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Mirapex (Pramipexole) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Mirapex (Pramipexole) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (237)
Death (15)
Life Threatening Events (2)
Disability (9)

Reports by Reaction Type

Obsessive-Compulsive Disorder (99)Pathological Gambling (99)Emotional Distress (84)Pain (83)Compulsive Shopping (44)Suicidal Ideation (31)Hypersexuality (30)Depression (30)Somnolence (27)Hyperphagia (19)Insomnia (16)Anxiety (14)

Below are a few examples of reports where side effects / adverse reactions may be related to Mirapex (Pramipexole). For a complete list or a specific selection of reports, please use the links above.

Possible Mirapex side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: female

Reactions: Dyspnoea, Chest Discomfort, Nausea, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mirapex

Other drugs received by patient: Losartan Potassium; Lovastatin; Pristiq; Hydrocodone Bitartrate; Opana; Nexium; Clonazepam; Lovaza; Carvedilol; Carisoprodol; Aspirin



Possible Mirapex side effects in

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient:

Reactions: Somnolence

Drug(s) suspected as cause:
Mirapex
    Dosage: 1 df, qd

Sinemet
    Dosage: 2 df, bid
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2007-01-01

Other drugs received by patient: Simvastatin; Metformin; Diovan; Lidoderm; Prevacid; Vicodin; Levothyroxine Sodium; Cogentin



Possible Mirapex side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-20

Patient: female

Reactions: Mood Altered, Impulsive Behaviour

Drug(s) suspected as cause:
Mirapex

Other drugs received by patient: Levoxyl



Possible Mirapex side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female

Reactions: Gastric Disorder

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: female

Reactions: Nausea, Retching, Dizziness, Fall, Cold Sweat

Drug(s) suspected as cause:
Mirapex

Other drugs received by patient: Zoloft



Possible Mirapex side effects in 67 year old female

Reported by a consumer/non-health professional from Canada on 2012-08-13

Patient: 67 year old female

Reactions: Weight Decreased, Fall, Viith Nerve Paralysis, Arthralgia, Balance Disorder, Memory Impairment, Asthenia, Hallucination, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mirapex

Other drugs received by patient: Dalmane; Fosamax



Possible Mirapex side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: female

Reactions: Obsessive-Compulsive Disorder, Upper Limb Fracture, Pain, Compulsive Hoarding, Somnolence, Fall, Suicidal Ideation, Road Traffic Accident, Impulse-Control Disorder, Hypersexuality, Chest Pain, Pathological Gambling, Cellulitis, Drug Withdrawal Syndrome, Toxicity To Various Agents, HIP Fracture, Emotional Distress, Joint Swelling, Insomnia, Visual Impairment, Compulsive Shopping, Back Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mirapex
    Indication: Parkinson's Disease
    Start date: 1997-01-01
    End date: 2010-03-21

Mirapex
    Start date: 2010-03-29
    End date: 2011-02-24



Possible Mirapex side effects in female

Reported by a pharmacist from United States on 2012-08-07

Patient: female

Reactions: Vibratory Sense Increased

Drug(s) suspected as cause:
Mirapex

Other drugs received by patient: Fluticasone Furoate; Fentanyl; Loratadine; Enbrel; Nystatin; Acetaminophen; Lidoderm; Mucinex; Sinemet; Xopenex; Raloxifene Hydrochloride; Levothyroxine Sodium; Pantoprazole; Ergocalciferol



Possible Mirapex side effects in male

Reported by a physician from United States on 2012-08-06

Patient: male

Reactions: Tinnitus, Dyskinesia

Drug(s) suspected as cause:
Mirapex
    Dosage: 0.25 mg
    Administration route: Oral
    Start date: 2012-07-01

Mirapex
    Dosage: 0.5 mg
    Administration route: Oral
    Indication: Restless Legs Syndrome
    Start date: 2012-07-01
    End date: 2012-07-01



Possible Mirapex side effects in 41 year old female

Reported by a individual with unspecified qualification from United States on 2012-08-01

Patient: 41 year old female, weighing 77.1 kg (169.6 pounds)

Reactions: Economic Problem, Victim of Sexual Abuse, Partner Stress, Incorrect Dose Administered, Abnormal Behaviour, Headache, Homeless, Unemployment, Thinking Abnormal, Insomnia, Suicide Attempt, Mood Swings

