LEVONORGESTREL

Levonorgestrel Adverse Events Reported to the FDA Over Time

How are Levonorgestrel adverse event reports trending over time?

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

Most Common Levonorgestrel Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy	110 (2.94%)
Drug Ineffective	95 (2.54%)
Nausea	79 (2.11%)
Pregnancy On Oral Contraceptive	75 (2.01%)
Vomiting	65 (1.74%)
Abortion Spontaneous	64 (1.71%)
Unintended Pregnancy	62 (1.66%)
Drug Interaction	51 (1.36%)
Pulmonary Embolism	49 (1.31%)
Dizziness	43 (1.15%)
Headache	41 (1.1%)
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Metrorrhagia	39 (1.04%)
Pregnancy After Post Coital Contrac...	38 (1.02%)
Menstruation Irregular	37 (.99%)
Abdominal Pain Lower	35 (.94%)
Abdominal Pain	33 (.88%)
Amenorrhoea	30 (.8%)
Vaginal Haemorrhage	29 (.78%)
Loss Of Consciousness	28 (.75%)
Premature Baby	27 (.72%)
Fatigue	25 (.67%)
Urinary Tract Infection	25 (.67%)
Deep Vein Thrombosis	24 (.64%)
Ectopic Pregnancy	23 (.62%)
Inappropriate Schedule Of Drug Admi...	23 (.62%)
Abdominal Pain Upper	20 (.53%)
Abortion Induced	20 (.53%)
Breast Cancer Female	20 (.53%)
Caesarean Section	20 (.53%)
Dyspnoea	20 (.53%)
Haemorrhage	20 (.53%)
Thrombosis	20 (.53%)
Alanine Aminotransferase Increased	19 (.51%)
Cerebral Infarction	19 (.51%)
Menstruation Delayed	19 (.51%)
Anxiety	18 (.48%)
Chest Pain	18 (.48%)
Condition Aggravated	18 (.48%)
Menstrual Disorder	18 (.48%)
Vaginal Discharge	18 (.48%)
Cerebrovascular Accident	17 (.45%)
Breast Tenderness	16 (.43%)
Menorrhagia	16 (.43%)
Migraine	16 (.43%)
Pain	16 (.43%)
Aspartate Aminotransferase Increase...	15 (.4%)
Diarrhoea	15 (.4%)
Liver Disorder	15 (.4%)
Staphylococcal Sepsis	15 (.4%)
Suprapubic Pain	15 (.4%)
Depression	14 (.37%)
Device Dislocation	14 (.37%)
Hypotension	14 (.37%)
Antepartum Haemorrhage	13 (.35%)
Feeling Hot	13 (.35%)
Malaise	13 (.35%)
Oedema Peripheral	13 (.35%)
Syncope	13 (.35%)
Congenital Anomaly	12 (.32%)
Iud Migration	12 (.32%)
Muscle Spasms	12 (.32%)
Blood Bilirubin Increased	11 (.29%)
Blood Lactate Dehydrogenase Increas...	11 (.29%)
Genital Haemorrhage	11 (.29%)
Maternal Drugs Affecting Foetus	11 (.29%)
Myocardial Infarction	11 (.29%)
Palpitations	11 (.29%)
Abortion Threatened	10 (.27%)
Asthenia	10 (.27%)
Cholestasis	10 (.27%)
Cytolytic Hepatitis	10 (.27%)
Hyperhidrosis	10 (.27%)
Hypoaesthesia	10 (.27%)
Petit Mal Epilepsy	10 (.27%)
Pyrexia	10 (.27%)
Flatulence	9 (.24%)
Pain In Extremity	9 (.24%)
Paraesthesia	9 (.24%)
Pelvic Pain	9 (.24%)
Pregnancy	9 (.24%)
Pregnancy With Contraceptive Device	9 (.24%)
Sepsis	9 (.24%)
White Blood Cell Count Increased	9 (.24%)
Blindness Unilateral	8 (.21%)
Blood Pressure Increased	8 (.21%)
Convulsion	8 (.21%)
Cough	8 (.21%)
Dysmenorrhoea	8 (.21%)
Feeling Abnormal	8 (.21%)
Fibrin D Dimer Increased	8 (.21%)
Foetal Growth Retardation	8 (.21%)
Galactorrhoea	8 (.21%)
Hepatomegaly	8 (.21%)
Pruritus	8 (.21%)
Pulmonary Artery Thrombosis	8 (.21%)
Pulmonary Infarction	8 (.21%)
Suicide Attempt	8 (.21%)
Transient Ischaemic Attack	8 (.21%)
Vision Blurred	8 (.21%)
Abdominal Distension	7 (.19%)
Abortion	7 (.19%)

