PRAMIPEXOLE

Pramipexole Adverse Events Reported to the FDA Over Time

How are Pramipexole adverse event reports trending over time?

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

Most Common Pramipexole Adverse Events Reported to the FDA

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

Pathological Gambling	1414 (6.51%)
Obsessive-compulsive Disorder	939 (4.32%)
Emotional Distress	748 (3.44%)
Pain	585 (2.69%)
Drug Ineffective	474 (2.18%)
Depression	463 (2.13%)
Compulsive Shopping	404 (1.86%)
Hypersexuality	330 (1.52%)
Somnolence	330 (1.52%)
Anxiety	326 (1.5%)
Insomnia	314 (1.44%)
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Hallucination	270 (1.24%)
Nausea	265 (1.22%)
Condition Aggravated	225 (1.04%)
Fatigue	217 (1%)
Gambling	217 (1%)
Suicidal Ideation	216 (.99%)
Dizziness	209 (.96%)
Restless Legs Syndrome	186 (.86%)
Dyskinesia	183 (.84%)
Hyperphagia	173 (.8%)
Confusional State	167 (.77%)
Weight Increased	167 (.77%)
Fall	158 (.73%)
Impulse-control Disorder	158 (.73%)
Abnormal Behaviour	156 (.72%)
Tremor	149 (.69%)
Suicide Attempt	145 (.67%)
Oedema Peripheral	143 (.66%)
Drug Effect Decreased	126 (.58%)
Vomiting	125 (.58%)
Pain In Extremity	124 (.57%)
Headache	120 (.55%)
Sleep Disorder	118 (.54%)
Hallucination, Visual	113 (.52%)
Economic Problem	111 (.51%)
Sudden Onset Of Sleep	108 (.5%)
Asthenia	105 (.48%)
Dyspnoea	103 (.47%)
Gait Disturbance	103 (.47%)
Stress	103 (.47%)
Feeling Abnormal	85 (.39%)
Overdose	84 (.39%)
Mania	82 (.38%)
Libido Increased	81 (.37%)
Muscle Spasms	81 (.37%)
Loss Of Consciousness	80 (.37%)
Delusion	75 (.35%)
Syncope	74 (.34%)
Aggression	73 (.34%)
Personality Change	73 (.34%)
Road Traffic Accident	72 (.33%)
Hypotension	71 (.33%)
Weight Decreased	71 (.33%)
Hypomania	70 (.32%)
Death	68 (.31%)
Movement Disorder	68 (.31%)
Restlessness	68 (.31%)
Fear	66 (.3%)
Rash	64 (.29%)
Injury	61 (.28%)
Disease Progression	60 (.28%)
Balance Disorder	58 (.27%)
Hyperhidrosis	57 (.26%)
Hypoaesthesia	57 (.26%)
Convulsion	56 (.26%)
Diarrhoea	56 (.26%)
Hypertension	56 (.26%)
Limb Discomfort	56 (.26%)
Visual Impairment	56 (.26%)
Adverse Drug Reaction	55 (.25%)
Arthralgia	55 (.25%)
Paraesthesia	54 (.25%)
Psychotic Disorder	54 (.25%)
Activities Of Daily Living Impaired	53 (.24%)
Chest Pain	53 (.24%)
Joint Swelling	53 (.24%)
Psychomotor Hyperactivity	53 (.24%)
Compulsive Sexual Behaviour	52 (.24%)
Agitation	51 (.23%)
Amnesia	51 (.23%)
Dyspepsia	50 (.23%)
Muscular Weakness	50 (.23%)
Delirium	47 (.22%)
Myalgia	47 (.22%)
Nightmare	46 (.21%)
Vision Blurred	46 (.21%)
Abnormal Dreams	45 (.21%)
Hallucination, Auditory	44 (.2%)
Musculoskeletal Stiffness	44 (.2%)
Malaise	43 (.2%)
Back Pain	42 (.19%)
Constipation	42 (.19%)
Jealous Delusion	42 (.19%)
Therapeutic Response Decreased	42 (.19%)
Disturbance In Attention	41 (.19%)
Dopamine Dysregulation Syndrome	41 (.19%)
Oedema	41 (.19%)
Palpitations	41 (.19%)
Drug Interaction	39 (.18%)
Pneumonia	39 (.18%)

