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Lupron Adverse Events Reported to the FDA Over Time

How are Lupron adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Lupron, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Lupron is flagged as the suspect drug causing the adverse event.

Most Common Lupron Adverse Events Reported to the FDA

What are the most common Lupron adverse events reported to the FDA?

Hot Flush
1064 (3.34%)
Headache
746 (2.34%)
Fatigue
486 (1.52%)
Pain
433 (1.36%)
Arthralgia
406 (1.27%)
Nausea
371 (1.16%)
Asthenia
332 (1.04%)
Weight Increased
315 (.99%)
Prostate Cancer
308 (.97%)
Insomnia
290 (.91%)
Dizziness
280 (.88%)
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Drug Ineffective
275 (.86%)
Death
274 (.86%)
Depression
255 (.8%)
Pain In Extremity
254 (.8%)
Dyspnoea
253 (.79%)
Abdominal Pain
248 (.78%)
Injection Site Pain
241 (.76%)
Vomiting
234 (.73%)
Back Pain
229 (.72%)
Oedema Peripheral
227 (.71%)
Feeling Abnormal
224 (.7%)
Pneumonia
221 (.69%)
Bone Pain
211 (.66%)
Vaginal Haemorrhage
205 (.64%)
Hypoaesthesia
193 (.61%)
Migraine
191 (.6%)
Prostatic Specific Antigen Increase...
191 (.6%)
Mood Swings
189 (.59%)
Malaise
178 (.56%)
Interstitial Lung Disease
176 (.55%)
Fall
169 (.53%)
Muscle Spasms
169 (.53%)
Myalgia
167 (.52%)
Night Sweats
167 (.52%)
Pyrexia
162 (.51%)
Abdominal Distension
157 (.49%)
Hyperhidrosis
148 (.46%)
Muscular Weakness
148 (.46%)
Menorrhagia
144 (.45%)
Anxiety
143 (.45%)
Paraesthesia
136 (.43%)
Diarrhoea
134 (.42%)
Gait Disturbance
128 (.4%)
Alopecia
126 (.4%)
General Physical Health Deteriorati...
125 (.39%)
Injection Site Erythema
125 (.39%)
Weight Decreased
122 (.38%)
Myocardial Infarction
121 (.38%)
Chest Pain
120 (.38%)
Metrorrhagia
117 (.37%)
Cerebrovascular Accident
115 (.36%)
Prostate Cancer Metastatic
114 (.36%)
Injection Site Induration
113 (.35%)
Anaemia
110 (.34%)
Hypertension
110 (.34%)
Injection Site Swelling
110 (.34%)
Rash
109 (.34%)
Condition Aggravated
108 (.34%)
Cardiac Failure
106 (.33%)
Vision Blurred
106 (.33%)
Decreased Appetite
105 (.33%)
Haemorrhage
102 (.32%)
Metastases To Bone
102 (.32%)
Crying
98 (.31%)
Blood Pressure Increased
97 (.3%)
Endometriosis
96 (.3%)
Memory Impairment
95 (.3%)
Amnesia
89 (.28%)
Cerebral Infarction
86 (.27%)
Menstrual Disorder
84 (.26%)
Urticaria
84 (.26%)
Pruritus
83 (.26%)
Hospitalisation
82 (.26%)
Unevaluable Event
82 (.26%)
Constipation
81 (.25%)
Irritability
81 (.25%)
Confusional State
80 (.25%)
Renal Failure
79 (.25%)
Abasia
75 (.24%)
Musculoskeletal Stiffness
75 (.24%)
Pelvic Pain
73 (.23%)
Mobility Decreased
72 (.23%)
Mood Altered
72 (.23%)
Joint Swelling
69 (.22%)
Incorrect Dose Administered
68 (.21%)
Injection Site Abscess
68 (.21%)
Loss Of Consciousness
68 (.21%)
Pulmonary Embolism
67 (.21%)
Urinary Tract Infection
67 (.21%)
Abdominal Pain Upper
66 (.21%)
Palpitations
65 (.2%)
Thrombosis
65 (.2%)
Tremor
65 (.2%)
Drug Dispensing Error
64 (.2%)
Lung Neoplasm Malignant
64 (.2%)
Aspartate Aminotransferase Increase...
62 (.19%)
Cough
62 (.19%)
Injection Site Nodule
61 (.19%)
Musculoskeletal Pain
61 (.19%)
Chest Discomfort
60 (.19%)

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This graph shows the top adverse events submitted to the FDA for Lupron, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Lupron is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Lupron

What are the most common Lupron adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Lupron, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Lupron is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Lupron According to Those Reporting Adverse Events

Why are people taking Lupron, according to those reporting adverse events to the FDA?

Prostate Cancer
3365
Endometriosis
1562
Product Used For Unknown Indication
1250
Uterine Leiomyoma
600
Prostate Cancer Stage Iv
383
Precocious Puberty
331
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Prostate Cancer Stage Ii
308
Drug Use For Unknown Indication
302
Prostate Cancer Stage Iii
162
Breast Cancer
139
Menorrhagia
94
Hormone Therapy
88
Prostate Cancer Metastatic
83
Pelvic Pain
80
In Vitro Fertilisation
59
Prostatic Intraepithelial Neoplasia
53
Ovarian Cyst
45
Prostatic Specific Antigen Increase...
39
Dysmenorrhoea
35
Anaemia
32
Infertility
30
Prostate Cancer Stage I
30
Vaginal Haemorrhage
27
Prophylaxis
22
Haemorrhage
22
Drug Exposure During Pregnancy
20
Spinal Muscular Atrophy
19
Uterine Haemorrhage
19
Polycystic Ovaries
18
Hormone Suppression Therapy
17
Neoplasm Malignant
17
Adenomyosis
15
Breast Cancer Female
14
Infertility Female
14
Ovarian Disorder
14
Metastases To Bone
12
Pain
11
Contraception
11
Premenstrual Syndrome
11
Menopause
11
Antiandrogen Therapy
10
Artificial Menopause
10
Ill-defined Disorder
9
Abdominal Pain
9
Prostate Cancer Recurrent
9
Prostatic Adenoma
9
Migraine
9
Menstrual Disorder
9
Menstrual Cycle Management
9
Prostatic Disorder
9
Cyst Removal
9

Drug Labels

LabelLabelerEffective
Lupron Depot PedTakeda Pharmaceutical Company LTD07-JAN-11
Lupron Depot-pedAbbott Laboratories17-AUG-11
Lupron Depot-pedAbbott Laboratories13-OCT-11
Lupron DepotAbbott Laboratories04-APR-12
Lupron DepotAbbott Laboratories04-APR-12
Lupron DepotAbbott Laboratories22-MAY-12
Lupron DepotAbbott Laboratories13-AUG-12

Lupron Case Reports

What Lupron safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Lupron. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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