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DEPO PROVERA

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Depo Provera Adverse Events Reported to the FDA Over Time

How are Depo Provera adverse event reports trending over time?

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

Most Common Depo Provera Adverse Events Reported to the FDA

What are the most common Depo Provera adverse events reported to the FDA?

Breast Cancer
1270 (5.02%)
Breast Cancer Female
1226 (4.85%)
Unintended Pregnancy
758 (3%)
Amenorrhoea
563 (2.23%)
Drug Ineffective
494 (1.95%)
Weight Increased
493 (1.95%)
Metrorrhagia
420 (1.66%)
Osteoporosis
393 (1.55%)
Menorrhagia
389 (1.54%)
Headache
373 (1.48%)
Depression
311 (1.23%)
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Drug Exposure During Pregnancy
271 (1.07%)
Nausea
266 (1.05%)
Dizziness
259 (1.02%)
Pregnancy With Injectable Contracep...
202 (.8%)
Pain
199 (.79%)
Abortion Spontaneous
198 (.78%)
Inappropriate Schedule Of Drug Admi...
195 (.77%)
Anxiety
184 (.73%)
Fatigue
182 (.72%)
Osteopenia
175 (.69%)
Alopecia
174 (.69%)
Arthralgia
160 (.63%)
Dyspnoea
154 (.61%)
Vomiting
142 (.56%)
Vaginal Haemorrhage
140 (.55%)
Back Pain
139 (.55%)
Bone Density Decreased
136 (.54%)
Insomnia
130 (.51%)
Pain In Extremity
129 (.51%)
Abdominal Pain
125 (.49%)
Malaise
125 (.49%)
Asthenia
122 (.48%)
Injection Site Pain
122 (.48%)
Haemorrhage
117 (.46%)
Hot Flush
117 (.46%)
Migraine
115 (.45%)
Weight Decreased
115 (.45%)
Mood Swings
113 (.45%)
Feeling Abnormal
112 (.44%)
Hypertension
112 (.44%)
Breast Cancer Metastatic
110 (.44%)
Nervousness
110 (.44%)
Pulmonary Embolism
109 (.43%)
Menstruation Irregular
108 (.43%)
Abdominal Distension
106 (.42%)
Urticaria
105 (.42%)
Oedema Peripheral
101 (.4%)
Rash
101 (.4%)
Thrombosis
98 (.39%)
Condition Aggravated
95 (.38%)
Hypersensitivity
94 (.37%)
Chest Pain
93 (.37%)
Pruritus
93 (.37%)
Breast Operation
92 (.36%)
Breast Cancer In Situ
90 (.36%)
Hypoaesthesia
89 (.35%)
Acne
88 (.35%)
Dysmenorrhoea
88 (.35%)
Incorrect Dose Administered
88 (.35%)
Muscle Spasms
83 (.33%)
Pelvic Pain
83 (.33%)
Anaemia
81 (.32%)
Injection Site Abscess
81 (.32%)
Syncope
77 (.3%)
Tremor
77 (.3%)
Irritability
76 (.3%)
Ovarian Cancer
73 (.29%)
Drug Ineffective For Unapproved Ind...
72 (.28%)
Paraesthesia
71 (.28%)
Infertility Female
68 (.27%)
Oestrogen Receptor Assay Positive
68 (.27%)
Injection Site Reaction
67 (.27%)
Abdominal Pain Upper
66 (.26%)
Mastectomy
66 (.26%)
Cerebrovascular Accident
65 (.26%)
Suicidal Ideation
65 (.26%)
Swelling
65 (.26%)
Convulsion
63 (.25%)
Ovarian Cyst
63 (.25%)
Mood Altered
62 (.25%)
Blood Pressure Increased
59 (.23%)
Breast Pain
59 (.23%)
Pyrexia
57 (.23%)
Menometrorrhagia
56 (.22%)
Pregnancy
56 (.22%)
Crying
55 (.22%)
Emotional Disorder
54 (.21%)
Deep Vein Thrombosis
53 (.21%)
Loss Of Consciousness
53 (.21%)
Bone Pain
52 (.21%)
Drug Interaction
52 (.21%)
Hyperhidrosis
52 (.21%)
Progesterone Receptor Assay Positiv...
51 (.2%)
Vision Blurred
51 (.2%)
Erythema
50 (.2%)
Somnolence
50 (.2%)
Stress
50 (.2%)
Urinary Tract Infection
50 (.2%)
Uterine Leiomyoma
50 (.2%)
Diarrhoea
49 (.19%)

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This graph shows the top adverse events submitted to the FDA for Depo Provera, 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 Depo Provera 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 Depo Provera

What are the most common Depo Provera adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Depo Provera, 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 Depo Provera 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 Depo Provera According to Those Reporting Adverse Events

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

Hormone Replacement Therapy
6528
Contraception
3594
Menopausal Symptoms
481
Menopause
370
Off Label Use
222
Ill-defined Disorder
189
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Menstrual Discomfort
167
Drug Use For Unknown Indication
155
Menorrhagia
128
Endometriosis
127
Product Used For Unknown Indication
93
Breast Cancer
54
Uterine Leiomyoma
53
Dysmenorrhoea
52
Menstruation Irregular
44
Premenstrual Syndrome
26
Menstrual Disorder
22
Hormone Therapy
22
Hot Flush
21
Prophylaxis
19
Breast Cancer Metastatic
19
Amenorrhoea
18
Menstrual Cycle Management
17
Ovarian Cyst
17
Osteoporosis
17
Uterine Haemorrhage
16
Vaginal Haemorrhage
14
Breast Cancer Recurrent
14
Endometrial Hyperplasia
13
Polycystic Ovaries
13
Migraine
12
Osteoporosis Prophylaxis
11
Pelvic Pain
11
Anorexia
11
Lymphangioleiomyomatosis
10
Uterine Cancer
10
Injectable Contraception
9
Cardiac Disorder
9
Endometrial Cancer
9
Sexual Abuse
7
Oestrogen Replacement Therapy
7
Haemorrhage
6
Anaemia
6
Decreased Appetite
6
Dysfunctional Uterine Bleeding
6
Oral Contraception
6
Hormone Level Abnormal
6
Hysterectomy
6
Metastases To Bone
6
Pregnancy
5
Increased Appetite
5

Drug Labels

LabelLabelerEffective
Depo-proveraPhysicians Total Care, Inc.12-AUG-09
Depo-proveraPharmacia and Upjohn Company12-AUG-09
Depo-proveraPhysicians Total Care, Inc.27-OCT-10
Depo-proveraPharmacia and Upjohn Company26-JUN-12

Depo Provera Case Reports

What Depo Provera 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 Depo Provera. 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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