PARAGARD T

Paragard T Adverse Events Reported to the FDA Over Time

How are Paragard T adverse event reports trending over time?

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

Most Common Paragard T Adverse Events Reported to the FDA

What are the most common Paragard T adverse events reported to the FDA?

Pregnancy With Contraceptive Device	107 (6.15%)
Device Dislocation	88 (5.05%)
Drug Ineffective	81 (4.65%)
Abdominal Pain	72 (4.14%)
Abortion Spontaneous	63 (3.62%)
Vaginal Haemorrhage	57 (3.27%)
Medical Device Complication	53 (3.04%)
Unintended Pregnancy	37 (2.13%)
Device Breakage	33 (1.9%)
Iucd Complication	33 (1.9%)
Ectopic Pregnancy	30 (1.72%)
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Drug Exposure During Pregnancy	29 (1.67%)
Menorrhagia	27 (1.55%)
Pain	27 (1.55%)
Pelvic Pain	27 (1.55%)
Metrorrhagia	23 (1.32%)
Uterine Haemorrhage	22 (1.26%)
Uterine Rupture	22 (1.26%)
Nausea	20 (1.15%)
Dizziness	17 (.98%)
Intra-uterine Contraceptive Device ...	16 (.92%)
Complication Of Device Removal	15 (.86%)
Muscle Spasms	15 (.86%)
Iud Migration	14 (.8%)
Abdominal Pain Lower	13 (.75%)
Loss Of Consciousness	13 (.75%)
Pyrexia	13 (.75%)
Vaginal Discharge	13 (.75%)
Breast Tenderness	12 (.69%)
Menstruation Irregular	11 (.63%)
Anxiety	10 (.57%)
Convulsion	10 (.57%)
Fatigue	10 (.57%)
Haemorrhage	10 (.57%)
Pelvic Inflammatory Disease	10 (.57%)
Caesarean Section	9 (.52%)
Pregnancy	9 (.52%)
Intra-uterine Death	8 (.46%)
Urticaria	8 (.46%)
Alopecia	7 (.4%)
Chills	7 (.4%)
Depression	7 (.4%)
Dysmenorrhoea	7 (.4%)
Fallopian Tube Disorder	7 (.4%)
Menstruation Delayed	7 (.4%)
Ovarian Cyst	7 (.4%)
Syncope	7 (.4%)
Uterine Spasm	7 (.4%)
Vomiting	7 (.4%)
Ectopic Pregnancy With Intrauterine...	6 (.34%)
Genital Haemorrhage	6 (.34%)
Menometrorrhagia	6 (.34%)
Ruptured Ectopic Pregnancy	6 (.34%)
Thrombosis	6 (.34%)
Uterine Leiomyoma	6 (.34%)
Weight Decreased	6 (.34%)
Abdominal Pain Upper	5 (.29%)
Amenorrhoea	5 (.29%)
Back Pain	5 (.29%)
Blood Copper Increased	5 (.29%)
Condition Aggravated	5 (.29%)
Dyspareunia	5 (.29%)
Gingival Pain	5 (.29%)
Loose Tooth	5 (.29%)
Placental Transfusion Syndrome	5 (.29%)
Premature Baby	5 (.29%)
Rash	5 (.29%)
Urinary Tract Infection	5 (.29%)
Vulvovaginal Pruritus	5 (.29%)
Abdominal Discomfort	4 (.23%)
Abortion Induced	4 (.23%)
Allergy To Metals	4 (.23%)
Arthralgia	4 (.23%)
Blighted Ovum	4 (.23%)
Cerebrovascular Accident	4 (.23%)
Cerumen Impaction	4 (.23%)
Complication Of Device Insertion	4 (.23%)
Developmental Delay	4 (.23%)
Discomfort	4 (.23%)
Erythema	4 (.23%)
Fall	4 (.23%)
Gastroenteritis	4 (.23%)
Gingival Swelling	4 (.23%)
Haemorrhagic Ovarian Cyst	4 (.23%)
Hypersensitivity	4 (.23%)
Infection	4 (.23%)
Maternal Drugs Affecting Foetus	4 (.23%)
Medication Error	4 (.23%)
Pallor	4 (.23%)
Pregnancy Test Positive	4 (.23%)
Pruritus	4 (.23%)
Toxic Shock Syndrome	4 (.23%)
Uterine Pain	4 (.23%)
Vaginal Infection	4 (.23%)
Vaginitis Bacterial	4 (.23%)
Abdominal Distension	3 (.17%)
Abortion	3 (.17%)
Acne	3 (.17%)
Affect Lability	3 (.17%)
Anaemia	3 (.17%)
Autoimmune Disorder	3 (.17%)

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

What are the most common Paragard T adverse events reported to the FDA?

