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Pramipexole Side Effects

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Common Pramipexole Side Effects


The most commonly reported Pramipexole side effects (click to view or check a box to report):

Pathological Gambling (56)
Fall (44)
Hallucination (37)
Impulse-control Disorder (35)
Depression (32)
Condition Aggravated (31)
Somnolence (31)
Dyskinesia (30)
Hypersexuality (30)
Dizziness (29)
Anxiety (28)
Restless Legs Syndrome (27)
Dyspnoea (26)
Hallucination, Visual (25)
Psychotic Disorder (24)
Abnormal Behaviour (23)
Oedema Peripheral (23)
Obsessive-compulsive Disorder (22)
Gait Disturbance (22)
Insomnia (22)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Pramipexole Side Effects Reported to FDA



Pramipexole Side Effect Report#9995393
Obsessive-compulsive Disorder, Pathological Gambling, Cerebrovascular Accident, Economic Problem
This is a report of a 74-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: restless legs syndrome, who was treated with Pramipexole (pramipexole) (dosage: NA, start time:
Sep 01, 2010), combined with: NA. and developed a serious reaction and side effect(s): Obsessive-compulsive Disorder, Pathological Gambling, Cerebrovascular Accident, Economic Problem after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pramipexole (pramipexole) treatment in female patients, resulting in Obsessive-compulsive Disorder side effect. The patient was hospitalized and became disabled.
Pramipexole Side Effect Report#9990698
Cerebrovascular Accident, Obsessive-compulsive Disorder, Pathological Gambling
This report suggests a potential Pramipexole Cerebrovascular Accident side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: restless legs syndrome and used Pramipexole (dosage: Unk) starting
Sep 01, 2010. After starting Pramipexole the patient began experiencing various side effects, including: Cerebrovascular Accident, Obsessive-compulsive Disorder, Pathological GamblingAdditional drugs used concurrently: NA.The patient was hospitalized and became disabled. Although Pramipexole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cerebrovascular Accident, may still occur.
Pramipexole Side Effect Report#9942401
Movement Disorder, Speech Disorder, Eating Disorder, Salivary Hypersecretion, Sedation, Fall
This Movement Disorder problem was reported by a consumer or non-health professional from DE. A 90-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Pramipexole (dosage: NA). The following drugs were being taken at the same time:
  • Risperdal
  • Zyprexa
  • Valdoxan
  • Diazepam (45 Anz)
  • Levodopa
When using Pramipexole, the patient experienced the following unwanted symptoms/side effects: Movement Disorder, Speech Disorder, Eating Disorder, Salivary Hypersecretion, Sedation, FallThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Movement Disorder, may become evident only after a product is in use by the general population.
Pramipexole Side Effect Report#9940567
Dyskinesia
This Dyskinesia side effect was reported by a physician from TR. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: restless legs syndrome,off label use,diabetic neuropathy.The patient was prescribed Pramipexole (drug dosage: 3 X 0.125mg), which was initiated on NS. Concurrently used drugs: NA..After starting to take Pramipexole the consumer reported adverse symptoms, such as: DyskinesiaThese side effects may potentially be related to Pramipexole.
Pramipexole Side Effect Report#9924439
Insomnia, Hallucination, Arthralgia, Headache, Arthralgia, Alopecia, Visual Impairment, Fatigue, Rhinorrhoea
This is a report of a 71-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: muscle spasms, who was treated with Pramipexole (dosage: Once Daily, start time:
Sep 01, 2013), combined with: NA. and developed a serious reaction and side effect(s): Insomnia, Hallucination, Arthralgia, Headache, Arthralgia, Alopecia, Visual Impairment, Fatigue, Rhinorrhoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pramipexole treatment in female patients, resulting in Insomnia side effect.
Pramipexole Side Effect Report#9893811
Parkinsonism Hyperpyrexia Syndrome, Altered State Of Consciousness, Hypertonia, Food Interaction, Hallucination
This report suggests a potential Pramipexole Parkinsonism Hyperpyrexia Syndrome side effect(s) that can have serious consequences. A 81-year-old male patient (weight: NA) from Country Not Specified was diagnosed with the following symptoms/conditions: parkinson^s disease and used Pramipexole (dosage: 2.1 Mg) starting NS. After starting Pramipexole the patient began experiencing various side effects, including: Parkinsonism Hyperpyrexia Syndrome, Altered State Of Consciousness, Hypertonia, Food Interaction, HallucinationAdditional drugs used concurrently: NA. Although Pramipexole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Parkinsonism Hyperpyrexia Syndrome, may still occur.
