CYCLOBENZAPRINE

Cyclobenzaprine Adverse Events Reported to the FDA Over Time

How are Cyclobenzaprine adverse event reports trending over time?

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

Most Common Cyclobenzaprine Adverse Events Reported to the FDA

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

Completed Suicide	728 (7.51%)
Cardiac Arrest	301 (3.1%)
Respiratory Arrest	277 (2.86%)
Cardio-respiratory Arrest	199 (2.05%)
Drug Toxicity	167 (1.72%)
Death	129 (1.33%)
Overdose	119 (1.23%)
Multiple Drug Overdose	116 (1.2%)
Intentional Drug Misuse	115 (1.19%)
Somnolence	115 (1.19%)
Confusional State	106 (1.09%)
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Drug Abuse	97 (1%)
Convulsion	96 (.99%)
Multiple Drug Overdose Intentional	91 (.94%)
Drug Interaction	89 (.92%)
Vomiting	86 (.89%)
Poisoning	74 (.76%)
Hypotension	71 (.73%)
Loss Of Consciousness	70 (.72%)
Nausea	70 (.72%)
Tachycardia	70 (.72%)
Dizziness	69 (.71%)
Hallucination	69 (.71%)
Depression	63 (.65%)
Drug Ineffective	63 (.65%)
Headache	62 (.64%)
Heart Rate Increased	61 (.63%)
Pain	61 (.63%)
Suicide Attempt	60 (.62%)
Feeling Abnormal	58 (.6%)
Coma	55 (.57%)
Dyspnoea	54 (.56%)
Memory Impairment	51 (.53%)
Lethargy	49 (.51%)
Fall	48 (.5%)
Muscle Spasms	48 (.5%)
Unresponsive To Stimuli	46 (.47%)
Fatigue	45 (.46%)
Anxiety	43 (.44%)
Tremor	43 (.44%)
Intentional Overdose	42 (.43%)
Mental Status Changes	42 (.43%)
Amnesia	39 (.4%)
Delirium	39 (.4%)
Depressed Level Of Consciousness	39 (.4%)
Drug Exposure During Pregnancy	37 (.38%)
Insomnia	36 (.37%)
Agitation	35 (.36%)
Dysarthria	34 (.35%)
Hypertension	34 (.35%)
Suicidal Ideation	34 (.35%)
Asthenia	33 (.34%)
Aspartate Aminotransferase Increase...	31 (.32%)
Blood Pressure Increased	31 (.32%)
Drug Screen Positive	31 (.32%)
Malaise	30 (.31%)
Paranoia	30 (.31%)
Dry Mouth	29 (.3%)
Metabolic Acidosis	29 (.3%)
Disorientation	28 (.29%)
Aggression	27 (.28%)
Chest Pain	27 (.28%)
Constipation	27 (.28%)
Sedation	27 (.28%)
Alanine Aminotransferase Increased	26 (.27%)
Hypoaesthesia	26 (.27%)
Weight Increased	26 (.27%)
Aspiration	25 (.26%)
Back Pain	25 (.26%)
Dehydration	25 (.26%)
Hyperhidrosis	25 (.26%)
Intervertebral Disc Protrusion	24 (.25%)
Pneumonia	24 (.25%)
Vision Blurred	24 (.25%)
Weight Decreased	24 (.25%)
Abnormal Behaviour	23 (.24%)
Blood Creatine Phosphokinase Increa...	23 (.24%)
Gait Disturbance	23 (.24%)
Incorrect Dose Administered	23 (.24%)
Road Traffic Accident	23 (.24%)
Serotonin Syndrome	23 (.24%)
Urinary Retention	23 (.24%)
Pulmonary Oedema	22 (.23%)
Rhabdomyolysis	22 (.23%)
Sinus Tachycardia	22 (.23%)
Spina Bifida	22 (.23%)
Arrhythmia	21 (.22%)
Pain In Extremity	21 (.22%)
Respiratory Failure	20 (.21%)
Stress	20 (.21%)
Accidental Death	19 (.2%)
Nightmare	19 (.2%)
Sleep Disorder	19 (.2%)
Chest Discomfort	18 (.19%)
Renal Failure	18 (.19%)
Syncope	18 (.19%)
Urinary Incontinence	18 (.19%)
Wrong Technique In Drug Usage Proce...	18 (.19%)
Deafness	17 (.18%)
Delusion	17 (.18%)
Oedema Peripheral	17 (.18%)