Procedural And Device Related Injur...	260 (14.93%)
Pregnancy, Labour, Delivery And Pos...	163 (9.36%)
Gastrointestinal Signs	130 (7.47%)
Menstrual Cycle And Uterine Bleedin...	96 (5.51%)
Abortions And Stillbirth	84 (4.82%)
Therapeutic And Nontherapeutic Effe...	83 (4.77%)
Vulvovaginal Disorders	78 (4.48%)
Infections - Pathogen Unspecified	59 (3.39%)
Maternal Complications Of Pregnancy	46 (2.64%)
Uterine, Pelvic And Broad Ligament	46 (2.64%)
Neurological	43 (2.47%)
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Chemical Injury And Poisoning	36 (2.07%)
Reproductive Tract	34 (1.95%)
Injuries	31 (1.78%)
Epidermal And Dermal Conditions	28 (1.61%)
Ovarian And Fallopian Tube	25 (1.44%)
Skin Appendage Conditions	19 (1.09%)
Muscle	17 (.98%)
Obstetric And Gynecological Therape...	17 (.98%)
Allergic Conditions	15 (.86%)
Breast	15 (.86%)
Anxiety Disorders	13 (.75%)
Body Temperature Conditions	13 (.75%)
Vascular Hemorrhagic	12 (.69%)
Bacterial Infectious	11 (.63%)
Dental And Gingival Conditions	10 (.57%)
Seizures	10 (.57%)
Endocrine Investigations	9 (.52%)
Angiedema And Urticaria	8 (.46%)
Depressed Mood Disorders	8 (.46%)
Embolism And Thrombosis	8 (.46%)
Neonatal And Perinatal Conditions	8 (.46%)
Oral Soft Tissue Conditions	8 (.46%)
Mood Disorders	7 (.4%)
Musculoskeletal And Connective Tiss...	7 (.4%)
Physical Examination Topics	7 (.4%)
Reproductive Neoplasms Female Benig...	7 (.4%)
Urinary Tract Signs	7 (.4%)
Fungal Infectious	6 (.34%)
Medication Errors	6 (.34%)
Mental Impairment	6 (.34%)
Respiratory	6 (.34%)
Sexual Function And Fertility	6 (.34%)
Water, Electrolyte And Mineral	6 (.34%)
Cervix Disorders	5 (.29%)
Gallbladder	5 (.29%)
Hematological	5 (.29%)
Hepatic And Hepatobiliary	5 (.29%)
Peritoneal And Retroperitoneal Cond...	5 (.29%)
Central Nervous System Vascular	4 (.23%)
External Ear Disorders	4 (.23%)
Fetal Complications	4 (.23%)
Gastrointestinal Motility And Defec...	4 (.23%)
Gastrointestinal Therapeutic Proced...	4 (.23%)
Headaches	4 (.23%)
Joint	4 (.23%)
Lifestyle Issues	4 (.23%)
Movement Disorders	4 (.23%)
Vascular	4 (.23%)
Anemias Nonhemolytic And Marrow Dep...	3 (.17%)
Autoimmune	3 (.17%)
Bone And Joint Injuries	3 (.17%)
Maternal Complications Of Labour An...	3 (.17%)
Suicidal And Self-injurious Behavio...	3 (.17%)
Therapeutic Procedures And Supporti...	3 (.17%)
Vision	3 (.17%)
Appetite And General Nutritional	2 (.11%)
Deliria	2 (.11%)
Gastrointestinal Hemorrhages	2 (.11%)
Gastrointestinal Inflammatory Condi...	2 (.11%)
Gastrointestinal Tract Disorders Co...	2 (.11%)
Gastrointestinal Ulceration And Per...	2 (.11%)
Hematology Investigations	2 (.11%)
Musculoskeletal And Connective Tiss...	2 (.11%)
Neurological, Special Senses And Ps...	2 (.11%)
Placental, Amniotic And Cavity Diso...	2 (.11%)
Platelet	2 (.11%)
Renal And Urinary Tract Disorders C...	2 (.11%)
Renal And Urinary Tract Investigati...	2 (.11%)
Renal Disorders	2 (.11%)
Sexual Dysfunctions, Disturbances A...	2 (.11%)
White Blood Cell	2 (.11%)
Acid-base	1 (.06%)
Anal And Rectal Conditions	1 (.06%)
Bone And Joint Therapeutic Procedur...	1 (.06%)
Breast Neoplasms Malignant And Unsp...	1 (.06%)
Bronchial Disorders	1 (.06%)
Cardiac And Vascular Disorders Cong...	1 (.06%)
Cardiac And Vascular Investigations	1 (.06%)
Developmental	1 (.06%)
Eating Disorders	1 (.06%)
Electrolyte And Fluid Balance Condi...	1 (.06%)
Family Issues	1 (.06%)
Female Reproductive Tract Infection...	1 (.06%)
Fetal And Neonatal	1 (.06%)
Hearing	1 (.06%)
Hepatobiliary Therapeutic Procedure...	1 (.06%)
Inner Ear And Viiith Cranial Nerve	1 (.06%)
Investigations, Imaging And Histopa...	1 (.06%)
Lymphomas	1 (.06%)
Miscellaneous And Site Unspecified ...	1 (.06%)

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This graph shows the top categories of adverse events submitted to the FDA for Paragard T, 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 Paragard T 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.