EPINEPHRINE

Epinephrine Adverse Events Reported to the FDA Over Time

How are Epinephrine adverse event reports trending over time?

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

Most Common Epinephrine Adverse Events Reported to the FDA

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

Hypotension	351 (1.41%)
Drug Ineffective	311 (1.25%)
Cardiac Arrest	285 (1.15%)
Convulsion	259 (1.04%)
Anaesthetic Complication	235 (.94%)
Dyspnoea	230 (.92%)
Product Quality Issue	225 (.9%)
Loss Of Consciousness	224 (.9%)
Chondrolysis	222 (.89%)
Dizziness	207 (.83%)
Pain	206 (.83%)
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Musculoskeletal Pain	189 (.76%)
Device Failure	188 (.76%)
Medication Error	188 (.76%)
Drug Toxicity	187 (.75%)
Bradycardia	177 (.71%)
Tachycardia	177 (.71%)
Nausea	175 (.7%)
Drug Exposure During Pregnancy	169 (.68%)
Drug Interaction	167 (.67%)
Overdose	161 (.65%)
Headache	159 (.64%)
Post Procedural Complication	159 (.64%)
Blood Pressure Decreased	145 (.58%)
Blood Pressure Increased	141 (.57%)
Incorrect Route Of Drug Administrat...	141 (.57%)
Hypoaesthesia	140 (.56%)
Hypertension	137 (.55%)
Anaphylactic Reaction	130 (.52%)
Vomiting	130 (.52%)
Ventricular Tachycardia	123 (.49%)
Grand Mal Convulsion	114 (.46%)
Oxygen Saturation Decreased	114 (.46%)
Anaphylactic Shock	113 (.45%)
Asthenia	110 (.44%)
Heart Rate Increased	110 (.44%)
Hypersensitivity	108 (.43%)
Drug Hypersensitivity	106 (.43%)
Joint Injury	106 (.43%)
Ventricular Fibrillation	106 (.43%)
Erythema	103 (.41%)
Activities Of Daily Living Impaired	101 (.41%)
Device Malfunction	101 (.41%)
Anxiety	98 (.39%)
Agitation	95 (.38%)
Coma	95 (.38%)
Confusional State	94 (.38%)
Paraesthesia	94 (.38%)
Respiratory Arrest	94 (.38%)
Visual Acuity Reduced	91 (.37%)
Wrong Technique In Drug Usage Proce...	90 (.36%)
Chest Pain	86 (.35%)
Muscular Weakness	86 (.35%)
Tremor	85 (.34%)
Pulmonary Oedema	84 (.34%)
Methaemoglobinaemia	83 (.33%)
Sinus Tachycardia	83 (.33%)
Palpitations	81 (.33%)
Unresponsive To Stimuli	81 (.33%)
Pain In Extremity	80 (.32%)
Off Label Use	79 (.32%)
Septic Arthritis Staphylococcal	79 (.32%)
Somnolence	78 (.31%)
Syncope	76 (.31%)
Cardio-respiratory Arrest	74 (.3%)
Procedural Complication	73 (.29%)
Wrong Drug Administered	73 (.29%)
Conjunctival Oedema	71 (.29%)
Pallor	71 (.29%)
Toxic Anterior Segment Syndrome	71 (.29%)
Musculoskeletal Disorder	70 (.28%)
Heart Rate Decreased	68 (.27%)
Hypoxia	68 (.27%)
Pyrexia	68 (.27%)
Urticaria	68 (.27%)
Arthralgia	67 (.27%)
Condition Aggravated	67 (.27%)
Oedema Peripheral	67 (.27%)
Restlessness	67 (.27%)
Cyanosis	66 (.27%)
Hypertensive Crisis	66 (.27%)
Musculoskeletal Discomfort	66 (.27%)
Stress Cardiomyopathy	66 (.27%)
Apnoea	65 (.26%)
Pruritus	65 (.26%)
Angioedema	64 (.26%)
Burning Sensation	64 (.26%)
Myocardial Infarction	64 (.26%)
Drug Administration Error	62 (.25%)
Incorrect Dose Administered	62 (.25%)
Parophthalmia	62 (.25%)
Death	61 (.25%)
Exophthalmos	61 (.25%)
Fall	61 (.25%)
Accidental Overdose	60 (.24%)
Injection Site Pain	60 (.24%)
Fatigue	59 (.24%)
Insomnia	59 (.24%)
Respiratory Failure	59 (.24%)
Bronchospasm	58 (.23%)
Vision Blurred	58 (.23%)

