NITRAZEPAM

Nitrazepam Adverse Events Reported to the FDA Over Time

How are Nitrazepam adverse event reports trending over time?

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

Most Common Nitrazepam Adverse Events Reported to the FDA

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

Suicide Attempt	52 (3.5%)
Overdose	42 (2.83%)
Pneumonia Aspiration	34 (2.29%)
Coma	30 (2.02%)
Intentional Overdose	26 (1.75%)
Multiple Drug Overdose Intentional	23 (1.55%)
Drug Exposure During Pregnancy	21 (1.41%)
Drug Toxicity	21 (1.41%)
Respiratory Failure	18 (1.21%)
Depressed Level Of Consciousness	17 (1.14%)
Drug Rash With Eosinophilia And Sys...	15 (1.01%)
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Multiple Drug Overdose	14 (.94%)
Respiratory Arrest	14 (.94%)
Vomiting	14 (.94%)
Hallucination, Visual	13 (.87%)
Convulsion	12 (.81%)
Confusional State	11 (.74%)
Loss Of Consciousness	11 (.74%)
Myoclonus	11 (.74%)
Pneumonia	11 (.74%)
Pyrexia	11 (.74%)
C-reactive Protein Increased	10 (.67%)
Dizziness	10 (.67%)
Drug Interaction	10 (.67%)
Fall	10 (.67%)
Gait Disturbance	10 (.67%)
Tremor	10 (.67%)
Cardiac Disorder	9 (.61%)
Electrocardiogram Qt Prolonged	9 (.61%)
Fatigue	9 (.61%)
Hyperhidrosis	9 (.61%)
Lower Respiratory Tract Infection	9 (.61%)
Somnolence	9 (.61%)
Ventricular Tachycardia	9 (.61%)
Caesarean Section	8 (.54%)
Cardio-respiratory Arrest	8 (.54%)
Condition Aggravated	8 (.54%)
Neutrophil Count Increased	8 (.54%)
White Blood Cell Count Increased	8 (.54%)
Congenital Tricuspid Valve Stenosis	7 (.47%)
Grand Mal Convulsion	7 (.47%)
Hypoplastic Right Heart Syndrome	7 (.47%)
Psychotic Disorder	7 (.47%)
Altered State Of Consciousness	6 (.4%)
Arrhythmia	6 (.4%)
Blood Creatinine Increased	6 (.4%)
Cardiac Failure	6 (.4%)
Congenital Tricuspid Valve Atresia	6 (.4%)
Constipation	6 (.4%)
Delirium	6 (.4%)
Developmental Delay	6 (.4%)
Foetal Alcohol Syndrome	6 (.4%)
Hypertension	6 (.4%)
Hypotension	6 (.4%)
Maternal Drugs Affecting Foetus	6 (.4%)
Microcephaly	6 (.4%)
Rhabdomyolysis	6 (.4%)
Serotonin Syndrome	6 (.4%)
Anorexia	5 (.34%)
Blood Creatine Phosphokinase Increa...	5 (.34%)
Depression	5 (.34%)
Disorientation	5 (.34%)
Dyskinesia	5 (.34%)
Dyslalia	5 (.34%)
Dyspnoea	5 (.34%)
Insomnia	5 (.34%)
Irritability	5 (.34%)
Nausea	5 (.34%)
Renal Impairment	5 (.34%)
Respiratory Depression	5 (.34%)
Visual Impairment	5 (.34%)
Blood Urea Increased	4 (.27%)
Bradycardia	4 (.27%)
Cardiac Arrest	4 (.27%)
Chronic Obstructive Pulmonary Disea...	4 (.27%)
Death	4 (.27%)
Drug Abuse	4 (.27%)
Drug Hypersensitivity	4 (.27%)
Drug Withdrawal Syndrome	4 (.27%)
Drug Withdrawal Syndrome Neonatal	4 (.27%)
Emphysema	4 (.27%)
Human Herpes Virus 6 Serology Posit...	4 (.27%)
Hyponatraemia	4 (.27%)
Ileus Paralytic	4 (.27%)
Lymphocyte Stimulation Test Positiv...	4 (.27%)
Miosis	4 (.27%)
Myocardial Infarction	4 (.27%)
Neuroleptic Malignant Syndrome	4 (.27%)
Oedema Peripheral	4 (.27%)
Optic Nerve Hypoplasia	4 (.27%)
Pruritus	4 (.27%)
Pulmonary Embolism	4 (.27%)
Pulmonary Oedema	4 (.27%)
Shock	4 (.27%)
Stevens-johnson Syndrome	4 (.27%)
Suicidal Ideation	4 (.27%)
Syncope	4 (.27%)
Thirst	4 (.27%)
Agitation	3 (.2%)
Alanine Aminotransferase Increased	3 (.2%)
Anaemia	3 (.2%)

