FENTANYL

Fentanyl Adverse Events Reported to the FDA Over Time

How are Fentanyl adverse event reports trending over time?

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

Most Common Fentanyl Adverse Events Reported to the FDA

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

Wrong Technique In Drug Usage Proce...	9721 (5.32%)
Product Quality Issue	5240 (2.87%)
Drug Ineffective	4677 (2.56%)
Pain	3586 (1.96%)
Inappropriate Schedule Of Drug Admi...	3184 (1.74%)
Nausea	2897 (1.59%)
Vomiting	2309 (1.26%)
Withdrawal Syndrome	2219 (1.21%)
Overdose	2211 (1.21%)
Somnolence	2184 (1.2%)
Hyperhidrosis	2140 (1.17%)
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Drug Administered At Inappropriate ...	1944 (1.06%)
Drug Prescribing Error	1879 (1.03%)
Dizziness	1674 (.92%)
Drug Effect Decreased	1593 (.87%)
Dyspnoea	1549 (.85%)
Inadequate Analgesia	1520 (.83%)
Fall	1388 (.76%)
Death	1360 (.74%)
Feeling Abnormal	1359 (.74%)
Drug Withdrawal Syndrome	1318 (.72%)
Malaise	1316 (.72%)
Insomnia	1303 (.71%)
Drug Toxicity	1283 (.7%)
Drug Dose Omission	1276 (.7%)
Confusional State	1251 (.68%)
Weight Decreased	1227 (.67%)
Incorrect Drug Administration Durat...	1178 (.64%)
Headache	1176 (.64%)
Loss Of Consciousness	1166 (.64%)
Treatment Noncompliance	1120 (.61%)
Depression	1080 (.59%)
Therapeutic Response Decreased	1076 (.59%)
Anxiety	1036 (.57%)
Constipation	998 (.55%)
Back Pain	992 (.54%)
Fatigue	982 (.54%)
Tremor	915 (.5%)
Hypertension	903 (.49%)
Drug Interaction	896 (.49%)
Application Site Erythema	894 (.49%)
Intentional Drug Misuse	838 (.46%)
Application Site Pruritus	837 (.46%)
Medication Error	819 (.45%)
Application Site Rash	807 (.44%)
Asthenia	805 (.44%)
Convulsion	778 (.43%)
Respiratory Arrest	744 (.41%)
Pneumonia	723 (.4%)
Hypotension	720 (.39%)
Drug Administration Error	714 (.39%)
Muscle Spasms	676 (.37%)
Cardiac Arrest	646 (.35%)
Coma	646 (.35%)
Diarrhoea	637 (.35%)
Incorrect Dose Administered	631 (.35%)
Respiratory Depression	626 (.34%)
Pain In Extremity	603 (.33%)
Pruritus	592 (.32%)
Breakthrough Pain	585 (.32%)
Application Site Irritation	579 (.32%)
Chest Pain	579 (.32%)
Pyrexia	563 (.31%)
Hallucination	556 (.3%)
Dehydration	545 (.3%)
Application Site Reaction	527 (.29%)
Amnesia	495 (.27%)
Depressed Level Of Consciousness	473 (.26%)
Weight Increased	469 (.26%)
Agitation	467 (.26%)
Drug Effect Increased	463 (.25%)
Cardio-respiratory Arrest	456 (.25%)
Delirium	456 (.25%)
Oedema Peripheral	456 (.25%)
Disorientation	450 (.25%)
Rash	444 (.24%)
Unresponsive To Stimuli	444 (.24%)
Off Label Use	434 (.24%)
Abdominal Pain	432 (.24%)
Arthralgia	431 (.24%)
Dermatitis Contact	431 (.24%)
Chills	427 (.23%)
Completed Suicide	426 (.23%)
Decreased Appetite	425 (.23%)
Sedation	422 (.23%)
Lethargy	413 (.23%)
Blood Pressure Increased	409 (.22%)
Cerebrovascular Accident	405 (.22%)
Accidental Overdose	400 (.22%)
Hospitalisation	399 (.22%)
Device Leakage	397 (.22%)
Condition Aggravated	395 (.22%)
Myocardial Infarction	395 (.22%)
Hypersomnia	382 (.21%)
Gait Disturbance	377 (.21%)
Suicidal Ideation	376 (.21%)
Road Traffic Accident	368 (.2%)
Nervousness	364 (.2%)
Narcotic Intoxication	361 (.2%)
Blood Cholesterol Increased	357 (.2%)
Drug Abuse	356 (.19%)

