ROACCUTAN

Roaccutan Adverse Events Reported to the FDA Over Time

How are Roaccutan adverse event reports trending over time?

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

Most Common Roaccutan Adverse Events Reported to the FDA

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

Pregnancy	115 (9.52%)
No Adverse Event	68 (5.63%)
Drug Exposure During Pregnancy	45 (3.73%)
Abortion Induced	34 (2.81%)
Depression	31 (2.57%)
Suicidal Ideation	27 (2.24%)
Suicide Attempt	23 (1.9%)
Anxiety	22 (1.82%)
Completed Suicide	22 (1.82%)
Headache	16 (1.32%)
Normal Newborn	15 (1.24%)
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Pyrexia	12 (.99%)
Arthralgia	11 (.91%)
Dry Skin	11 (.91%)
Asthenia	9 (.75%)
Depressed Mood	9 (.75%)
Hallucination, Visual	9 (.75%)
Sleep Disorder	9 (.75%)
Hallucination, Auditory	8 (.66%)
Hyperhidrosis	8 (.66%)
Syncope	8 (.66%)
Alcohol Interaction	7 (.58%)
Blood Thyroid Stimulating Hormone I...	7 (.58%)
Decreased Appetite	7 (.58%)
Malaise	7 (.58%)
Panic Attack	7 (.58%)
Blood Cholesterol Increased	6 (.5%)
Bone Pain	6 (.5%)
Dizziness	6 (.5%)
Epistaxis	6 (.5%)
Fatigue	6 (.5%)
Gastrointestinal Motility Disorder	6 (.5%)
Nausea	6 (.5%)
Vertigo	6 (.5%)
Abnormal Behaviour	5 (.41%)
Balance Disorder	5 (.41%)
Colitis	5 (.41%)
Colitis Ulcerative	5 (.41%)
Convulsion	5 (.41%)
Drug Exposure Before Pregnancy	5 (.41%)
Eye Disorder	5 (.41%)
Hallucination	5 (.41%)
Lip Dry	5 (.41%)
Obsessive-compulsive Disorder	5 (.41%)
Psychotic Disorder	5 (.41%)
Abdominal Pain Upper	4 (.33%)
Amnesia	4 (.33%)
Blood Bilirubin Increased	4 (.33%)
Chest Discomfort	4 (.33%)
Chills	4 (.33%)
Daydreaming	4 (.33%)
Discomfort	4 (.33%)
Disturbance In Attention	4 (.33%)
Haematochezia	4 (.33%)
Mood Altered	4 (.33%)
Muscular Weakness	4 (.33%)
Musculoskeletal Pain	4 (.33%)
Myalgia	4 (.33%)
Nail Infection	4 (.33%)
Pain	4 (.33%)
Palpitations	4 (.33%)
Personality Change	4 (.33%)
Pharyngitis	4 (.33%)
Skin Ulcer	4 (.33%)
Tachycardia	4 (.33%)
Thrombophlebitis	4 (.33%)
Transaminases Increased	4 (.33%)
Tremor	4 (.33%)
Vomiting	4 (.33%)
Acne	3 (.25%)
Alopecia	3 (.25%)
Bladder Cancer	3 (.25%)
Calcinosis	3 (.25%)
Cerebral Infarction	3 (.25%)
Congenital Anomaly	3 (.25%)
Demyelination	3 (.25%)
Drug Interaction	3 (.25%)
Dry Eye	3 (.25%)
Dyspnoea	3 (.25%)
Enteritis	3 (.25%)
Eye Haemorrhage	3 (.25%)
Hepatic Neoplasm	3 (.25%)
Hyperthyroidism	3 (.25%)
Insomnia	3 (.25%)
Lower Gastrointestinal Haemorrhage	3 (.25%)
Lung Disorder	3 (.25%)
Metrorrhagia	3 (.25%)
Multiple Sclerosis	3 (.25%)
Muscle Spasms	3 (.25%)
Ovarian Cyst	3 (.25%)
Premature Baby	3 (.25%)
Proteinuria	3 (.25%)
Pulmonary Embolism	3 (.25%)
Pulmonary Oedema	3 (.25%)
Rash Macular	3 (.25%)
Sacroiliitis	3 (.25%)
Scar	3 (.25%)
Skin Disorder	3 (.25%)
Visual Field Defect	3 (.25%)
Abdominal Distension	2 (.17%)
Abortion Spontaneous	2 (.17%)