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

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

Neurological	130 (8.75%)
Medication Errors	115 (7.74%)
Respiratory	65 (4.37%)
Suicidal And Self-injurious Behavio...	62 (4.17%)
Chemical Injury And Poisoning	57 (3.84%)
Epidermal And Dermal Conditions	56 (3.77%)
Cardiac Arrhythmias	53 (3.57%)
Lower Respiratory Tract Disorders	44 (2.96%)
Infections - Pathogen Unspecified	43 (2.89%)
Hematology Investigations	32 (2.15%)
Gastrointestinal Signs	28 (1.88%)
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Movement Disorders	27 (1.82%)
Cardiac And Vascular Investigations	26 (1.75%)
Seizures	24 (1.62%)
Therapeutic And Nontherapeutic Effe...	24 (1.62%)
Deliria	22 (1.48%)
Hepatic And Hepatobiliary	22 (1.48%)
Cardiac And Vascular Disorders Cong...	21 (1.41%)
Disturbances In Thinking	20 (1.35%)
Renal And Urinary Tract Investigati...	18 (1.21%)
Renal Disorders	16 (1.08%)
Appetite And General Nutritional	15 (1.01%)
Muscle	15 (1.01%)
Decreased And Nonspecific Blood Pre...	14 (.94%)
Injuries	14 (.94%)
Body Temperature Conditions	13 (.87%)
Neuromuscular	13 (.87%)
Anxiety Disorders	12 (.81%)
Cardiac Disorder Signs	12 (.81%)
Gastrointestinal Motility And Defec...	12 (.81%)
Electrolyte And Fluid Balance Condi...	11 (.74%)
Heart Failures	10 (.67%)
Protein And Chemistry Analyses	10 (.67%)
Schizophrenia And Other Psychotic	10 (.67%)
Allergic Conditions	9 (.61%)
Anemias Nonhemolytic And Marrow Dep...	9 (.61%)
Hepatobiliary	9 (.61%)
Metabolic, Nutritional And Blood Ga...	9 (.61%)
Ocular Neuromuscular	9 (.61%)
Psychiatric	9 (.61%)
Skin Appendage Conditions	9 (.61%)
Congenital And Hereditary	8 (.54%)
Enzyme	8 (.54%)
Lifestyle Issues	8 (.54%)
Musculoskeletal And Connective Tiss...	8 (.54%)
Obstetric And Gynecological Therape...	8 (.54%)
Vision	8 (.54%)
Bacterial Infectious	7 (.47%)
Coronary Artery	7 (.47%)
Depressed Mood Disorders	7 (.47%)
Fatal Outcomes	7 (.47%)
Physical Examination Topics	7 (.47%)
Water, Electrolyte And Mineral	7 (.47%)
Microbiology And Serology	6 (.4%)
Neonatal Respiratory	6 (.4%)
Ocular Infections, Irritations And ...	6 (.4%)
Sleep Disorders	6 (.4%)
Vascular Hypertensive	6 (.4%)
Changes In Physical Activity	5 (.34%)
Encephalopathies	5 (.34%)
Gastrointestinal Tract Disorders Co...	5 (.34%)
Hypothalamus And Pituitary Gland	5 (.34%)
Mental Impairment	5 (.34%)
Acid-base	4 (.27%)
Bone And Joint Injuries	4 (.27%)
Bronchial Disorders	4 (.27%)
Eye Disorders Congenital	4 (.27%)
Hematological And Lymphoid Tissue T...	4 (.27%)
Musculoskeletal And Connective Tiss...	4 (.27%)
Neonatal And Perinatal Conditions	4 (.27%)
Oral Soft Tissue Conditions	4 (.27%)
Placental, Amniotic And Cavity Diso...	4 (.27%)
Pleural	4 (.27%)
Pulmonary Vascular	4 (.27%)
Toxicology And Therapeutic Drug Mon...	4 (.27%)
Anterior Eye Structural Change, Dep...	3 (.2%)
Communication Disorders	3 (.2%)
Gallbladder	3 (.2%)
Legal Issues	3 (.2%)
Menstrual Cycle And Uterine Bleedin...	3 (.2%)
Mood Disorders	3 (.2%)
Myocardial	3 (.2%)
Neurological Disorders Congenital	3 (.2%)
Psychiatric And Behavioural Symptom...	3 (.2%)
Skin	3 (.2%)
Spinal Cord And Nerve Root	3 (.2%)
Upper Respiratory Tract Disorders	3 (.2%)
Vascular	3 (.2%)
Cardiac Valve	2 (.13%)
Coagulopathies And Bleeding Diathes...	2 (.13%)
Dental And Gingival Conditions	2 (.13%)
Gastrointestinal Conditions	2 (.13%)
Gastrointestinal Stenosis And Obstr...	2 (.13%)
Miscellaneous And Site Unspecified ...	2 (.13%)
Pericardial	2 (.13%)
Personality Disorders	2 (.13%)
Pregnancy, Labour, Delivery And Pos...	2 (.13%)
Procedural And Device Related Injur...	2 (.13%)
Respiratory Disorders Congenital	2 (.13%)
Retina, Choroid And Vitreous Hemorr...	2 (.13%)
Salivary Gland Conditions	2 (.13%)

Share/Embed Graph Export Data

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