ISOTRETINOIN

Isotretinoin Adverse Events Reported to the FDA Over Time

How are Isotretinoin adverse event reports trending over time?

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

Most Common Isotretinoin Adverse Events Reported to the FDA

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

Pregnancy	2312 (16.51%)
Drug Exposure During Pregnancy	611 (4.36%)
Abortion Induced	591 (4.22%)
No Adverse Event	399 (2.85%)
Depression	248 (1.77%)
Suicidal Ideation	234 (1.67%)
Abdominal Pain	228 (1.63%)
Rectal Haemorrhage	224 (1.6%)
Diarrhoea	204 (1.46%)
Abortion Spontaneous	198 (1.41%)
Inflammatory Bowel Disease	196 (1.4%)
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Treatment Noncompliance	147 (1.05%)
Frequent Bowel Movements	143 (1.02%)
Headache	127 (.91%)
Normal Newborn	113 (.81%)
Suicide Attempt	112 (.8%)
Nausea	98 (.7%)
Unintended Pregnancy	98 (.7%)
Arthralgia	85 (.61%)
Live Birth	84 (.6%)
Anxiety	81 (.58%)
Anaemia	72 (.51%)
Lip Dry	71 (.51%)
Dry Skin	69 (.49%)
Completed Suicide	67 (.48%)
Colitis Ulcerative	65 (.46%)
Surgery	63 (.45%)
Gastrointestinal Disorder	61 (.44%)
Epistaxis	60 (.43%)
Cheilitis	58 (.41%)
Dry Eye	55 (.39%)
Dyspnoea	54 (.39%)
Irritable Bowel Syndrome	54 (.39%)
Myalgia	54 (.39%)
Vomiting	54 (.39%)
Back Pain	52 (.37%)
Death	52 (.37%)
Fatigue	52 (.37%)
Acne	51 (.36%)
Colitis	49 (.35%)
Off Label Use	48 (.34%)
Vaginal Haemorrhage	46 (.33%)
Sinusitis	44 (.31%)
Drug Exposure Before Pregnancy	43 (.31%)
Staphylococcal Infection	42 (.3%)
Aggression	39 (.28%)
Asthenia	39 (.28%)
Ectopic Pregnancy	38 (.27%)
Convulsion	36 (.26%)
Malaise	36 (.26%)
Urinary Tract Infection	35 (.25%)
Sacroiliitis	34 (.24%)
Drug Interaction	33 (.24%)
Vision Blurred	33 (.24%)
Chest Pain	32 (.23%)
Dry Mouth	32 (.23%)
Hallucination	32 (.23%)
Weight Decreased	32 (.23%)
Dizziness	31 (.22%)
Nasal Vestibulitis	31 (.22%)
Alopecia	30 (.21%)
Condition Aggravated	30 (.21%)
Depressed Mood	30 (.21%)
Gastrooesophageal Reflux Disease	30 (.21%)
Jaundice	30 (.21%)
Pregnancy On Oral Contraceptive	30 (.21%)
Insomnia	29 (.21%)
Mood Altered	29 (.21%)
Mood Swings	29 (.21%)
Oedema	29 (.21%)
Pyrexia	28 (.2%)
Rash	28 (.2%)
Anger	27 (.19%)
Blood Triglycerides Increased	27 (.19%)
Drug Dose Omission	27 (.19%)
Bipolar Disorder	26 (.19%)
Congenital Anomaly	26 (.19%)
Haematochezia	26 (.19%)
Blindness	25 (.18%)
Erectile Dysfunction	25 (.18%)
Gait Disturbance	25 (.18%)
Hypercalcaemia	25 (.18%)
Road Traffic Accident	25 (.18%)
Drug Ineffective	24 (.17%)
Pregnancy With Contraceptive Device	24 (.17%)
Pyoderma Gangrenosum	24 (.17%)
Acne Fulminans	23 (.16%)
Cough	23 (.16%)
Joint Swelling	23 (.16%)
Medication Error	23 (.16%)
Pulmonary Embolism	23 (.16%)
Blood Cholesterol Increased	22 (.16%)
Ectopic Pregnancy Termination	22 (.16%)
Hyperhidrosis	22 (.16%)
Liver Function Test Abnormal	22 (.16%)
Pain	22 (.16%)
Pregnancy Of Partner	22 (.16%)
Sapho Syndrome	22 (.16%)
Intentional Overdose	21 (.15%)
Irritability	21 (.15%)
Amnesia	20 (.14%)

