HYDROMORPHONE

Hydromorphone Adverse Events Reported to the FDA Over Time

How are Hydromorphone adverse event reports trending over time?

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

Most Common Hydromorphone Adverse Events Reported to the FDA

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

Nausea	259 (1.68%)
Drug Ineffective	237 (1.53%)
Pain	191 (1.24%)
Somnolence	191 (1.24%)
Vomiting	185 (1.2%)
Completed Suicide	180 (1.17%)
Dyspnoea	177 (1.15%)
Overdose	164 (1.06%)
Confusional State	160 (1.04%)
Unresponsive To Stimuli	160 (1.04%)
Death	144 (.93%)
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Drug Toxicity	141 (.91%)
Medication Error	135 (.87%)
Constipation	131 (.85%)
Respiratory Arrest	131 (.85%)
Hypotension	130 (.84%)
Loss Of Consciousness	128 (.83%)
Respiratory Depression	122 (.79%)
Sedation	104 (.67%)
Dehydration	103 (.67%)
Delirium	103 (.67%)
Cardio-respiratory Arrest	102 (.66%)
Coma	102 (.66%)
Dizziness	101 (.65%)
Drug Withdrawal Syndrome	98 (.63%)
Cardiac Arrest	96 (.62%)
Pneumonia	95 (.62%)
Back Pain	94 (.61%)
Depressed Level Of Consciousness	94 (.61%)
Abdominal Pain	93 (.6%)
Headache	92 (.6%)
Agitation	86 (.56%)
Asthenia	86 (.56%)
Weight Decreased	85 (.55%)
Fatigue	84 (.54%)
Pruritus	84 (.54%)
Incorrect Dose Administered	82 (.53%)
Hyperhidrosis	80 (.52%)
Hallucination	79 (.51%)
Fall	74 (.48%)
Lethargy	74 (.48%)
Drug Hypersensitivity	73 (.47%)
Drug Interaction	72 (.47%)
Oxygen Saturation Decreased	72 (.47%)
Drug Dependence	70 (.45%)
Disorientation	69 (.45%)
Feeling Abnormal	69 (.45%)
Respiratory Failure	69 (.45%)
Anxiety	68 (.44%)
Diarrhoea	68 (.44%)
Hyperaesthesia	63 (.41%)
Intentional Drug Misuse	63 (.41%)
Mental Status Changes	63 (.41%)
Condition Aggravated	62 (.4%)
Drug Effect Decreased	60 (.39%)
Malaise	59 (.38%)
Convulsion	58 (.38%)
Arthralgia	57 (.37%)
Chest Pain	57 (.37%)
Inadequate Analgesia	57 (.37%)
Tachycardia	56 (.36%)
Accidental Overdose	55 (.36%)
Respiratory Rate Decreased	55 (.36%)
Depression	54 (.35%)
Insomnia	54 (.35%)
Oedema Peripheral	53 (.34%)
Multiple Drug Overdose	52 (.34%)
Substance Abuse	52 (.34%)
Tremor	50 (.32%)
Aggression	49 (.32%)
Pyrexia	49 (.32%)
Muscle Spasms	48 (.31%)
Respiratory Distress	48 (.31%)
Blood Pressure Decreased	47 (.3%)
Pulmonary Oedema	47 (.3%)
Urinary Tract Infection	47 (.3%)
Drug Abuser	46 (.3%)
Rash	46 (.3%)
Suicidal Ideation	46 (.3%)
Hypoxia	44 (.28%)
Sepsis	44 (.28%)
Disease Progression	43 (.28%)
Gait Disturbance	43 (.28%)
Heart Rate Increased	43 (.28%)
Miosis	43 (.28%)
Decreased Appetite	42 (.27%)
Drug Abuse	42 (.27%)
Muscular Weakness	42 (.27%)
Pulmonary Embolism	42 (.27%)
Renal Failure Acute	42 (.27%)
Apnoea	41 (.27%)
Restlessness	41 (.27%)
Accidental Death	40 (.26%)
Contusion	40 (.26%)
Suicide Attempt	40 (.26%)
Abdominal Distension	38 (.25%)
Inappropriate Schedule Of Drug Admi...	38 (.25%)
Cerebrovascular Accident	37 (.24%)
Dyskinesia	37 (.24%)
Jaundice	37 (.24%)
Myoclonus	37 (.24%)

