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LUPRON DEPOT

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Lupron Depot Adverse Events Reported to the FDA Over Time

How are Lupron Depot adverse event reports trending over time?

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

Most Common Lupron Depot Adverse Events Reported to the FDA

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

Hot Flush
945 (3.29%)
Headache
610 (2.13%)
Fatigue
395 (1.38%)
Pain
374 (1.3%)
Arthralgia
346 (1.21%)
Nausea
319 (1.11%)
Asthenia
303 (1.06%)
Prostate Cancer
299 (1.04%)
Weight Increased
274 (.95%)
Death
266 (.93%)
Drug Ineffective
258 (.9%)
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Dizziness
256 (.89%)
Insomnia
256 (.89%)
Abdominal Pain
231 (.8%)
Dyspnoea
228 (.79%)
Depression
222 (.77%)
Injection Site Pain
222 (.77%)
Pain In Extremity
222 (.77%)
Pneumonia
217 (.76%)
Oedema Peripheral
215 (.75%)
Vomiting
203 (.71%)
Vaginal Haemorrhage
201 (.7%)
Back Pain
191 (.67%)
Prostatic Specific Antigen Increase...
178 (.62%)
Bone Pain
177 (.62%)
Feeling Abnormal
174 (.61%)
Hypoaesthesia
174 (.61%)
Interstitial Lung Disease
174 (.61%)
Migraine
165 (.57%)
Fall
155 (.54%)
Pyrexia
155 (.54%)
Mood Swings
154 (.54%)
Malaise
153 (.53%)
Muscle Spasms
147 (.51%)
Night Sweats
140 (.49%)
Menorrhagia
139 (.48%)
Myalgia
138 (.48%)
Muscular Weakness
134 (.47%)
Hyperhidrosis
133 (.46%)
Abdominal Distension
131 (.46%)
Diarrhoea
125 (.44%)
Paraesthesia
124 (.43%)
General Physical Health Deteriorati...
121 (.42%)
Injection Site Erythema
119 (.41%)
Anxiety
117 (.41%)
Gait Disturbance
117 (.41%)
Metrorrhagia
114 (.4%)
Injection Site Induration
112 (.39%)
Myocardial Infarction
112 (.39%)
Prostate Cancer Metastatic
112 (.39%)
Cerebrovascular Accident
109 (.38%)
Cardiac Failure
106 (.37%)
Chest Pain
105 (.37%)
Weight Decreased
105 (.37%)
Alopecia
104 (.36%)
Rash
104 (.36%)
Injection Site Swelling
103 (.36%)
Condition Aggravated
101 (.35%)
Anaemia
100 (.35%)
Hypertension
100 (.35%)
Decreased Appetite
97 (.34%)
Metastases To Bone
97 (.34%)
Vision Blurred
97 (.34%)
Haemorrhage
96 (.33%)
Blood Pressure Increased
94 (.33%)
Cerebral Infarction
85 (.3%)
Endometriosis
84 (.29%)
Hospitalisation
81 (.28%)
Menstrual Disorder
79 (.28%)
Urticaria
79 (.28%)
Constipation
77 (.27%)
Renal Failure
77 (.27%)
Crying
75 (.26%)
Amnesia
74 (.26%)
Confusional State
73 (.25%)
Unevaluable Event
73 (.25%)
Mobility Decreased
72 (.25%)
Pruritus
72 (.25%)
Abasia
70 (.24%)
Memory Impairment
70 (.24%)
Injection Site Abscess
68 (.24%)
Incorrect Dose Administered
66 (.23%)
Pelvic Pain
66 (.23%)
Joint Swelling
63 (.22%)
Lung Neoplasm Malignant
63 (.22%)
Musculoskeletal Stiffness
63 (.22%)
Urinary Tract Infection
63 (.22%)
Cough
61 (.21%)
Drug Dispensing Error
61 (.21%)
Loss Of Consciousness
61 (.21%)
Aspartate Aminotransferase Increase...
59 (.21%)
Injection Site Nodule
59 (.21%)
Palpitations
59 (.21%)
Pulmonary Embolism
59 (.21%)
Thrombosis
59 (.21%)
Chest Discomfort
58 (.2%)
Irritability
58 (.2%)
Tremor
58 (.2%)
Prostate Cancer Stage Iv
57 (.2%)
Abdominal Pain Upper
55 (.19%)
Musculoskeletal Pain
55 (.19%)

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This graph shows the top adverse events submitted to the FDA for Lupron Depot, 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 Depot 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 Depot

What are the most common Lupron Depot 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 Depot, 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 Depot 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 Depot According to Those Reporting Adverse Events

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

Prostate Cancer
2973
Endometriosis
1455
Product Used For Unknown Indication
962
Uterine Leiomyoma
567
Prostate Cancer Stage Iv
383
Precocious Puberty
311
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Prostate Cancer Stage Ii
308
Drug Use For Unknown Indication
245
Prostate Cancer Stage Iii
162
Breast Cancer
129
Menorrhagia
91
Pelvic Pain
75
Hormone Therapy
59
Prostatic Intraepithelial Neoplasia
53
Prostate Cancer Metastatic
51
Ovarian Cyst
44
Prostatic Specific Antigen Increase...
38
Dysmenorrhoea
32
Prostate Cancer Stage I
30
Anaemia
29
In Vitro Fertilisation
28
Vaginal Haemorrhage
26
Haemorrhage
22
Infertility
22
Prophylaxis
20
Spinal Muscular Atrophy
19
Polycystic Ovaries
17
Uterine Haemorrhage
16
Drug Exposure During Pregnancy
16
Ovarian Disorder
14
Breast Cancer Female
14
Adenomyosis
13
Pain
11
Antiandrogen Therapy
10
Metastases To Bone
10
Migraine
9
Cyst Removal
9
Prostatic Adenoma
9
Menopause
9
Abdominal Pain
8
Premenstrual Syndrome
8
Prostatic Disorder
8
Prostatectomy
8
Artificial Menopause
8
Menstrual Disorder
8
Menstrual Cycle Management
7
Infertility Female
7
Dysfunctional Uterine Bleeding
6
Uterine Enlargement
6
Prostate Cancer Recurrent
6
Reproductive Tract Disorder
6

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 Depot Case Reports

What Lupron Depot 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 Depot. 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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