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

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

Pregnancy, Labour, Delivery And Pos...	133 (11.01%)
Suicidal And Self-injurious Behavio...	74 (6.13%)
Chemical Injury And Poisoning	55 (4.55%)
Depressed Mood Disorders	43 (3.56%)
Anxiety Disorders	40 (3.31%)
Epidermal And Dermal Conditions	35 (2.9%)
Obstetric And Gynecological Therape...	35 (2.9%)
Neurological	32 (2.65%)
Disturbances In Thinking	24 (1.99%)
Gastrointestinal Signs	19 (1.57%)
Joint	19 (1.57%)
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Headaches	18 (1.49%)
Skin Appendage Conditions	18 (1.49%)
Bone Disorders	17 (1.41%)
Infections - Pathogen Unspecified	17 (1.41%)
Body Temperature Conditions	13 (1.08%)
Gastrointestinal Inflammatory Condi...	13 (1.08%)
Hepatobiliary	13 (1.08%)
Muscle	13 (1.08%)
Sleep Disorders	13 (1.08%)
Therapeutic And Nontherapeutic Effe...	12 (.99%)
Gastrointestinal Motility And Defec...	11 (.91%)
Hematology Investigations	11 (.91%)
Mental Impairment	11 (.91%)
Hearing	10 (.83%)
Mood Disorders	10 (.83%)
Musculoskeletal And Connective Tiss...	10 (.83%)
Personality Disorders	10 (.83%)
Urinary Tract Signs	10 (.83%)
Appetite And General Nutritional	9 (.75%)
Eye	9 (.75%)
Schizophrenia And Other Psychotic	9 (.75%)
Cornification And Dystrophic Skin	8 (.66%)
Gastrointestinal Hemorrhages	8 (.66%)
Inner Ear And Viiith Cranial Nerve	8 (.66%)
Lipid Analyses	8 (.66%)
Psychiatric And Behavioural Symptom...	8 (.66%)
Seizures	8 (.66%)
Cardiac Arrhythmias	7 (.58%)
Endocrine Investigations	7 (.58%)
Hepatic And Hepatobiliary	7 (.58%)
Respiratory	7 (.58%)
Cognitive And Attention Disorders	6 (.5%)
Demyelinating	6 (.5%)
Dental And Gingival Conditions	6 (.5%)
Ocular Infections, Irritations And ...	6 (.5%)
Skin And Subcutaneous Tissue	6 (.5%)
Upper Respiratory Tract Disorders	6 (.5%)
Embolism And Thrombosis	5 (.41%)
Injuries	5 (.41%)
Menstrual Cycle And Uterine Bleedin...	5 (.41%)
Movement Disorders	5 (.41%)
Neurological Disorders Of The Eye	5 (.41%)
Salivary Gland Conditions	5 (.41%)
Thyroid Gland	5 (.41%)
Tissue	5 (.41%)
White Blood Cell	5 (.41%)
Cardiac Disorder Signs	4 (.33%)
Central Nervous System Vascular	4 (.33%)
Cranial Nerve Disorders	4 (.33%)
Gastrointestinal	4 (.33%)
Musculoskeletal And Connective Tiss...	4 (.33%)
Peripheral Neuropathies	4 (.33%)
Renal And Urinary Tract Neoplasms M...	4 (.33%)
Respiratory And Mediastinal Neoplas...	4 (.33%)
Tendon, Ligament And Cartilage	4 (.33%)
Abortions And Stillbirth	3 (.25%)
Bacterial Infectious	3 (.25%)
Breast	3 (.25%)
Congenital And Hereditary	3 (.25%)
Connective Tissue Disorders	3 (.25%)
Cutaneous Neoplasms Benign	3 (.25%)
Hepatobiliary Neoplasms Malignant A...	3 (.25%)
Increased Intracranial Pressure And...	3 (.25%)
Lower Respiratory Tract Disorders	3 (.25%)
Maternal Complications Of Pregnancy	3 (.25%)
Neonatal And Perinatal Conditions	3 (.25%)
Ocular Hemorrhages And Vascular	3 (.25%)
Ovarian And Fallopian Tube	3 (.25%)
Pleural	3 (.25%)
Procedural And Device Related Injur...	3 (.25%)
Pulmonary Vascular	3 (.25%)
Skin Vascular Abnormalities	3 (.25%)
Spinal Cord And Nerve Root	3 (.25%)
Viral Infectious	3 (.25%)
Vision	3 (.25%)
Adrenal Gland	2 (.17%)
Anemias Nonhemolytic And Marrow Dep...	2 (.17%)
Arteriosclerosis, Stenosis, Vascula...	2 (.17%)
Breast Neoplasms Malignant And Unsp...	2 (.17%)
Bronchial Disorders	2 (.17%)
Changes In Physical Activity	2 (.17%)
Deliria	2 (.17%)
Diabetic Complications	2 (.17%)
Enzyme	2 (.17%)
Glucose Metabolism Disorders	2 (.17%)
Head And Neck Therapeutic Procedure...	2 (.17%)
Immune	2 (.17%)
Maternal Complications Of Labour An...	2 (.17%)
Medication Errors	2 (.17%)
Metabolic, Nutritional And Blood Ga...	2 (.17%)

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