CLOMID

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Clomid Adverse Events Reported to the FDA Over Time

How are Clomid adverse event reports trending over time?

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

Most Common Clomid Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	114 (6.35%)
Abortion Spontaneous	51 (2.84%)
Pregnancy	49 (2.73%)
Premature Baby	40 (2.23%)
Ovarian Hyperstimulation Syndrome	32 (1.78%)
Caesarean Section	27 (1.51%)
Abortion Induced	24 (1.34%)
Ectopic Pregnancy	24 (1.34%)
Headache	24 (1.34%)
Multiple Pregnancy	21 (1.17%)
Twin Pregnancy	20 (1.11%)
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Congenital Anomaly	18 (1%)
Maternal Drugs Affecting Foetus	17 (.95%)
Nausea	16 (.89%)
Off Label Use	16 (.89%)
Ruptured Ectopic Pregnancy	16 (.89%)
Drug Exposure Before Pregnancy	15 (.84%)
Heterotopic Pregnancy	14 (.78%)
Vision Blurred	13 (.72%)
Drug Ineffective	12 (.67%)
Neonatal Respiratory Distress Syndr...	12 (.67%)
Polycythaemia Vera	12 (.67%)
Retinopathy Of Prematurity	12 (.67%)
Alanine Aminotransferase Increased	11 (.61%)
Aspartate Aminotransferase Increase...	11 (.61%)
Alopecia	10 (.56%)
Ascites	10 (.56%)
Hot Flush	10 (.56%)
Abdominal Distension	9 (.5%)
Completed Suicide	9 (.5%)
Conjoined Twins	9 (.5%)
Photophobia	9 (.5%)
Pleural Effusion	9 (.5%)
Weight Increased	9 (.5%)
Abdominal Pain Lower	8 (.45%)
Abortion Threatened	8 (.45%)
Arthralgia	8 (.45%)
Blood Testosterone Increased	8 (.45%)
Delirium	8 (.45%)
Dizziness	8 (.45%)
Peritoneal Haemorrhage	8 (.45%)
Tremor	8 (.45%)
Benign Hydatidiform Mole	7 (.39%)
Breast Cancer Female	7 (.39%)
Bronchopulmonary Dysplasia	7 (.39%)
Drug Toxicity	7 (.39%)
Drug Withdrawal Syndrome Neonatal	7 (.39%)
Dyspnoea	7 (.39%)
Intra-uterine Death	7 (.39%)
Iridocyclitis	7 (.39%)
Myocardial Infarction	7 (.39%)
Neonatal Disorder	7 (.39%)
Optic Neuritis	7 (.39%)
Ovarian Cyst	7 (.39%)
Ovarian Torsion	7 (.39%)
Pancreatitis Acute	7 (.39%)
Papilloedema	7 (.39%)
Premature Labour	7 (.39%)
Vomiting	7 (.39%)
Anaemia	6 (.33%)
Blood Bilirubin Increased	6 (.33%)
Convulsion	6 (.33%)
Deep Vein Thrombosis	6 (.33%)
Eye Pain	6 (.33%)
Haemorrhage	6 (.33%)
Hallucination	6 (.33%)
Placental Transfusion Syndrome	6 (.33%)
Retinal Vein Occlusion	6 (.33%)
White Blood Cell Count Increased	6 (.33%)
Abdominal Discomfort	5 (.28%)
Anxiety	5 (.28%)
Breast Tenderness	5 (.28%)
Cardiac Arrest	5 (.28%)
Intraventricular Haemorrhage	5 (.28%)
Medication Error	5 (.28%)
Myalgia	5 (.28%)
Mydriasis	5 (.28%)
Pain	5 (.28%)
Palpitations	5 (.28%)
Respiratory Arrest	5 (.28%)
Stillbirth	5 (.28%)
Syndactyly	5 (.28%)
Visual Impairment	5 (.28%)
Abdominal Pain	4 (.22%)
Abortion Missed	4 (.22%)
Apgar Score Low	4 (.22%)
Blood Albumin Decreased	4 (.22%)
Body Temperature Increased	4 (.22%)
Craniosynostosis	4 (.22%)
Crying	4 (.22%)
Depression	4 (.22%)
Eye Inflammation	4 (.22%)
Feeling Abnormal	4 (.22%)
Foetal Growth Retardation	4 (.22%)
Genital Haemorrhage	4 (.22%)
Haematocrit Increased	4 (.22%)
Haemoptysis	4 (.22%)
Hepatic Failure	4 (.22%)
Hypertension	4 (.22%)
Limb Reduction Defect	4 (.22%)
Mania	4 (.22%)

