DIPHENHYDRAMINE

Diphenhydramine Adverse Events Reported to the FDA Over Time

How are Diphenhydramine adverse event reports trending over time?

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

Most Common Diphenhydramine Adverse Events Reported to the FDA

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

Completed Suicide	1365 (9.01%)
Drug Toxicity	548 (3.62%)
Cardiac Arrest	430 (2.84%)
Cardio-respiratory Arrest	397 (2.62%)
Respiratory Arrest	388 (2.56%)
Death	384 (2.53%)
Overdose	253 (1.67%)
Intentional Drug Misuse	211 (1.39%)
Intentional Overdose	206 (1.36%)
Somnolence	157 (1.04%)
Vomiting	152 (1%)
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Multiple Drug Overdose	146 (.96%)
Drug Abuse	144 (.95%)
Poisoning	141 (.93%)
Convulsion	129 (.85%)
Loss Of Consciousness	128 (.84%)
Multiple Drug Overdose Intentional	127 (.84%)
Suicide Attempt	124 (.82%)
Hypotension	122 (.81%)
Tachycardia	105 (.69%)
Nausea	100 (.66%)
Dizziness	96 (.63%)
Drug Ineffective	93 (.61%)
Insomnia	89 (.59%)
Agitation	88 (.58%)
Dyspnoea	87 (.57%)
Coma	86 (.57%)
Unresponsive To Stimuli	78 (.51%)
Incorrect Dose Administered	76 (.5%)
Heart Rate Increased	74 (.49%)
Confusional State	69 (.46%)
Accidental Overdose	68 (.45%)
Pulmonary Oedema	67 (.44%)
Pruritus	65 (.43%)
Diarrhoea	64 (.42%)
Rhabdomyolysis	63 (.42%)
Drug Interaction	62 (.41%)
Hypersensitivity	62 (.41%)
Medication Error	61 (.4%)
Fall	60 (.4%)
Mydriasis	60 (.4%)
Delirium	59 (.39%)
Aspartate Aminotransferase Increase...	58 (.38%)
Tremor	58 (.38%)
Alanine Aminotransferase Increased	55 (.36%)
Hallucination	55 (.36%)
Headache	50 (.33%)
Fatigue	49 (.32%)
International Normalised Ratio Incr...	49 (.32%)
Hypertension	48 (.32%)
Drug Dependence	47 (.31%)
Hepatic Failure	47 (.31%)
Rash	47 (.31%)
Feeling Abnormal	46 (.3%)
Lethargy	46 (.3%)
Asthenia	44 (.29%)
Anxiety	43 (.28%)
Blood Creatine Phosphokinase Increa...	43 (.28%)
Blood Pressure Decreased	43 (.28%)
Pyrexia	43 (.28%)
Sinus Tachycardia	43 (.28%)
Urticaria	43 (.28%)
Off Label Use	42 (.28%)
Mental Status Changes	41 (.27%)
Drug Screen Positive	40 (.26%)
Brain Oedema	39 (.26%)
Condition Aggravated	39 (.26%)
Depressed Level Of Consciousness	39 (.26%)
Electrocardiogram Qt Prolonged	39 (.26%)
Blood Pressure Increased	38 (.25%)
Grand Mal Convulsion	38 (.25%)
Hyperhidrosis	38 (.25%)
Metabolic Acidosis	38 (.25%)
Product Quality Issue	38 (.25%)
Abdominal Pain Upper	36 (.24%)
Depression	36 (.24%)
Amnesia	34 (.22%)
Drug Abuser	34 (.22%)
Pain	34 (.22%)
Accident	33 (.22%)
Accidental Drug Intake By Child	33 (.22%)
Chest Pain	33 (.22%)
Hepatic Necrosis	33 (.22%)
Multi-organ Failure	33 (.22%)
Pulmonary Congestion	33 (.22%)
Blood Glucose Increased	32 (.21%)
Contusion	32 (.21%)
Electrocardiogram Qrs Complex Prolo...	31 (.2%)
Accidental Death	30 (.2%)
Cough	30 (.2%)
Disorientation	30 (.2%)
Drug Administration Error	30 (.2%)
Ventricular Tachycardia	30 (.2%)
Abnormal Behaviour	29 (.19%)
Accidental Exposure	29 (.19%)
Dehydration	29 (.19%)
Throat Tightness	29 (.19%)
Flushing	28 (.18%)
Syncope	28 (.18%)
Aggression	27 (.18%)
Dysarthria	27 (.18%)