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

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

Gastrointestinal Signs	266 (7.11%)
Pregnancy, Labour, Delivery And Pos...	199 (5.32%)
Menstrual Cycle And Uterine Bleedin...	191 (5.11%)
Therapeutic And Nontherapeutic Effe...	160 (4.28%)
Neurological	138 (3.69%)
Chemical Injury And Poisoning	125 (3.34%)
Infections - Pathogen Unspecified	94 (2.51%)
Hepatic And Hepatobiliary	91 (2.43%)
Abortions And Stillbirth	89 (2.38%)
Central Nervous System Vascular	84 (2.25%)
Embolism And Thrombosis	80 (2.14%)
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Pulmonary Vascular	70 (1.87%)
Hematology Investigations	59 (1.58%)
Headaches	57 (1.52%)
Hepatobiliary	55 (1.47%)
Vulvovaginal Disorders	54 (1.44%)
Procedural And Device Related Injur...	50 (1.34%)
Medication Errors	47 (1.26%)
Maternal Complications Of Pregnancy	46 (1.23%)
Breast	45 (1.2%)
Respiratory	44 (1.18%)
Obstetric And Gynecological Therape...	42 (1.12%)
Epidermal And Dermal Conditions	39 (1.04%)
Cardiac And Vascular Investigations	35 (.94%)
Seizures	33 (.88%)
Neonatal And Perinatal Conditions	32 (.86%)
Vision	32 (.86%)
Bacterial Infectious	31 (.83%)
Skin Appendage Conditions	31 (.83%)
Anxiety Disorders	28 (.75%)
Breast Neoplasms Malignant And Unsp...	28 (.75%)
Cardiac Arrhythmias	27 (.72%)
Endocrine Investigations	26 (.7%)
Musculoskeletal And Connective Tiss...	26 (.7%)
Coronary Artery	24 (.64%)
Gastrointestinal Motility And Defec...	23 (.62%)
Physical Examination Topics	23 (.62%)
Vascular Hemorrhagic	23 (.62%)
Uterine, Pelvic And Broad Ligament	21 (.56%)
Depressed Mood Disorders	20 (.53%)
Reproductive Tract	20 (.53%)
Cardiac And Vascular Disorders Cong...	19 (.51%)
Congenital And Hereditary	19 (.51%)
Muscle	19 (.51%)
Enzyme	18 (.48%)
Movement Disorders	18 (.48%)
Musculoskeletal And Connective Tiss...	17 (.45%)
Reproductive Neoplasms Female Malig...	17 (.45%)
Suicidal And Self-injurious Behavio...	17 (.45%)
Eye	16 (.43%)
Retina, Choroid And Vitreous Hemorr...	16 (.43%)
Decreased And Nonspecific Blood Pre...	15 (.4%)
Mood Disorders	15 (.4%)
Ocular Structural Change, Deposit A...	15 (.4%)
Renal Disorders	15 (.4%)
Allergic Conditions	13 (.35%)
Cardiac Disorder Signs	13 (.35%)
Fetal Complications	13 (.35%)
Lifestyle Issues	13 (.35%)
Body Temperature Conditions	12 (.32%)
Gastrointestinal Tract Disorders Co...	12 (.32%)
Placental, Amniotic And Cavity Diso...	12 (.32%)
Angiedema And Urticaria	11 (.29%)
Appetite And General Nutritional	11 (.29%)
Immunology And Allergy	11 (.29%)
Ovarian And Fallopian Tube	11 (.29%)
Urinary Tract Signs	11 (.29%)
Electrolyte And Fluid Balance Condi...	10 (.27%)
Injuries	10 (.27%)
Myocardial	10 (.27%)
Ocular Infections, Irritations And ...	10 (.27%)
Personality Disorders	10 (.27%)
Vascular	10 (.27%)
Arteriosclerosis, Stenosis, Vascula...	9 (.24%)
Gastrointestinal Hemorrhages	9 (.24%)
Hearing	9 (.24%)
Hepatic And Biliary Neoplasms Benig...	9 (.24%)
Maternal Complications Of Labour An...	9 (.24%)
Peritoneal And Retroperitoneal Cond...	9 (.24%)
Coagulopathies And Bleeding Diathes...	8 (.21%)
Cranial Nerve Disorders	8 (.21%)
Gastrointestinal Vascular Condition...	8 (.21%)
Musculoskeletal And Connective Tiss...	8 (.21%)
Neurological Disorders Of The Eye	8 (.21%)
Reproductive Neoplasms Female Benig...	8 (.21%)
Heart Failures	7 (.19%)
Inner Ear And Viiith Cranial Nerve	7 (.19%)
Oral Soft Tissue Conditions	7 (.19%)
Viral Infectious	7 (.19%)
Abdominal Hernias And Other Abdomin...	6 (.16%)
Anemias Nonhemolytic And Marrow Dep...	6 (.16%)
Breast Neoplasms Benign	6 (.16%)
Deliria	6 (.16%)
Demyelinating	6 (.16%)
Exocrine Pancreas Conditions	6 (.16%)
Neonatal Respiratory	6 (.16%)
Pleural	6 (.16%)
Renal And Urinary Tract Disorders C...	6 (.16%)
Respiratory Disorders Congenital	6 (.16%)
Vascular Hypertensive	6 (.16%)
Bone And Joint Injuries	5 (.13%)

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