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

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

Neurological	1413 (9.15%)
Respiratory	930 (6.02%)
Medication Errors	795 (5.15%)
Gastrointestinal Signs	738 (4.78%)
Therapeutic And Nontherapeutic Effe...	590 (3.82%)
Cardiac Arrhythmias	384 (2.49%)
Psychiatric	364 (2.36%)
Deliria	332 (2.15%)
Epidermal And Dermal Conditions	321 (2.08%)
Infections - Pathogen Unspecified	321 (2.08%)
Chemical Injury And Poisoning	277 (1.79%)
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Suicidal And Self-injurious Behavio...	276 (1.79%)
Gastrointestinal Motility And Defec...	229 (1.48%)
Injuries	222 (1.44%)
Cardiac And Vascular Investigations	215 (1.39%)
Musculoskeletal And Connective Tiss...	215 (1.39%)
Physical Examination Topics	212 (1.37%)
Fatal Outcomes	197 (1.28%)
Anxiety Disorders	191 (1.24%)
Electrolyte And Fluid Balance Condi...	169 (1.09%)
Muscle	165 (1.07%)
Decreased And Nonspecific Blood Pre...	163 (1.06%)
Lower Respiratory Tract Disorders	163 (1.06%)
Metabolic, Nutritional And Blood Ga...	159 (1.03%)
Disturbances In Thinking	144 (.93%)
Procedural And Device Related Injur...	143 (.93%)
Movement Disorders	142 (.92%)
Allergic Conditions	136 (.88%)
Lifestyle Issues	132 (.85%)
Hematology Investigations	129 (.84%)
Headaches	116 (.75%)
Skin Appendage Conditions	114 (.74%)
Sleep Disorders	113 (.73%)
Personality Disorders	107 (.69%)
Joint	105 (.68%)
Hepatic And Hepatobiliary	103 (.67%)
Central Nervous System Vascular	102 (.66%)
Renal Disorders	102 (.66%)
Hepatobiliary	89 (.58%)
Bacterial Infectious	88 (.57%)
Mental Impairment	87 (.56%)
Appetite And General Nutritional	85 (.55%)
Urinary Tract Signs	80 (.52%)
Bone And Joint Injuries	77 (.5%)
Cardiac Disorder Signs	77 (.5%)
Dental And Gingival Conditions	77 (.5%)
Seizures	77 (.5%)
Administration Site Reactions	74 (.48%)
Gastrointestinal Stenosis And Obstr...	72 (.47%)
Renal And Urinary Tract Investigati...	72 (.47%)
Coronary Artery	68 (.44%)
Ocular Neuromuscular	67 (.43%)
Product Quality Issues	67 (.43%)
Toxicology And Therapeutic Drug Mon...	62 (.4%)
Therapeutic Procedures And Supporti...	60 (.39%)
Mood Disorders	59 (.38%)
Depressed Mood Disorders	57 (.37%)
Miscellaneous And Site Unspecified ...	57 (.37%)
Viral Infectious	56 (.36%)
Vision	53 (.34%)
Body Temperature Conditions	52 (.34%)
Changes In Physical Activity	52 (.34%)
Pulmonary Vascular	48 (.31%)
Fungal Infectious	47 (.3%)
Bronchial Disorders	45 (.29%)
Glucose Metabolism Disorders	42 (.27%)
White Blood Cell	42 (.27%)
Anemias Nonhemolytic And Marrow Dep...	41 (.27%)
Enzyme	40 (.26%)
Musculoskeletal And Connective Tiss...	40 (.26%)
Encephalopathies	39 (.25%)
Water, Electrolyte And Mineral	38 (.25%)
Neuromuscular	37 (.24%)
Spinal Cord And Nerve Root	36 (.23%)
Metastases	35 (.23%)
Vascular Hypertensive	35 (.23%)
Myocardial	34 (.22%)
Oral Soft Tissue Conditions	34 (.22%)
Schizophrenia And Other Psychotic	34 (.22%)
Gastrointestinal Hemorrhages	32 (.21%)
Upper Respiratory Tract Disorders	32 (.21%)
Legal Issues	31 (.2%)
Angiedema And Urticaria	30 (.19%)
Embolism And Thrombosis	29 (.19%)
Bone Disorders	28 (.18%)
Heart Failures	28 (.18%)
Pleural	27 (.17%)
Gastrointestinal Inflammatory Condi...	26 (.17%)
Vascular	26 (.17%)
Eye	23 (.15%)
Inner Ear And Viiith Cranial Nerve	22 (.14%)
Psychiatric And Behavioural Symptom...	21 (.14%)
Gastrointestinal Conditions	20 (.13%)
Communication Disorders	19 (.12%)
Neurological, Special Senses And Ps...	19 (.12%)
Salivary Gland Conditions	19 (.12%)
Vulvovaginal Disorders	19 (.12%)
Peripheral Neuropathies	17 (.11%)
Platelet	17 (.11%)
Spleen, Lymphatic And Reticulendoth...	17 (.11%)
Increased Intracranial Pressure And...	16 (.1%)

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