ROPINIROLE

Ropinirole Adverse Events Reported to the FDA Over Time

How are Ropinirole adverse event reports trending over time?

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

Most Common Ropinirole Adverse Events Reported to the FDA

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

Drug Ineffective	972 (4.53%)
Nausea	639 (2.98%)
Somnolence	589 (2.75%)
Insomnia	462 (2.16%)
Hallucination	365 (1.7%)
Dizziness	354 (1.65%)
Restless Legs Syndrome	350 (1.63%)
Fatigue	280 (1.31%)
Pathological Gambling	265 (1.24%)
Vomiting	257 (1.2%)
Tremor	256 (1.19%)
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Dyskinesia	236 (1.1%)
Sudden Onset Of Sleep	236 (1.1%)
Oedema Peripheral	202 (.94%)
Confusional State	196 (.91%)
Headache	192 (.9%)
Fall	191 (.89%)
Malaise	183 (.85%)
Gambling	178 (.83%)
Obsessive-compulsive Disorder	169 (.79%)
Feeling Abnormal	151 (.7%)
Asthenia	146 (.68%)
Loss Of Consciousness	146 (.68%)
Muscle Spasms	146 (.68%)
Depression	139 (.65%)
Dyspnoea	134 (.63%)
Pain In Extremity	133 (.62%)
Syncope	132 (.62%)
Abnormal Behaviour	128 (.6%)
Hyperhidrosis	128 (.6%)
Drug Interaction	126 (.59%)
Anxiety	120 (.56%)
Pain	114 (.53%)
Condition Aggravated	113 (.53%)
Death	109 (.51%)
Medication Error	107 (.5%)
Agitation	104 (.49%)
Sleep Disorder	104 (.49%)
Aggression	102 (.48%)
Ill-defined Disorder	102 (.48%)
Hallucination, Visual	101 (.47%)
Gait Disturbance	99 (.46%)
Hypersexuality	94 (.44%)
Product Quality Issue	94 (.44%)
Adverse Event	92 (.43%)
Psychotic Disorder	87 (.41%)
Weight Increased	86 (.4%)
Overdose	85 (.4%)
Restlessness	85 (.4%)
Drug Administration Error	84 (.39%)
Libido Increased	83 (.39%)
Drug Effect Decreased	81 (.38%)
Therapeutic Response Decreased	80 (.37%)
Hypoaesthesia	79 (.37%)
Palpitations	78 (.36%)
Diarrhoea	76 (.35%)
Balance Disorder	73 (.34%)
Arthralgia	70 (.33%)
Road Traffic Accident	68 (.32%)
Hypotension	67 (.31%)
Musculoskeletal Stiffness	67 (.31%)
Suicide Attempt	67 (.31%)
Constipation	66 (.31%)
Rash	66 (.31%)
Movement Disorder	65 (.3%)
Delirium	64 (.3%)
Paraesthesia	64 (.3%)
Weight Decreased	64 (.3%)
Chest Pain	63 (.29%)
Suicidal Ideation	62 (.29%)
Pyrexia	61 (.28%)
Amnesia	60 (.28%)
Abdominal Pain Upper	59 (.28%)
Delusion	58 (.27%)
Paranoia	58 (.27%)
Myalgia	57 (.27%)
Wrong Drug Administered	57 (.27%)
Pneumonia	56 (.26%)
Therapeutic Response Unexpected	56 (.26%)
Abnormal Dreams	54 (.25%)
Middle Insomnia	54 (.25%)
Nightmare	53 (.25%)
Withdrawal Syndrome	53 (.25%)
Cough	52 (.24%)
Medication Residue	49 (.23%)
Back Pain	48 (.22%)
Convulsion	48 (.22%)
Dysphagia	48 (.22%)
Mania	48 (.22%)
Impulse-control Disorder	47 (.22%)
Parkinsonism	47 (.22%)
Mobility Decreased	46 (.21%)
Disorientation	45 (.21%)
Dry Mouth	45 (.21%)
Fear	45 (.21%)
Heart Rate Increased	45 (.21%)
Joint Swelling	45 (.21%)
Muscular Weakness	44 (.21%)
Inappropriate Schedule Of Drug Admi...	43 (.2%)
Thinking Abnormal	43 (.2%)
Drug Dispensing Error	42 (.2%)