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

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

Suicidal And Self-injurious Behavio...	1535 (10.13%)
Medication Errors	1165 (7.69%)
Cardiac Arrhythmias	1124 (7.42%)
Neurological	937 (6.18%)
Chemical Injury And Poisoning	766 (5.06%)
Respiratory	733 (4.84%)
Psychiatric	512 (3.38%)
Fatal Outcomes	438 (2.89%)
Gastrointestinal Signs	366 (2.42%)
Cardiac And Vascular Investigations	321 (2.12%)
Epidermal And Dermal Conditions	315 (2.08%)
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Injuries	252 (1.66%)
Therapeutic And Nontherapeutic Effe...	243 (1.6%)
Hematology Investigations	207 (1.37%)
Seizures	207 (1.37%)
Hepatic And Hepatobiliary	188 (1.24%)
Hepatobiliary	180 (1.19%)
Lower Respiratory Tract Disorders	164 (1.08%)
Deliria	159 (1.05%)
Anxiety Disorders	157 (1.04%)
Decreased And Nonspecific Blood Pre...	148 (.98%)
Movement Disorders	146 (.96%)
Muscle	143 (.94%)
Metabolic, Nutritional And Blood Ga...	136 (.9%)
Infections - Pathogen Unspecified	131 (.86%)
Toxicology And Therapeutic Drug Mon...	128 (.84%)
Sleep Disorders	127 (.84%)
Disturbances In Thinking	122 (.81%)
Allergic Conditions	119 (.79%)
Ocular Neuromuscular	111 (.73%)
Physical Examination Topics	105 (.69%)
Lifestyle Issues	98 (.65%)
Water, Electrolyte And Mineral	92 (.61%)
Gastrointestinal Motility And Defec...	86 (.57%)
Electrolyte And Fluid Balance Condi...	80 (.53%)
Renal Disorders	78 (.51%)
Mental Impairment	75 (.49%)
Neuromuscular	71 (.47%)
Enzyme	67 (.44%)
Body Temperature Conditions	63 (.42%)
Acid-base	61 (.4%)
Urinary Tract Signs	59 (.39%)
Renal And Urinary Tract Investigati...	58 (.38%)
Cardiac Disorder Signs	55 (.36%)
Musculoskeletal And Connective Tiss...	55 (.36%)
Product Quality Issues	55 (.36%)
Vascular Hypertensive	55 (.36%)
Headaches	54 (.36%)
Skin Appendage Conditions	54 (.36%)
Therapeutic Procedures And Supporti...	52 (.34%)
Increased Intracranial Pressure And...	50 (.33%)
Angiedema And Urticaria	49 (.32%)
Depressed Mood Disorders	45 (.3%)
Personality Disorders	43 (.28%)
Central Nervous System Vascular	42 (.28%)
Coronary Artery	42 (.28%)
Vascular	42 (.28%)
Eye	41 (.27%)
Legal Issues	41 (.27%)
Oral Soft Tissue Conditions	40 (.26%)
Upper Respiratory Tract Disorders	40 (.26%)
Gastrointestinal Hemorrhages	39 (.26%)
Vision	38 (.25%)
Appetite And General Nutritional	37 (.24%)
Heart Failures	37 (.24%)
White Blood Cell	37 (.24%)
Bronchial Disorders	36 (.24%)
Psychiatric And Behavioural Symptom...	36 (.24%)
Joint	33 (.22%)
Bone Disorders	32 (.21%)
Administration Site Reactions	31 (.2%)
Mood Disorders	31 (.2%)
Ocular Infections, Irritations And ...	31 (.2%)
Tongue Conditions	30 (.2%)
Bone And Joint Injuries	27 (.18%)
Vascular Hemorrhagic	27 (.18%)
Cranial Nerve Disorders	26 (.17%)
Glucose Metabolism Disorders	26 (.17%)
Changes In Physical Activity	25 (.16%)
Gastrointestinal Conditions	23 (.15%)
Neonatal And Perinatal Conditions	23 (.15%)
Procedural And Device Related Injur...	23 (.15%)
Bacterial Infectious	22 (.15%)
Skin Vascular Abnormalities	22 (.15%)
Arteriosclerosis, Stenosis, Vascula...	20 (.13%)
Neurological, Special Senses And Ps...	20 (.13%)
Anemias Nonhemolytic And Marrow Dep...	18 (.12%)
Encephalopathies	18 (.12%)
Myocardial	18 (.12%)
Sleep Disturbances	18 (.12%)
Gastrointestinal Inflammatory Condi...	17 (.11%)
Inner Ear And Viiith Cranial Nerve	16 (.11%)
Viral Infectious	16 (.11%)
Communication Disorders	15 (.1%)
Hematological And Lymphoid Tissue T...	15 (.1%)
Platelet	15 (.1%)
Schizophrenia And Other Psychotic	15 (.1%)
Bone, Calcium, Magnesium And Phosph...	14 (.09%)
Obstetric And Gynecological Therape...	14 (.09%)
Coagulopathies And Bleeding Diathes...	13 (.09%)
Embolism And Thrombosis	13 (.09%)

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