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

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

Medication Errors	25975 (14.22%)
Therapeutic And Nontherapeutic Effe...	11467 (6.28%)
Neurological	11433 (6.26%)
Gastrointestinal Signs	6997 (3.83%)
Respiratory	5783 (3.17%)
Administration Site Reactions	5774 (3.16%)
Product Quality Issues	5699 (3.12%)
Psychiatric	4292 (2.35%)
Epidermal And Dermal Conditions	3307 (1.81%)
Procedural And Device Related Injur...	3206 (1.75%)
Injuries	3084 (1.69%)
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Infections - Pathogen Unspecified	2818 (1.54%)
Skin Appendage Conditions	2801 (1.53%)
Cardiac Arrhythmias	2456 (1.34%)
Musculoskeletal And Connective Tiss...	2420 (1.32%)
Physical Examination Topics	2402 (1.31%)
Anxiety Disorders	2392 (1.31%)
Chemical Injury And Poisoning	2236 (1.22%)
Deliria	2174 (1.19%)
Lifestyle Issues	2153 (1.18%)
Gastrointestinal Motility And Defec...	2040 (1.12%)
Movement Disorders	1823 (1%)
Muscle	1758 (.96%)
Cardiac And Vascular Investigations	1726 (.94%)
Sleep Disorders	1721 (.94%)
Fatal Outcomes	1603 (.88%)
Therapeutic Procedures And Supporti...	1511 (.83%)
Headaches	1489 (.82%)
Mental Impairment	1480 (.81%)
Joint	1380 (.76%)
Appetite And General Nutritional	1325 (.73%)
Depressed Mood Disorders	1285 (.7%)
Bone And Joint Injuries	1253 (.69%)
Disturbances In Thinking	1053 (.58%)
Suicidal And Self-injurious Behavio...	1029 (.56%)
Seizures	1003 (.55%)
Decreased And Nonspecific Blood Pre...	975 (.53%)
Electrolyte And Fluid Balance Condi...	951 (.52%)
Vascular Hypertensive	932 (.51%)
Renal Disorders	829 (.45%)
Lower Respiratory Tract Disorders	825 (.45%)
Central Nervous System Vascular	790 (.43%)
Cardiac Disorder Signs	787 (.43%)
Coronary Artery	787 (.43%)
Metabolic, Nutritional And Blood Ga...	766 (.42%)
Musculoskeletal And Connective Tiss...	710 (.39%)
Allergic Conditions	702 (.38%)
Urinary Tract Signs	702 (.38%)
Hematology Investigations	655 (.36%)
Body Temperature Conditions	653 (.36%)
Miscellaneous And Site Unspecified ...	653 (.36%)
Mood Disorders	650 (.36%)
Vision	616 (.34%)
Toxicology And Therapeutic Drug Mon...	614 (.34%)
Bacterial Infectious	586 (.32%)
Vascular	566 (.31%)
Hepatic And Hepatobiliary	553 (.3%)
Bone Disorders	536 (.29%)
Ocular Neuromuscular	515 (.28%)
Hepatobiliary	504 (.28%)
Glucose Metabolism Disorders	493 (.27%)
Bronchial Disorders	491 (.27%)
Sleep Disturbances	441 (.24%)
Neuromuscular	425 (.23%)
Lipid Analyses	413 (.23%)
Gastrointestinal Conditions	402 (.22%)
Personality Disorders	398 (.22%)
Water, Electrolyte And Mineral	383 (.21%)
Dental And Gingival Conditions	375 (.21%)
Anemias Nonhemolytic And Marrow Dep...	351 (.19%)
Changes In Physical Activity	347 (.19%)
Peripheral Neuropathies	344 (.19%)
Heart Failures	340 (.19%)
Viral Infectious	339 (.19%)
Gastrointestinal Stenosis And Obstr...	337 (.18%)
Gastrointestinal Hemorrhages	330 (.18%)
Salivary Gland Conditions	307 (.17%)
Thyroid Gland	304 (.17%)
Psychiatric And Behavioural Symptom...	287 (.16%)
Renal And Urinary Tract Investigati...	286 (.16%)
Oral Soft Tissue Conditions	273 (.15%)
Upper Respiratory Tract Disorders	273 (.15%)
Myocardial	269 (.15%)
Gastrointestinal Neoplasms Malignan...	248 (.14%)
Exocrine Pancreas Conditions	234 (.13%)
Arteriosclerosis, Stenosis, Vascula...	233 (.13%)
Embolism And Thrombosis	231 (.13%)
Respiratory And Mediastinal Neoplas...	227 (.12%)
Enzyme	225 (.12%)
Encephalopathies	221 (.12%)
Bone And Joint Therapeutic Procedur...	218 (.12%)
Eating Disorders	218 (.12%)
Tissue	218 (.12%)
Inner Ear And Viiith Cranial Nerve	208 (.11%)
Legal Issues	201 (.11%)
Gallbladder	199 (.11%)
Pulmonary Vascular	193 (.11%)
Angiedema And Urticaria	192 (.11%)
Gastrointestinal Ulceration And Per...	183 (.1%)
Communication Disorders	170 (.09%)
Eye	165 (.09%)

Share/Embed Graph Export Data

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