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: female

Reactions: Eye Infection Toxoplasmal, Incorrect Dose Administered, Blindness, Retinal Artery Occlusion, Corneal Deposits

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Mirapex

Other drugs received by patient: Plavix; Effexor



Possible Mirapex side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-30

Patient: male

Reactions: Speech Disorder, Fatigue, Feeling Abnormal

Drug(s) suspected as cause:
Mirapex
    Dosage: 0.5 mg
    Administration route: Oral
    Start date: 2012-07-16

Mirapex
    Dosage: 0.375 mg
    Administration route: Oral
    Indication: Parkinson's Disease
    End date: 2012-07-01

Other drugs received by patient: Fluoxetine HCL; Carbidopa and Levodopa; Atenolol



Possible Mirapex side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-25

Patient: female

Reactions: Speech Disorder, Aphonia

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: female, weighing 90.7 kg (199.6 pounds)

Reactions: Mental Impairment, Pathological Gambling, Pain, Stress

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in female

Reported by a pharmacist from United States on 2012-07-18

Patient: female

Reactions: Vibratory Sense Increased

Drug(s) suspected as cause:
Mirapex

Other drugs received by patient: Enbrel; Mucinex; Xopenex; Fentanyl; Nystatin; Sinemet; Ergocalciferol; Fluticasone Propionate; Lidoderm; Loratadine; Pantoprazole; Acetaminophen; Levothyroxine Sodium; Evista



Possible Mirapex side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: male, weighing 65.8 kg (144.7 pounds)

Reactions: Obsessive-Compulsive Disorder, Pain, Condition Aggravated, Compulsive Hoarding, Stress, Somnolence, Suicidal Ideation, Emotional Distress, Depression, Compulsive Shopping, Acute Myocardial Infarction

Drug(s) suspected as cause:
Mirapex
    Indication: Restless Legs Syndrome
    Start date: 2001-04-09
    End date: 2011-01-19

Mirapex
    Indication: Periodic Limb Movement Disorder



Possible Mirapex side effects in 49 year old male

Reported by a physician from United States on 2012-07-17

Patient: 49 year old male

Reactions: Osteonecrosis, Arthralgia

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in female

Reported by a pharmacist from United States on 2012-07-06

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: male

Reactions: Rhinorrhoea, Somnolence

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in 74 year old male

Reported by a consumer/non-health professional from India on 2012-07-03

Patient: 74 year old male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in 57 year old female

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-07-03

Patient: 57 year old female, weighing 66.0 kg (145.2 pounds)

Reactions: Pathological Gambling, Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: male

Reactions: Narcolepsy, Fatigue

Drug(s) suspected as cause:
Mirapex

Other drugs received by patient: Vitamin TAB; Folic Acid; Aspirin; Losartan Potassium; Simvastatin; Omeprazole



Possible Mirapex side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-27

Patient: female

Reactions: Disturbance in Sexual Arousal

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-25

Patient: female

Reactions: Tinnitus, Disturbance in Sexual Arousal, Balance Disorder, Restless Legs Syndrome, Memory Impairment

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-21

Patient: female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-19

Patient: female

Reactions: Hypersexuality, Disturbance in Sexual Arousal

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-19

Patient:

Reactions: Restless Legs Syndrome

Drug(s) suspected as cause:
Mirapex



Possible Mirapex side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-06-18

Patient: 46 year old female, weighing 81.6 kg (179.6 pounds)

Reactions: Economic Problem, Family Stress, Impaired Work Ability, Condition Aggravated, Sleep Attacks, Compulsions, Suicidal Ideation, Pathological Gambling, Depression, Feeling Abnormal

Drug(s) suspected as cause:
Klonopin

Mirapex
    Dosage: 1-2 2xs a day 1 in a.m. - /1 in p other
    Indication: Restless Legs Syndrome
    Start date: 2011-04-05
    End date: 2012-06-15

Requip



Possible Mirapex side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-15

Patient: male, weighing 65.8 kg (144.7 pounds)

Reactions: Obsessive-Compulsive Disorder, Pain, Condition Aggravated, Compulsive Hoarding, Somnolence, Stress, Suicidal Ideation, Emotional Distress, Compulsive Shopping, Depression, Acute Myocardial Infarction

Drug(s) suspected as cause:
Mirapex
    Indication: Restless Legs Syndrome
    Start date: 2001-04-09
    End date: 2011-01-01

Mirapex
    Indication: Periodic Limb Movement Disorder

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