Share/Embed Graph Export Data

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

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

Chemical Injury And Poisoning	157 (8.75%)
Pregnancy, Labour, Delivery And Pos...	94 (5.24%)
Abortions And Stillbirth	83 (4.63%)
Maternal Complications Of Pregnancy	62 (3.46%)
Ovarian And Fallopian Tube	61 (3.4%)
Obstetric And Gynecological Therape...	54 (3.01%)
Neonatal And Perinatal Conditions	53 (2.95%)
Gastrointestinal Signs	52 (2.9%)
Hematology Investigations	35 (1.95%)
Neurological	33 (1.84%)
Hepatobiliary	32 (1.78%)
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Musculoskeletal And Connective Tiss...	31 (1.73%)
Congenital And Hereditary	28 (1.56%)
Therapeutic And Nontherapeutic Effe...	27 (1.51%)
Vision	27 (1.51%)
Headaches	25 (1.39%)
Endocrine Investigations	23 (1.28%)
Ocular Structural Change, Deposit A...	20 (1.11%)
Neonatal Respiratory	19 (1.06%)
Peritoneal And Retroperitoneal Cond...	19 (1.06%)
Physical Examination Topics	19 (1.06%)
Respiratory	19 (1.06%)
Disturbances In Thinking	17 (.95%)
Central Nervous System Vascular	16 (.89%)
Skin Appendage Conditions	16 (.89%)
Therapeutic Procedures And Supporti...	16 (.89%)
Anxiety Disorders	15 (.84%)
Immunology And Allergy	15 (.84%)
Movement Disorders	15 (.84%)
Epidermal And Dermal Conditions	14 (.78%)
Ocular Infections, Irritations And ...	14 (.78%)
Vascular	13 (.72%)
Water, Electrolyte And Mineral	13 (.72%)
Exocrine Pancreas Conditions	12 (.67%)
Hematopoietic Neoplasms	12 (.67%)
Maternal Complications Of Labour An...	12 (.67%)
Renal And Urinary Tract Investigati...	12 (.67%)
Retina, Choroid And Vitreous Hemorr...	12 (.67%)
Suicidal And Self-injurious Behavio...	12 (.67%)
Deliria	11 (.61%)
Hepatic And Hepatobiliary	11 (.61%)
Medication Errors	11 (.61%)
Neurological Disorders Congenital	11 (.61%)
Protein And Chemistry Analyses	11 (.61%)
Uterine, Pelvic And Broad Ligament	11 (.61%)
Coronary Artery	10 (.56%)
Metabolic, Nutritional And Blood Ga...	10 (.56%)
Muscle	10 (.56%)
Pleural	10 (.56%)
Anemias Nonhemolytic And Marrow Dep...	9 (.5%)
Breast	9 (.5%)
Breast Neoplasms Malignant And Unsp...	9 (.5%)
Eye	9 (.5%)
Fetal Complications	9 (.5%)
Hematological	9 (.5%)
Joint	9 (.5%)
Ocular Sensory Symptoms	9 (.5%)
Reproductive Neoplasms Female Benig...	9 (.5%)
Urinary Tract Signs	9 (.5%)
Cardiac Arrhythmias	8 (.45%)
Cranial Nerve Disorders	8 (.45%)
Embolism And Thrombosis	8 (.45%)
Gastrointestinal Tract Disorders Co...	8 (.45%)
Procedural And Device Related Injur...	8 (.45%)
Cardiac And Vascular Investigations	7 (.39%)
Cardiac Disorder Signs	7 (.39%)
Increased Intracranial Pressure And...	7 (.39%)
Musculoskeletal And Connective Tiss...	7 (.39%)
Seizures	7 (.39%)
Vascular Hemorrhagic	7 (.39%)
Cardiac And Vascular Disorders Cong...	6 (.33%)
Depressed Mood Disorders	6 (.33%)
Eye Disorders Congenital	6 (.33%)
Mental Impairment	6 (.33%)
Reproductive Neoplasms Female Malig...	6 (.33%)
Sexual Function And Fertility	6 (.33%)
Menstrual Cycle And Uterine Bleedin...	5 (.28%)
Mood Disorders	5 (.28%)
Neurological Disorders Of The Eye	5 (.28%)
Ocular Neuromuscular	5 (.28%)
Placental, Amniotic And Cavity Diso...	5 (.28%)
Reproductive Tract	5 (.28%)
Respiratory Disorders Congenital	5 (.28%)
Appetite And General Nutritional	4 (.22%)
Body Temperature Conditions	4 (.22%)
Coagulopathies And Bleeding Diathes...	4 (.22%)
Cognitive And Attention Disorders	4 (.22%)
Connective Tissue Disorders	4 (.22%)
Electrolyte And Fluid Balance Condi...	4 (.22%)
Fetal And Neonatal	4 (.22%)
Gallbladder	4 (.22%)
Inner Ear And Viiith Cranial Nerve	4 (.22%)
Lipid Analyses	4 (.22%)
Lipid Metabolism	4 (.22%)
Lower Respiratory Tract Disorders	4 (.22%)
Manic And Bipolar Mood Disorders	4 (.22%)
Personality Disorders	4 (.22%)
Renal Disorders	4 (.22%)
Sleep Disorders	4 (.22%)
Vascular Hypertensive	4 (.22%)
Vulvovaginal Disorders	4 (.22%)

Share/Embed Graph Export Data

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

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

Ovulation Induction	94
Infertility	83
Polycystic Ovaries	37
Product Used For Unknown Indication	30
In Vitro Fertilisation	19
Infertility Female	19
	Show More
Drug Use For Unknown Indication	19
Anovulatory Cycle	18
Assisted Fertilisation	12
Ovarian Disorder	5
Drug Exposure During Pregnancy	5
Artificial Insemination By Partner	5
Infertility Male	4
Hypogonadism Male	4
Pregnancy	3
Ovulation Disorder	3
Sperm Count Decreased	3
Infertility Tests	2
Ill-defined Disorder	2
Ovarian Failure	2
Azoospermia	2
Teratospermia	2
Hypogonadism	1
Asthenospermia	1
Hormone Therapy	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

Label	Labeler	Effective
Clomid	sanofi-aventis U.S. LLC	12-NOV-12

Clomid Case Reports

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

About Results

This report contains aggregated drug side effects and adverse events for Clomid. 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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