Abdominal Distension
This Nausea problem was reported by a consumer or non-health professional from Country Not Specified. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: endometriosis. On
Dec 12, 2013 this consumer started treatment with Lupron Depot (dosage: NA). The following drugs were being taken at the same time:
  • Plaquenil
  • Norethindrone Acetate
When using Lupron Depot, the patient experienced the following unwanted symptoms/side effects: Nausea, Abdominal DistensionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nausea, may become evident only after a product is in use by the general population.
Lupron Side Effect Report#9993269
Vaginal Haemorrhage
This Vaginal Haemorrhage side effect was reported by a physician from Country Not Specified. A female patient (weight:NA) experienced the following symptoms/conditions: uterine leiomyoma.The patient was prescribed Lupron Depot (drug dosage: NA), which was initiated on 201311. Concurrently used drugs: NA..After starting to take Lupron Depot the consumer reported adverse symptoms, such as: Vaginal HaemorrhageThese side effects may potentially be related to Lupron Depot.
Lupron Side Effect Report#9993265
Urinary Incontinence, Pelvic Pain, Vaginal Haemorrhage
This is a report of a 51-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: uterine leiomyoma,mineral supplementation,vitamin supplementation, who was treated with Lupron Depot (dosage: NA, start time: 201311), combined with:
  • Iron
  • Vitamin B12
  • Vitamin C
  • Aleve
and developed a serious reaction and side effect(s): Urinary Incontinence, Pelvic Pain, Vaginal Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lupron Depot treatment in female patients, resulting in Urinary Incontinence side effect.
Lupron Side Effect Report#9993263
Nocturia, Insomnia, Hot Flush
This report suggests a potential Lupron Depot Nocturia side effect(s) that can have serious consequences. A 50-year-old patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: endometriosis and used Lupron Depot (dosage: NA) starting
Jan 29, 2014. After starting Lupron Depot the patient began experiencing various side effects, including: Nocturia, Insomnia, Hot FlushAdditional drugs used concurrently:
  • Multivitamin
  • Vitamin D
  • Pumpkin Seed Oil
  • Alfalfa Leaf
  • Norethindrone
Although Lupron Depot demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Nocturia, may still occur.
Lupron Side Effect Report#9993261
Menstruation Irregular, Chills, Piloerection
This Menstruation Irregular problem was reported by a consumer or non-health professional from Country Not Specified. A 36-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: endometriosis. On
Dec 13, 2013 this consumer started treatment with Lupron Depot (dosage: NA). The following drugs were being taken at the same time: NA. When using Lupron Depot, the patient experienced the following unwanted symptoms/side effects: Menstruation Irregular, Chills, PiloerectionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Menstruation Irregular, may become evident only after a product is in use by the general population.
Lupron Side Effect Report#9993256
Feeling Cold, Hot Flush, Pelvic Pain, Abdominal Pain Lower, Abdominal Discomfort, Abdominal Tenderness, Flatulence, Abdominal Distension
This Feeling Cold side effect was reported by a consumer or non-health professional from Country Not Specified. A 51-year-old female patient (weight:NA) experienced the following symptoms/conditions: off label use,uterine enlargement,hypersensitivity.The patient was prescribed Lupron Depot (drug dosage: NA), which was initiated on
Nov 01, 2013. Concurrently used drugs: NA..After starting to take Lupron Depot the consumer reported adverse symptoms, such as: Feeling Cold, Hot Flush, Pelvic Pain, Abdominal Pain Lower, Abdominal Discomfort, Abdominal Tenderness, Flatulence, Abdominal DistensionThese side effects may potentially be related to Lupron Depot.
Lupron Side Effect Report#9993252
Abdominal Pain Upper, Nausea
This is a report of a 35-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: endometriosis, who was treated with Lupron Depot (dosage: NA, start time: 201212), combined with: NA. and developed a serious reaction and side effect(s): Abdominal Pain Upper, Nausea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lupron Depot treatment in female patients, resulting in Abdominal Pain Upper side effect.
Lupron Side Effect Report#9993249
Hot Flush
This report suggests a potential Lupron Depot Hot Flush side effect(s) that can have serious consequences. A 43-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: uterine leiomyoma,mineral supplementation,hypertension and used Lupron Depot (dosage: NA) starting
Jan 21, 2014. After starting Lupron Depot the patient began experiencing various side effects, including: Hot FlushAdditional drugs used concurrently:
  • Corvite
  • Lisinopril
Although Lupron Depot demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hot Flush, may still occur.
Lupron Side Effect Report#9993247
Therapeutic Response Unexpected, Weight Increased, Pain, Arthralgia, Hot Flush, Vaginal Haemorrhage, Painful Defaecation, Abdominal Pain, Vaginal Haemorrhage