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

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

Neurological	1792 (7.2%)
Cardiac Arrhythmias	1489 (5.98%)
Procedural And Device Related Injur...	1212 (4.87%)
Medication Errors	1005 (4.04%)
Respiratory	923 (3.71%)
Cardiac And Vascular Investigations	884 (3.55%)
Therapeutic And Nontherapeutic Effe...	690 (2.77%)
Epidermal And Dermal Conditions	584 (2.35%)
Musculoskeletal And Connective Tiss...	575 (2.31%)
Gastrointestinal Signs	512 (2.06%)
Allergic Conditions	500 (2.01%)
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Decreased And Nonspecific Blood Pre...	484 (1.94%)
Infections - Pathogen Unspecified	472 (1.9%)
Seizures	437 (1.76%)
Chemical Injury And Poisoning	419 (1.68%)
Injuries	379 (1.52%)
Movement Disorders	377 (1.51%)
Joint	351 (1.41%)
Coronary Artery	334 (1.34%)
Muscle	333 (1.34%)
Vision	316 (1.27%)
Administration Site Reactions	300 (1.21%)
Product Quality Issues	284 (1.14%)
Ocular Infections, Irritations And ...	272 (1.09%)
Anxiety Disorders	261 (1.05%)
Bacterial Infectious	256 (1.03%)
Tendon, Ligament And Cartilage	252 (1.01%)
Metabolic, Nutritional And Blood Ga...	207 (.83%)
Vascular Hypertensive	205 (.82%)
Cardiac Disorder Signs	187 (.75%)
Lower Respiratory Tract Disorders	181 (.73%)
Deliria	177 (.71%)
Ocular Neuromuscular	176 (.71%)
Hematology Investigations	172 (.69%)
Headaches	169 (.68%)
Bronchial Disorders	166 (.67%)
Physical Examination Topics	155 (.62%)
Bone And Joint Injuries	153 (.61%)
Lifestyle Issues	153 (.61%)
Vascular	142 (.57%)
Spinal Cord And Nerve Root	138 (.55%)
Angiedema And Urticaria	137 (.55%)
Skin Appendage Conditions	127 (.51%)
Heart Failures	125 (.5%)
Upper Respiratory Tract Disorders	123 (.49%)
Oral Soft Tissue Conditions	122 (.49%)
Therapeutic Procedures And Supporti...	119 (.48%)
Ocular Structural Change, Deposit A...	114 (.46%)
Eye	111 (.45%)
Peripheral Neuropathies	110 (.44%)
Urinary Tract Signs	109 (.44%)
Myocardial	108 (.43%)
Psychiatric	108 (.43%)
Fatal Outcomes	102 (.41%)
Central Nervous System Vascular	100 (.4%)
Body Temperature Conditions	97 (.39%)
Neurological, Special Senses And Ps...	94 (.38%)
Sleep Disorders	93 (.37%)
Renal Disorders	92 (.37%)
Enzyme	89 (.36%)
Hematological	88 (.35%)
Neuromuscular	84 (.34%)
Gastrointestinal Motility And Defec...	82 (.33%)
Obstetric And Gynecological Therape...	81 (.33%)
Electrolyte And Fluid Balance Condi...	80 (.32%)
Bone Disorders	77 (.31%)
Cranial Nerve Disorders	73 (.29%)
Hepatobiliary	72 (.29%)
Changes In Physical Activity	71 (.29%)
Anterior Eye Structural Change, Dep...	68 (.27%)
Tissue	67 (.27%)
Retina, Choroid And Vitreous Hemorr...	66 (.27%)
Mental Impairment	63 (.25%)
Tongue Conditions	63 (.25%)
Arteriosclerosis, Stenosis, Vascula...	59 (.24%)
Hepatic And Hepatobiliary	55 (.22%)
Glucose Metabolism Disorders	51 (.2%)
Hearing	51 (.2%)
Water, Electrolyte And Mineral	51 (.2%)
Acid-base	49 (.2%)
Vascular Hemorrhagic	49 (.2%)
Mood Disorders	48 (.19%)
Head And Neck Therapeutic Procedure...	47 (.19%)
Depressed Mood Disorders	43 (.17%)
Disturbances In Thinking	42 (.17%)
Toxicology And Therapeutic Drug Mon...	42 (.17%)
Dental And Gingival Conditions	41 (.16%)
Suicidal And Self-injurious Behavio...	40 (.16%)
Immunology And Allergy	39 (.16%)
Synovial And Bursal	39 (.16%)
Bone And Joint Therapeutic Procedur...	38 (.15%)
Anemias Nonhemolytic And Marrow Dep...	37 (.15%)
Coagulopathies And Bleeding Diathes...	37 (.15%)
Gastrointestinal Inflammatory Condi...	36 (.14%)
Viral Infectious	36 (.14%)
White Blood Cell	34 (.14%)
Encephalopathies	33 (.13%)
Gastrointestinal Conditions	31 (.12%)
Musculoskeletal And Connective Tiss...	31 (.12%)
Skin Vascular Abnormalities	31 (.12%)
Embolism And Thrombosis	29 (.12%)

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