PROMETHAZINE

Promethazine Adverse Events Reported to the FDA Over Time

How are Promethazine adverse event reports trending over time?

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

Most Common Promethazine Adverse Events Reported to the FDA

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

Completed Suicide	243 (2.08%)
Nausea	216 (1.85%)
Cardiac Arrest	177 (1.51%)
Somnolence	168 (1.44%)
Respiratory Arrest	155 (1.33%)
Vomiting	150 (1.28%)
Drug Toxicity	148 (1.27%)
Pain	140 (1.2%)
Confusional State	132 (1.13%)
Dizziness	118 (1.01%)
Cardio-respiratory Arrest	116 (.99%)
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Suicide Attempt	113 (.97%)
Anxiety	108 (.92%)
Depression	94 (.8%)
Overdose	94 (.8%)
Death	91 (.78%)
Tremor	85 (.73%)
Diarrhoea	81 (.69%)
Headache	81 (.69%)
Dyspnoea	80 (.68%)
Drug Ineffective	79 (.68%)
Multiple Drug Overdose	79 (.68%)
Malaise	78 (.67%)
Aggression	75 (.64%)
Insomnia	74 (.63%)
Lethargy	70 (.6%)
Agitation	68 (.58%)
Drug Interaction	68 (.58%)
Syncope	68 (.58%)
Poisoning	67 (.57%)
Pain In Extremity	65 (.56%)
Hyperhidrosis	62 (.53%)
Fatigue	61 (.52%)
Fall	60 (.51%)
Loss Of Consciousness	60 (.51%)
Urinary Tract Infection	60 (.51%)
Weight Decreased	59 (.5%)
Medication Error	58 (.5%)
Pyrexia	58 (.5%)
Dehydration	57 (.49%)
Depressed Level Of Consciousness	57 (.49%)
Suicidal Ideation	57 (.49%)
Multiple Drug Overdose Intentional	56 (.48%)
Anaemia	55 (.47%)
Hypotension	55 (.47%)
Muscle Twitching	55 (.47%)
Drug Exposure During Pregnancy	54 (.46%)
Oedema Peripheral	54 (.46%)
Hypersensitivity	52 (.45%)
Hallucination	50 (.43%)
Decreased Appetite	48 (.41%)
Drug Hypersensitivity	48 (.41%)
Coma	46 (.39%)
Intentional Overdose	44 (.38%)
Asthenia	43 (.37%)
Feeling Abnormal	43 (.37%)
Mental Status Changes	42 (.36%)
Condition Aggravated	41 (.35%)
Myalgia	41 (.35%)
Chest Pain	40 (.34%)
Erythema	40 (.34%)
Pneumonia	40 (.34%)
Convulsion	39 (.33%)
Injection Site Pain	39 (.33%)
Intentional Drug Misuse	39 (.33%)
Neuroleptic Malignant Syndrome	39 (.33%)
Muscle Atrophy	38 (.33%)
Pruritus	38 (.33%)
Muscle Spasms	37 (.32%)
Panic Attack	37 (.32%)
Tachycardia	37 (.32%)
Burning Sensation	36 (.31%)
Hypochondriasis	36 (.31%)
Heart Rate Increased	35 (.3%)
Drug Abuse	34 (.29%)
Pulmonary Congestion	33 (.28%)
Constipation	32 (.27%)
Hypertension	32 (.27%)
Hypoaesthesia	32 (.27%)
Restlessness	32 (.27%)
Aspartate Aminotransferase Increase...	31 (.27%)
Oral Discomfort	31 (.27%)
Paraesthesia	31 (.27%)
Respiratory Failure	31 (.27%)
Sedation	31 (.27%)
Pulmonary Embolism	30 (.26%)
Swelling	30 (.26%)
Abdominal Pain	29 (.25%)
Dysarthria	29 (.25%)
Poisoning Deliberate	29 (.25%)
Unresponsive To Stimuli	29 (.25%)
Activated Partial Thromboplastin Ti...	28 (.24%)
Blood Glucose Increased	28 (.24%)
Disorientation	28 (.24%)
Dystonia	28 (.24%)
Alanine Aminotransferase Increased	27 (.23%)
Blood Pressure Increased	27 (.23%)
Dyskinesia	27 (.23%)
Oxygen Saturation Decreased	27 (.23%)
Rhabdomyolysis	27 (.23%)
Contusion	26 (.22%)