This Therapeutic Response Unexpected problem was reported by a consumer or non-health professional from US. A 48-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: endometriosis. On 201311 this consumer started treatment with Lupron Depot (dosage: NA). The following drugs were being taken at the same time:
  • Victoza
  • Fish Oil
  • Vitamin D
  • Asmanex
  • Synthroid
When using Lupron Depot, the patient experienced the following unwanted symptoms/side effects: Therapeutic Response Unexpected, Weight Increased, Pain, Arthralgia, Hot Flush, Vaginal Haemorrhage, Painful Defaecation, Abdominal Pain, Vaginal HaemorrhageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Therapeutic Response Unexpected, may become evident only after a product is in use by the general population.
Lupron Side Effect Report#9993242
Vulvovaginal Mycotic Infection, Pelvic Pain
This Vulvovaginal Mycotic Infection side effect was reported by a consumer or non-health professional from Country Not Specified. A 19-year-old patient (weight:NA) experienced the following symptoms/conditions: endometriosis.The patient was prescribed Lupron Depot (drug dosage: NA), which was initiated on
Oct 30, 2013. Concurrently used drugs:
  • Norethindrone Acetate
.After starting to take Lupron Depot the consumer reported adverse symptoms, such as: Vulvovaginal Mycotic Infection, Pelvic PainThese side effects may potentially be related to Lupron Depot.
Lupron Side Effect Report#9993240
Endometriosis, Endometriosis, Amenorrhoea
This is a report of a 39-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: endometriosis, who was treated with Lupron Depot (dosage: NA, start time: 201309), combined with: NA. and developed a serious reaction and side effect(s): Endometriosis, Endometriosis, Amenorrhoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lupron Depot treatment in female patients, resulting in Endometriosis side effect.
Lupron Side Effect Report#9993238
Ear Infection
This report suggests a potential Lupron Depot Ear Infection side effect(s) that can have serious consequences. A 26-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: endometriosis and used Lupron Depot (dosage: NA) starting 201307. After starting Lupron Depot the patient began experiencing various side effects, including: Ear InfectionAdditional drugs used concurrently:
  • Zoloft
Although Lupron Depot demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Ear Infection, may still occur.
Lupron Side Effect Report#9993235
Abdominal Pain, Hot Flush, Vomiting, Vaginal Haemorrhage, Vaginal Haemorrhage, Unevaluable Event, Urinary Tract Infection
This Abdominal Pain problem was reported by a consumer or non-health professional from Country Not Specified. A 37-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: endometriosis,uterine leiomyoma. On
Dec 17, 2013 this consumer started treatment with Lupron Depot (dosage: NA). The following drugs were being taken at the same time: NA. When using Lupron Depot, the patient experienced the following unwanted symptoms/side effects: Abdominal Pain, Hot Flush, Vomiting, Vaginal Haemorrhage, Vaginal Haemorrhage, Unevaluable Event, Urinary Tract InfectionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Pain, may become evident only after a product is in use by the general population.
Lupron Side Effect Report#9993234
Abdominal Pain, Hot Flush, Breast Enlargement, Weight Decreased
This Abdominal Pain side effect was reported by a consumer or non-health professional from Country Not Specified. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: endometriosis,depression,nausea.The patient was prescribed Lupron Depot (drug dosage: NA), which was initiated on 201210. Concurrently used drugs:
  • Citalopram
  • Phenergan
.After starting to take Lupron Depot the consumer reported adverse symptoms, such as: Abdominal Pain, Hot Flush, Breast Enlargement, Weight DecreasedThese side effects may potentially be related to Lupron Depot.
Lupron Side Effect Report#9993233
Pelvic Pain
This is a report of a 37-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: endometriosis,pain, who was treated with Lupron Depot (dosage: NA, start time:
Feb 10, 2014), combined with:
  • Ultram (Daily)
  • Norethindrone Acetate
and developed a serious reaction and side effect(s): Pelvic Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lupron Depot treatment in female patients, resulting in Pelvic Pain side effect.
Lupron Side Effect Report#9993230
Vaginal Haemorrhage
This report suggests a potential Lupron Depot Vaginal Haemorrhage side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: endometriosis and used Lupron Depot (dosage: 3 Month) starting
Jan 23, 2014. After starting Lupron Depot the patient began experiencing various side effects, including: Vaginal HaemorrhageAdditional drugs used concurrently:
  • Norethindrone Acetate
  • Norethindrone Acetate
  • Norethindrone Acetate
Although Lupron Depot demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Vaginal Haemorrhage, may still occur.
Lupron Side Effect Report#9993229
Hot Flush
This Hot Flush problem was reported by a pharmacist from US. A 29-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: uterine leiomyoma. On
Oct 03, 2013 this consumer started treatment with Lupron Depot (dosage: NA). The following drugs were being taken at the same time:
  • Nuvaring