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

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

Pregnancy, Labour, Delivery And Pos...	2686 (19.18%)
Chemical Injury And Poisoning	674 (4.81%)
Obstetric And Gynecological Therape...	643 (4.59%)
Suicidal And Self-injurious Behavio...	462 (3.3%)
Gastrointestinal Motility And Defec...	457 (3.26%)
Gastrointestinal Signs	430 (3.07%)
Gastrointestinal Inflammatory Condi...	340 (2.43%)
Depressed Mood Disorders	327 (2.34%)
Epidermal And Dermal Conditions	282 (2.01%)
Infections - Pathogen Unspecified	266 (1.9%)
Gastrointestinal Hemorrhages	263 (1.88%)
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Abortions And Stillbirth	246 (1.76%)
Neurological	206 (1.47%)
Lifestyle Issues	181 (1.29%)
Skin Appendage Conditions	171 (1.22%)
Joint	161 (1.15%)
Headaches	159 (1.14%)
Anxiety Disorders	142 (1.01%)
Respiratory	138 (.99%)
Therapeutic Procedures And Supporti...	136 (.97%)
Medication Errors	128 (.91%)
Mood Disorders	121 (.86%)
Musculoskeletal And Connective Tiss...	118 (.84%)
Muscle	115 (.82%)
Oral Soft Tissue Conditions	111 (.79%)
Salivary Gland Conditions	104 (.74%)
Therapeutic And Nontherapeutic Effe...	100 (.71%)
Anemias Nonhemolytic And Marrow Dep...	98 (.7%)
Hepatobiliary	98 (.7%)
Vision	94 (.67%)
Bacterial Infectious	87 (.62%)
Injuries	87 (.62%)
Gastrointestinal Conditions	86 (.61%)
Hematology Investigations	85 (.61%)
Upper Respiratory Tract Disorders	83 (.59%)
Personality Disorders	79 (.56%)
Hepatic And Hepatobiliary	78 (.56%)
Disturbances In Thinking	77 (.55%)
Eye	77 (.55%)
Vulvovaginal Disorders	65 (.46%)
Maternal Complications Of Pregnancy	63 (.45%)
Bone Disorders	60 (.43%)
Mental Impairment	58 (.41%)
Viral Infectious	57 (.41%)
White Blood Cell	57 (.41%)
Fatal Outcomes	56 (.4%)
Sleep Disorders	56 (.4%)
Lipid Analyses	53 (.38%)
Physical Examination Topics	50 (.36%)
Seizures	48 (.34%)
Congenital And Hereditary	43 (.31%)
Miscellaneous And Site Unspecified ...	43 (.31%)
Endocrine Investigations	42 (.3%)
Vascular	40 (.29%)
Cardiac Arrhythmias	39 (.28%)
Movement Disorders	38 (.27%)
Skin And Subcutaneous Tissue	38 (.27%)
Schizophrenia And Other Psychotic	37 (.26%)
Appetite And General Nutritional	34 (.24%)
Cardiac And Vascular Disorders Cong...	34 (.24%)
Cardiac Disorder Signs	34 (.24%)
Head And Neck Therapeutic Procedure...	34 (.24%)
Manic And Bipolar Mood Disorders	34 (.24%)
Menstrual Cycle And Uterine Bleedin...	34 (.24%)
Bone And Joint Injuries	32 (.23%)
Nervous System Neoplasms Malignant ...	32 (.23%)
Body Temperature Conditions	31 (.22%)
Cornification And Dystrophic Skin	31 (.22%)
Protein And Chemistry Analyses	31 (.22%)
Sexual Function And Fertility	31 (.22%)
Bone, Calcium, Magnesium And Phosph...	29 (.21%)
Breast	29 (.21%)
Electrolyte And Fluid Balance Condi...	28 (.2%)
Tissue	28 (.2%)
Embolism And Thrombosis	27 (.19%)
Leukemias	27 (.19%)
Musculoskeletal And Connective Tiss...	27 (.19%)
Peripheral Neuropathies	27 (.19%)
Enzyme	26 (.19%)
Neurological Disorders Congenital	26 (.19%)
Psychiatric	26 (.19%)
Deliria	25 (.18%)
Ear And Labyrinthine Disorders Cong...	25 (.18%)
Nephropathies	25 (.18%)
Ocular Infections, Irritations And ...	25 (.18%)
Skin Vascular Abnormalities	25 (.18%)
Pulmonary Vascular	24 (.17%)
Central Nervous System Vascular	23 (.16%)
Family Issues	23 (.16%)
Glucose Metabolism Disorders	23 (.16%)
Hearing	23 (.16%)
Maternal Complications Of Labour An...	23 (.16%)
Urolithiases	22 (.16%)
Cranial Nerve Disorders	21 (.15%)
Platelet	21 (.15%)
Urinary Tract Signs	21 (.15%)
Encephalopathies	19 (.14%)
Exocrine Pancreas Conditions	19 (.14%)
Musculoskeletal And Connective Tiss...	19 (.14%)
Ovarian And Fallopian Tube	19 (.14%)
Procedural And Device Related Injur...	19 (.14%)

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