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

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

Neurological	2331 (10.87%)
Therapeutic And Nontherapeutic Effe...	1558 (7.27%)
Gastrointestinal Signs	1180 (5.5%)
Movement Disorders	872 (4.07%)
Sleep Disorders	827 (3.86%)
Disturbances In Thinking	669 (3.12%)
Anxiety Disorders	585 (2.73%)
Medication Errors	554 (2.58%)
Impulse Control	404 (1.88%)
Injuries	400 (1.87%)
Musculoskeletal And Connective Tiss...	394 (1.84%)
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Respiratory	371 (1.73%)
Muscle	357 (1.67%)
Lifestyle Issues	356 (1.66%)
Epidermal And Dermal Conditions	315 (1.47%)
Deliria	305 (1.42%)
Sleep Disturbances	298 (1.39%)
Sexual Dysfunctions, Disturbances A...	274 (1.28%)
Personality Disorders	273 (1.27%)
Mental Impairment	233 (1.09%)
Skin Appendage Conditions	229 (1.07%)
Psychiatric	218 (1.02%)
Depressed Mood Disorders	214 (1%)
Headaches	213 (.99%)
Cardiac Arrhythmias	202 (.94%)
Cardiac And Vascular Investigations	199 (.93%)
Suicidal And Self-injurious Behavio...	194 (.91%)
Joint	177 (.83%)
Gastrointestinal Motility And Defec...	174 (.81%)
Infections - Pathogen Unspecified	173 (.81%)
Product Quality Issues	171 (.8%)
Physical Examination Topics	164 (.77%)
Psychiatric And Behavioural Symptom...	164 (.77%)
Mood Disorders	146 (.68%)
Decreased And Nonspecific Blood Pre...	142 (.66%)
Vision	128 (.6%)
Changes In Physical Activity	127 (.59%)
Fatal Outcomes	125 (.58%)
Urinary Tract Signs	123 (.57%)
Central Nervous System Vascular	117 (.55%)
Cardiac Disorder Signs	110 (.51%)
Hepatobiliary	110 (.51%)
Schizophrenia And Other Psychotic	103 (.48%)
Bone And Joint Injuries	96 (.45%)
Hepatic And Hepatobiliary	85 (.4%)
Electrolyte And Fluid Balance Condi...	82 (.38%)
Neuromuscular	81 (.38%)
Appetite And General Nutritional	78 (.36%)
Manic And Bipolar Mood Disorders	73 (.34%)
Seizures	73 (.34%)
Body Temperature Conditions	70 (.33%)
Therapeutic Procedures And Supporti...	67 (.31%)
Inner Ear And Viiith Cranial Nerve	66 (.31%)
Hematology Investigations	65 (.3%)
Lower Respiratory Tract Disorders	64 (.3%)
Legal Issues	61 (.28%)
Salivary Gland Conditions	58 (.27%)
Upper Respiratory Tract Disorders	56 (.26%)
Vascular	56 (.26%)
Economic And Housing Issues	53 (.25%)
Coronary Artery	52 (.24%)
Eating Disorders	50 (.23%)
Sexual Function And Fertility	49 (.23%)
Renal And Urinary Tract Investigati...	47 (.22%)
Cardiac Valve	44 (.21%)
Renal Disorders	44 (.21%)
Enzyme	42 (.2%)
Gastrointestinal Hemorrhages	39 (.18%)
Bronchial Disorders	38 (.18%)
Heart Failures	36 (.17%)
Toxicology And Therapeutic Drug Mon...	36 (.17%)
Angiedema And Urticaria	35 (.16%)
Glucose Metabolism Disorders	35 (.16%)
Oral Soft Tissue Conditions	35 (.16%)
Eye	34 (.16%)
Allergic Conditions	33 (.15%)
Gastrointestinal Conditions	33 (.15%)
Breast	32 (.15%)
Vascular Hypertensive	32 (.15%)
Communication Disorders	29 (.14%)
Chemical Injury And Poisoning	27 (.13%)
Embolism And Thrombosis	27 (.13%)
Gender Related Factors	27 (.13%)
Peripheral Neuropathies	27 (.13%)
Viral Infectious	27 (.13%)
White Blood Cell	26 (.12%)
Metabolic, Nutritional And Blood Ga...	25 (.12%)
Tongue Conditions	25 (.12%)
Water, Electrolyte And Mineral	25 (.12%)
Dental And Gingival Conditions	24 (.11%)
Ocular Neuromuscular	23 (.11%)
Pleural	23 (.11%)
Anemias Nonhemolytic And Marrow Dep...	22 (.1%)
Gastrointestinal Inflammatory Condi...	22 (.1%)
Gastrointestinal Neoplasms Malignan...	21 (.1%)
Myocardial	20 (.09%)
Family Issues	19 (.09%)
Bladder And Bladder Neck Disorders	18 (.08%)
Connective Tissue Disorders	18 (.08%)
Gastrointestinal Stenosis And Obstr...	18 (.08%)
Arteriosclerosis, Stenosis, Vascula...	17 (.08%)

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