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

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

Neurological	938 (8.03%)
Medication Errors	493 (4.22%)
Gastrointestinal Signs	478 (4.09%)
Respiratory	463 (3.96%)
Cardiac Arrhythmias	460 (3.94%)
Suicidal And Self-injurious Behavio...	425 (3.64%)
Chemical Injury And Poisoning	330 (2.82%)
Epidermal And Dermal Conditions	304 (2.6%)
Anxiety Disorders	266 (2.28%)
Infections - Pathogen Unspecified	243 (2.08%)
Muscle	243 (2.08%)
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Movement Disorders	231 (1.98%)
Administration Site Reactions	218 (1.87%)
Therapeutic And Nontherapeutic Effe...	197 (1.69%)
Deliria	185 (1.58%)
Hematology Investigations	184 (1.57%)
Injuries	165 (1.41%)
Cardiac And Vascular Investigations	161 (1.38%)
Psychiatric	147 (1.26%)
Gastrointestinal Motility And Defec...	133 (1.14%)
Musculoskeletal And Connective Tiss...	132 (1.13%)
Lower Respiratory Tract Disorders	131 (1.12%)
Sleep Disorders	130 (1.11%)
Allergic Conditions	119 (1.02%)
Physical Examination Topics	119 (1.02%)
Disturbances In Thinking	115 (.98%)
Fatal Outcomes	111 (.95%)
Depressed Mood Disorders	105 (.9%)
Electrolyte And Fluid Balance Condi...	105 (.9%)
Bacterial Infectious	96 (.82%)
Headaches	96 (.82%)
Hepatic And Hepatobiliary	95 (.81%)
Personality Disorders	95 (.81%)
Metabolic, Nutritional And Blood Ga...	90 (.77%)
Lifestyle Issues	87 (.74%)
Appetite And General Nutritional	82 (.7%)
Hepatobiliary	81 (.69%)
Decreased And Nonspecific Blood Pre...	79 (.68%)
Anemias Nonhemolytic And Marrow Dep...	73 (.62%)
Neuromuscular	71 (.61%)
Skin Appendage Conditions	71 (.61%)
Arteriosclerosis, Stenosis, Vascula...	69 (.59%)
Body Temperature Conditions	65 (.56%)
Mood Disorders	63 (.54%)
Water, Electrolyte And Mineral	63 (.54%)
Seizures	61 (.52%)
Mental Impairment	59 (.5%)
Renal Disorders	59 (.5%)
Cardiac Disorder Signs	58 (.5%)
Joint	58 (.5%)
Oral Soft Tissue Conditions	56 (.48%)
Embolism And Thrombosis	51 (.44%)
Tissue	48 (.41%)
White Blood Cell	48 (.41%)
Renal And Urinary Tract Investigati...	47 (.4%)
Vascular	45 (.39%)
Somatoform And Factitious	44 (.38%)
Changes In Physical Activity	42 (.36%)
Pulmonary Vascular	41 (.35%)
Procedural And Device Related Injur...	40 (.34%)
Bone And Joint Injuries	39 (.33%)
Central Nervous System Vascular	38 (.33%)
Urinary Tract Signs	37 (.32%)
Myocardial	36 (.31%)
Psychiatric And Behavioural Symptom...	36 (.31%)
Ocular Neuromuscular	35 (.3%)
Skin Vascular Abnormalities	34 (.29%)
Vascular Hypertensive	33 (.28%)
Bone And Joint Therapeutic Procedur...	30 (.26%)
Enzyme	30 (.26%)
Toxicology And Therapeutic Drug Mon...	29 (.25%)
Coronary Artery	28 (.24%)
Schizophrenia And Other Psychotic	26 (.22%)
Coagulopathies And Bleeding Diathes...	25 (.21%)
Lipid Analyses	25 (.21%)
Upper Respiratory Tract Disorders	25 (.21%)
Abortions And Stillbirth	24 (.21%)
Acid-base	24 (.21%)
Fungal Infectious	24 (.21%)
Gastrointestinal Conditions	24 (.21%)
Glucose Metabolism Disorders	24 (.21%)
Viral Infectious	23 (.2%)
Encephalopathies	22 (.19%)
Gastrointestinal Hemorrhages	21 (.18%)
Vision	21 (.18%)
Gastrointestinal Tract Disorders Co...	20 (.17%)
Musculoskeletal And Connective Tiss...	20 (.17%)
Heart Failures	19 (.16%)
Microbiology And Serology	18 (.15%)
Communication Disorders	17 (.15%)
Musculoskeletal And Connective Tiss...	17 (.15%)
Neonatal And Perinatal Conditions	17 (.15%)
Vascular Hemorrhagic	17 (.15%)
Peripheral Neuropathies	16 (.14%)
Platelet	16 (.14%)
Bronchial Disorders	15 (.13%)
Manic And Bipolar Mood Disorders	15 (.13%)
Neonatal Respiratory	15 (.13%)
Protein And Chemistry Analyses	15 (.13%)
Eye	14 (.12%)
Gallbladder	14 (.12%)

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