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

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

Suicidal And Self-injurious Behavio...	845 (8.72%)
Neurological	717 (7.4%)
Cardiac Arrhythmias	678 (6.99%)
Medication Errors	533 (5.5%)
Respiratory	513 (5.29%)
Psychiatric	313 (3.23%)
Chemical Injury And Poisoning	302 (3.12%)
Therapeutic And Nontherapeutic Effe...	222 (2.29%)
Gastrointestinal Signs	217 (2.24%)
Cardiac And Vascular Investigations	179 (1.85%)
Deliria	173 (1.78%)
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Fatal Outcomes	162 (1.67%)
Injuries	145 (1.5%)
Muscle	145 (1.5%)
Mental Impairment	133 (1.37%)
Disturbances In Thinking	123 (1.27%)
Seizures	118 (1.22%)
Anxiety Disorders	117 (1.21%)
Sleep Disorders	107 (1.1%)
Physical Examination Topics	100 (1.03%)
Infections - Pathogen Unspecified	97 (1%)
Metabolic, Nutritional And Blood Ga...	96 (.99%)
Decreased And Nonspecific Blood Pre...	95 (.98%)
Musculoskeletal And Connective Tiss...	94 (.97%)
Hepatobiliary	87 (.9%)
Urinary Tract Signs	86 (.89%)
Hepatic And Hepatobiliary	85 (.88%)
Epidermal And Dermal Conditions	81 (.84%)
Movement Disorders	79 (.81%)
Headaches	74 (.76%)
Depressed Mood Disorders	72 (.74%)
Personality Disorders	72 (.74%)
Vision	71 (.73%)
Toxicology And Therapeutic Drug Mon...	69 (.71%)
Lifestyle Issues	63 (.65%)
Gastrointestinal Motility And Defec...	61 (.63%)
Neuromuscular	55 (.57%)
Lower Respiratory Tract Disorders	54 (.56%)
Renal Disorders	52 (.54%)
Allergic Conditions	48 (.5%)
Appetite And General Nutritional	46 (.47%)
Ocular Neuromuscular	46 (.47%)
Bone And Joint Injuries	45 (.46%)
Electrolyte And Fluid Balance Condi...	44 (.45%)
Water, Electrolyte And Mineral	43 (.44%)
Joint	42 (.43%)
Neurological Disorders Congenital	42 (.43%)
Skin Appendage Conditions	42 (.43%)
Enzyme	40 (.41%)
Vascular Hypertensive	40 (.41%)
Hematology Investigations	39 (.4%)
Musculoskeletal And Connective Tiss...	39 (.4%)
Mood Disorders	38 (.39%)
Acid-base	37 (.38%)
Cardiac Disorder Signs	36 (.37%)
Musculoskeletal And Connective Tiss...	33 (.34%)
Myocardial	32 (.33%)
Psychiatric And Behavioural Symptom...	32 (.33%)
Central Nervous System Vascular	31 (.32%)
Salivary Gland Conditions	29 (.3%)
Bronchial Disorders	27 (.28%)
Renal And Urinary Tract Investigati...	26 (.27%)
Body Temperature Conditions	24 (.25%)
Product Quality Issues	24 (.25%)
Coronary Artery	23 (.24%)
Therapeutic Procedures And Supporti...	23 (.24%)
Somatoform And Factitious	22 (.23%)
Changes In Physical Activity	21 (.22%)
Cranial Nerve Disorders	20 (.21%)
Encephalopathies	20 (.21%)
Gastrointestinal Conditions	20 (.21%)
Hearing	20 (.21%)
Obstetric And Gynecological Therape...	20 (.21%)
Vascular	20 (.21%)
Bacterial Infectious	19 (.2%)
Schizophrenia And Other Psychotic	19 (.2%)
Oral Soft Tissue Conditions	18 (.19%)
Viral Infectious	18 (.19%)
Inner Ear And Viiith Cranial Nerve	17 (.18%)
Pulmonary Vascular	17 (.18%)
Upper Respiratory Tract Disorders	17 (.18%)
Manic And Bipolar Mood Disorders	16 (.17%)
Pericardial	16 (.17%)
Spleen, Lymphatic And Reticulendoth...	16 (.17%)
Anemias Nonhemolytic And Marrow Dep...	15 (.15%)
Peripheral Neuropathies	15 (.15%)
Tongue Conditions	15 (.15%)
Demyelinating	14 (.14%)
Glaucoma And Ocular Hypertension	14 (.14%)
Increased Intracranial Pressure And...	14 (.14%)
Sexual Function And Fertility	14 (.14%)
Angiedema And Urticaria	13 (.13%)
Bone Disorders	13 (.13%)
Cardiac And Vascular Disorders Cong...	13 (.13%)
Cardiac Valve	13 (.13%)
Heart Failures	13 (.13%)
Maternal Complications Of Labour An...	13 (.13%)
Procedural And Device Related Injur...	13 (.13%)
Eye	12 (.12%)
Hematological	12 (.12%)
Investigations, Imaging And Histopa...	12 (.12%)

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