When using Lupron Depot, the patient experienced the following unwanted symptoms/side effects: Hot FlushAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hot Flush, may become evident only after a product is in use by the general population.
Lupron Side Effect Report#9993227
Vaginal Haemorrhage
This Vaginal Haemorrhage side effect was reported by a consumer or non-health professional from Country Not Specified. A 29-year-old female patient (weight:NA) experienced the following symptoms/conditions: endometriosis.The patient was prescribed Lupron Depot (drug dosage: NA), which was initiated on 201312. Concurrently used drugs:
  • Norethindrone
.After starting to take Lupron Depot the consumer reported adverse symptoms, such as: Vaginal HaemorrhageThese side effects may potentially be related to Lupron Depot.
Lupron Side Effect Report#9993224
Menorrhagia
This is a report of a 39-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: endometriosis,asthma, who was treated with Lupron Depot (dosage: NA, start time:
Dec 30, 2013), combined with:
  • Albuterol
and developed a serious reaction and side effect(s): Menorrhagia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lupron Depot treatment in female patients, resulting in Menorrhagia side effect.
Lupron Side Effect Report#9993221
Weight Increased, Emotional Disorder, Affect Lability, Poor Quality Sleep, Micturition Urgency, Urinary Incontinence, Peau D^orange, Anxiety, Stress
This report suggests a potential Lupron Depot Weight Increased side effect(s) that can have serious consequences. A 49-year-old female patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: vaginal haemorrhage,uterine leiomyoma,uterine disorder and used Lupron Depot (dosage: NA) starting 2009. After starting Lupron Depot the patient began experiencing various side effects, including: Weight Increased, Emotional Disorder, Affect Lability, Poor Quality Sleep, Micturition Urgency, Urinary Incontinence, Peau D^orange, Anxiety, StressAdditional drugs used concurrently: NA. Although Lupron Depot demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Weight Increased, may still occur.
Lupron Side Effect Report#9993220
Migraine, Nausea, Vomiting
This Migraine problem was reported by a consumer or non-health professional from Country Not Specified. A 35-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: endometriosis. On
Dec 04, 2013 this consumer started treatment with Lupron Depot (dosage: NA). The following drugs were being taken at the same time:
  • Flonase
  • Singulair
  • Cymbalta
  • Topamax
  • Vitamin D
  • Multivitamin
When using Lupron Depot, the patient experienced the following unwanted symptoms/side effects: Migraine, Nausea, VomitingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Migraine, may become evident only after a product is in use by the general population.
Lupron Side Effect Report#9993218
Hypomenorrhoea, Menorrhagia
This Hypomenorrhoea side effect was reported by a consumer or non-health professional from Country Not Specified. A 44-year-old female patient (weight:NA) experienced the following symptoms/conditions: premenstrual syndrome.The patient was prescribed Lupron Depot (drug dosage: NA), which was initiated on
Sep 09, 2013. Concurrently used drugs: NA..After starting to take Lupron Depot the consumer reported adverse symptoms, such as: Hypomenorrhoea, MenorrhagiaThese side effects may potentially be related to Lupron Depot.
Lupron Side Effect Report#9993216
Off Label Use, Menstrual Disorder, Dysmenorrhoea, Vaginal Haemorrhage, Thrombosis, Fatigue
This is a report of a 52-year-old female patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: menorrhagia,uterine leiomyoma,vitamin supplementation,gastrooesophageal reflux disease,anxiety,constipation, who was treated with Lupron Depot (dosage: NA, start time: 2012), combined with: NA. and developed a serious reaction and side effect(s): Off Label Use, Menstrual Disorder, Dysmenorrhoea, Vaginal Haemorrhage, Thrombosis, Fatigue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Lupron Depot treatment in female patients, resulting in Off Label Use side effect.


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The appearance of Lupron on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Lupron Side Effects for Women?

Women Side Effects Reports
Hot Flush 531
Headache 338
Vaginal Haemorrhage 249
Pain 235
Nausea 229
Arthralgia 213
Abdominal Pain 194
Fatigue 157
Insomnia 145
Menorrhagia 142

What are common Lupron Side Effects for Men?

Men Side Effects Reports
Hot Flush 179
Death 137
Asthenia 116
Fatigue 98
Prostate Cancer 87
Fall 86
Prostate Cancer Metastatic 80
Arthralgia 79
Prostatic Specific Antigen Increased 77
Pain 70

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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.

    Lupron reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Lupron Safety Alerts, Active Ingredients, Usage Information

    NDC 0074-2108
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Lupron Depot-PED
    Name leuprolide acetate
    Dosage Form KIT
    Route
    On market since 19930416
    Labeler AbbVie Inc.
    Active Ingredient(s)
    Strength(s)
    Unit(s)
    Pharma Class

    Lupron Dosage, Warnings, Usage.

    Side Effects reported to FDA: 4550

    Lupron safety alerts: No

    Reported deaths: 396

    Reported hospitalizations: 742

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