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

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

Impulse Control	2016 (9.27%)
Anxiety Disorders	1654 (7.61%)
Neurological	1401 (6.45%)
Mood Disorders	938 (4.32%)
Therapeutic And Nontherapeutic Effe...	849 (3.91%)
Disturbances In Thinking	642 (2.95%)
Movement Disorders	632 (2.91%)
Sleep Disorders	631 (2.9%)
Gastrointestinal Signs	618 (2.84%)
Depressed Mood Disorders	569 (2.62%)
Sexual Dysfunctions, Disturbances A...	545 (2.51%)
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Suicidal And Self-injurious Behavio...	406 (1.87%)
Lifestyle Issues	393 (1.81%)
Injuries	391 (1.8%)
Musculoskeletal And Connective Tiss...	363 (1.67%)
Muscle	337 (1.55%)
Respiratory	281 (1.29%)
Personality Disorders	275 (1.27%)
Physical Examination Topics	252 (1.16%)
Medication Errors	249 (1.15%)
Appetite And General Nutritional	248 (1.14%)
Epidermal And Dermal Conditions	245 (1.13%)
Psychiatric	241 (1.11%)
Deliria	235 (1.08%)
Infections - Pathogen Unspecified	224 (1.03%)
Mental Impairment	210 (.97%)
Manic And Bipolar Mood Disorders	203 (.93%)
Psychiatric And Behavioural Symptom...	185 (.85%)
Sleep Disturbances	153 (.7%)
Vision	151 (.69%)
Joint	147 (.68%)
Urinary Tract Signs	143 (.66%)
Headaches	140 (.64%)
Economic And Housing Issues	134 (.62%)
Gastrointestinal Motility And Defec...	127 (.58%)
Cardiac And Vascular Investigations	116 (.53%)
Decreased And Nonspecific Blood Pre...	115 (.53%)
Cardiac Arrhythmias	112 (.52%)
Skin Appendage Conditions	111 (.51%)
Changes In Physical Activity	108 (.5%)
Bone And Joint Injuries	107 (.49%)
Schizophrenia And Other Psychotic	87 (.4%)
Electrolyte And Fluid Balance Condi...	78 (.36%)
Fatal Outcomes	77 (.35%)
Eating Disorders	75 (.35%)
Vascular Hypertensive	73 (.34%)
Neuromuscular	71 (.33%)
Renal Disorders	70 (.32%)
Seizures	69 (.32%)
Coronary Artery	68 (.31%)
Central Nervous System Vascular	65 (.3%)
Lower Respiratory Tract Disorders	63 (.29%)
Upper Respiratory Tract Disorders	62 (.29%)
Cardiac Disorder Signs	57 (.26%)
Family Issues	53 (.24%)
Hepatic And Hepatobiliary	51 (.23%)
Sexual Function And Fertility	49 (.23%)
Eye	46 (.21%)
Salivary Gland Conditions	46 (.21%)
Heart Failures	45 (.21%)
Product Quality Issues	43 (.2%)
Hepatobiliary	42 (.19%)
Legal Issues	41 (.19%)
Allergic Conditions	40 (.18%)
Hematology Investigations	39 (.18%)
Body Temperature Conditions	38 (.17%)
Bronchial Disorders	38 (.17%)
Enzyme	38 (.17%)
Hypothalamus And Pituitary Gland	34 (.16%)
Inner Ear And Viiith Cranial Nerve	31 (.14%)
Cardiac Valve	30 (.14%)
Gastrointestinal Stenosis And Obstr...	28 (.13%)
Musculoskeletal And Connective Tiss...	28 (.13%)
Vascular	28 (.13%)
Renal And Urinary Tract Investigati...	27 (.12%)
White Blood Cell	27 (.12%)
Bacterial Infectious	26 (.12%)
Peripheral Neuropathies	26 (.12%)
Metabolic, Nutritional And Blood Ga...	25 (.12%)
Hearing	24 (.11%)
Nephropathies	24 (.11%)
Therapeutic Procedures And Supporti...	24 (.11%)
Dental And Gingival Conditions	23 (.11%)
Pulmonary Vascular	23 (.11%)
Cognitive And Attention Disorders	22 (.1%)
Arteriosclerosis, Stenosis, Vascula...	21 (.1%)
Gastrointestinal Hemorrhages	21 (.1%)
Oral Soft Tissue Conditions	21 (.1%)
Bone Disorders	20 (.09%)
Communication Disorders	19 (.09%)
Lipid Analyses	19 (.09%)
Skin Vascular Abnormalities	19 (.09%)
Bladder And Bladder Neck Disorders	18 (.08%)
Cranial Nerve Disorders	18 (.08%)
Ocular Neuromuscular	18 (.08%)
Pleural	17 (.08%)
Anemias Nonhemolytic And Marrow Dep...	16 (.07%)
Encephalopathies	16 (.07%)
Gastrointestinal Ulceration And Per...	16 (.07%)
Thyroid Gland	16 (.07%)
Endocrine Investigations	15 (.07%)

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