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CLOMIPHENE CITRATE

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Clomiphene Citrate Adverse Events Reported to the FDA Over Time

How are Clomiphene Citrate adverse event reports trending over time?

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

Most Common Clomiphene Citrate Adverse Events Reported to the FDA

What are the most common Clomiphene Citrate adverse events reported to the FDA?

Drug Exposure During Pregnancy
131 (6.66%)
Abortion Spontaneous
75 (3.81%)
Pregnancy
55 (2.79%)
Premature Baby
41 (2.08%)
Ovarian Hyperstimulation Syndrome
36 (1.83%)
Ectopic Pregnancy
29 (1.47%)
Caesarean Section
27 (1.37%)
Headache
27 (1.37%)
Abortion Induced
26 (1.32%)
Maternal Drugs Affecting Foetus
22 (1.12%)
Multiple Pregnancy
21 (1.07%)
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Twin Pregnancy
20 (1.02%)
Congenital Anomaly
19 (.97%)
Drug Exposure Before Pregnancy
19 (.97%)
Nausea
18 (.91%)
Ruptured Ectopic Pregnancy
17 (.86%)
Off Label Use
16 (.81%)
Heterotopic Pregnancy
14 (.71%)
Drug Ineffective
13 (.66%)
Vision Blurred
13 (.66%)
Dizziness
12 (.61%)
Neonatal Respiratory Distress Syndr...
12 (.61%)
Polycythaemia Vera
12 (.61%)
Retinopathy Of Prematurity
12 (.61%)
Alanine Aminotransferase Increased
11 (.56%)
Alopecia
11 (.56%)
Aspartate Aminotransferase Increase...
11 (.56%)
Ovarian Cyst
11 (.56%)
Ascites
10 (.51%)
Hot Flush
10 (.51%)
Abdominal Distension
9 (.46%)
Completed Suicide
9 (.46%)
Conjoined Twins
9 (.46%)
Photophobia
9 (.46%)
Pleural Effusion
9 (.46%)
Vomiting
9 (.46%)
Weight Increased
9 (.46%)
Abdominal Pain
8 (.41%)
Abdominal Pain Lower
8 (.41%)
Abortion Threatened
8 (.41%)
Arthralgia
8 (.41%)
Blood Testosterone Increased
8 (.41%)
Delirium
8 (.41%)
Drug Toxicity
8 (.41%)
Dyspnoea
8 (.41%)
Intra-uterine Death
8 (.41%)
Ovarian Torsion
8 (.41%)
Peritoneal Haemorrhage
8 (.41%)
Tremor
8 (.41%)
Visual Impairment
8 (.41%)
Benign Hydatidiform Mole
7 (.36%)
Breast Cancer Female
7 (.36%)
Bronchopulmonary Dysplasia
7 (.36%)
Convulsion
7 (.36%)
Drug Withdrawal Syndrome Neonatal
7 (.36%)
Iridocyclitis
7 (.36%)
Myocardial Infarction
7 (.36%)
Neonatal Disorder
7 (.36%)
Optic Neuritis
7 (.36%)
Pancreatitis Acute
7 (.36%)
Papilloedema
7 (.36%)
Premature Labour
7 (.36%)
Abdominal Discomfort
6 (.3%)
Anaemia
6 (.3%)
Blood Bilirubin Increased
6 (.3%)
Deep Vein Thrombosis
6 (.3%)
Eye Pain
6 (.3%)
Haemorrhage
6 (.3%)
Hallucination
6 (.3%)
Medication Error
6 (.3%)
Pain
6 (.3%)
Placental Transfusion Syndrome
6 (.3%)
Retinal Vein Occlusion
6 (.3%)
Stillbirth
6 (.3%)
White Blood Cell Count Increased
6 (.3%)
Anxiety
5 (.25%)
Breast Tenderness
5 (.25%)
Cardiac Arrest
5 (.25%)
Foetal Growth Retardation
5 (.25%)
Intraventricular Haemorrhage
5 (.25%)
Myalgia
5 (.25%)
Mydriasis
5 (.25%)
Palpitations
5 (.25%)
Pulmonary Embolism
5 (.25%)
Respiratory Arrest
5 (.25%)
Syndactyly
5 (.25%)
Abortion Missed
4 (.2%)
Apgar Score Low
4 (.2%)
Blood Albumin Decreased
4 (.2%)
Body Temperature Increased
4 (.2%)
Cerebrovascular Accident
4 (.2%)
Cor Pulmonale Acute
4 (.2%)
Craniosynostosis
4 (.2%)
Crying
4 (.2%)
Depression
4 (.2%)
Diarrhoea
4 (.2%)
Eye Inflammation
4 (.2%)
Feeling Abnormal
4 (.2%)
Genital Haemorrhage
4 (.2%)
Haematocrit Increased
4 (.2%)
Haemoptysis
4 (.2%)

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This graph shows the top adverse events submitted to the FDA for Clomiphene Citrate, 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 Clomiphene Citrate 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 Clomiphene Citrate

What are the most common Clomiphene Citrate adverse events reported to the FDA?

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

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

Ovulation Induction
102
Infertility
98
Anovulatory Cycle
44
Product Used For Unknown Indication
40
Polycystic Ovaries
37
Infertility Female
21
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In Vitro Fertilisation
19
Drug Use For Unknown Indication
19
Assisted Fertilisation
14
Ovarian Disorder
6
Artificial Insemination By Partner
5
Drug Exposure During Pregnancy
5
Infertility Male
4
Hypogonadism Male
4
Ovulation Disorder
4
Pregnancy
3
Sperm Count Decreased
3
Infertility Tests
2
Ill-defined Disorder
2
Teratospermia
2
Azoospermia
2
Off Label Use
2
Ovarian Failure
2
Hypogonadism
1
Asthenospermia
1
Hormone Therapy
1
Amenorrhoea
1
Erectile Dysfunction
1
Andropause
1
Hormone Replacement Therapy
1
Drug Therapy
1
Convulsion
1
Luteal Phase Deficiency
1
Androgen Deficiency
1
Drug Dispensing Error
1
Spermatozoa Abnormal
1

Drug Labels

LabelLabelerEffective
Clomiphene CitratePhysicians Total Care, Inc.17-SEP-09
Clomiphene CitrateRebel Distributors Corp23-SEP-10
SeropheneEMD Serono, Inc.01-FEB-11
Clomiphene CitratePD-Rx Pharmaceuticals, Inc.16-JUL-12
Clomiphene CitrateTeva Pharmaceuticals USA Inc01-AUG-12
Clomidsanofi-aventis U.S. LLC12-NOV-12
Clomiphene CitrateWatson Laboratories, Inc.04-MAR-13
Clomiphene CitratePar Pharmaceutical Inc15-MAR-13

Clomiphene Citrate Case Reports

What Clomiphene Citrate 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 Clomiphene Citrate. 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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