Pramipexole Side Effect Report#9889226
Compulsive Shopping, Dopamine Dysregulation Syndrome, Stereotypy
This Compulsive Shopping problem was reported by a health professional from Country Not Specified. A 61-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: parkinson^s disease. On NS this consumer started treatment with Pramipexole (dosage: NA). The following drugs were being taken at the same time:
  • L-dopa (800 Mg)
  • Entacapone
When using Pramipexole, the patient experienced the following unwanted symptoms/side effects: Compulsive Shopping, Dopamine Dysregulation Syndrome, StereotypyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Compulsive Shopping, may become evident only after a product is in use by the general population.
Pramipexole Side Effect Report#9889224
Binge Eating, Stereotypy
This Binge Eating side effect was reported by a health professional from Country Not Specified. A 63-year-old male patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease.The patient was prescribed Pramipexole (drug dosage: 2.64 Mg), which was initiated on NS. Concurrently used drugs:
  • L-dopa (950 Mg)
  • Rasagiline
  • Entacapone
.After starting to take Pramipexole the consumer reported adverse symptoms, such as: Binge Eating, StereotypyThese side effects may potentially be related to Pramipexole.
Pramipexole Side Effect Report#9889126
Pathological Gambling, Hypersexuality, Binge Eating, Dopamine Dysregulation Syndrome
This is a report of a 56-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: parkinson^s disease, who was treated with Pramipexole (dosage: NA, start time: NS), combined with:
  • L-dopa (1550 Mg)
  • Rasagiline
  • Clonazepam
and developed a serious reaction and side effect(s): Pathological Gambling, Hypersexuality, Binge Eating, Dopamine Dysregulation Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pramipexole treatment in male patients, resulting in Pathological Gambling side effect.
Pramipexole Side Effect Report#9887501
Cough, Chest Discomfort, Dyspnoea, Quality Of Life Decreased, Weight Increased
This report suggests a potential Pramipexole Cough side effect(s) that can have serious consequences. A 54-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: restless legs syndrome,gastrooesophageal reflux disease,multiple allergies and used Pramipexole (dosage: 1 Df, Hs) starting 2007. After starting Pramipexole the patient began experiencing various side effects, including: Cough, Chest Discomfort, Dyspnoea, Quality Of Life Decreased, Weight IncreasedAdditional drugs used concurrently:
  • Omeprazole (1 Df, Qd)
  • Claritin /00917501/ (Unk)
  • Vitamin D /00107901/ (Unk)
Although Pramipexole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cough, may still occur.
Pramipexole Side Effect Report#9883216
Pleurothotonus
This Pleurothotonus problem was reported by a health professional from TR. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: parkinson^s disease. On 2009 this consumer started treatment with Pramipexole (dosage: 4.5mg). The following drugs were being taken at the same time:
  • Rasagiline (1mg)
  • Sinemet (400mg; Then 1g/day)
  • Sinemet (1g/day)
When using Pramipexole, the patient experienced the following unwanted symptoms/side effects: PleurothotonusThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pleurothotonus, may become evident only after a product is in use by the general population.
Pramipexole Side Effect Report#9868589
Pleurothotonus, Gait Disturbance, Posture Abnormal, Balance Disorder
This Pleurothotonus side effect was reported by a health professional from TR. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease.The patient was prescribed Pramipexole (drug dosage: 4.5 Mg, Unk), which was initiated on 2010. Concurrently used drugs: NA..After starting to take Pramipexole the consumer reported adverse symptoms, such as: Pleurothotonus, Gait Disturbance, Posture Abnormal, Balance DisorderThese side effects may potentially be related to Pramipexole. The patient was hospitalized.
Pramipexole Side Effect Report#9867118
Cough, Dyspnoea, Somnolence
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: restless legs syndrome, who was treated with Pramipexole Dihydrochloride (dosage: .25mg 1 Tablet At Bedtime Once At Bedtime Mouth, start time: 2007), combined with:
  • Omeprazole
  • Azalastine
and developed a serious reaction and side effect(s): Cough, Dyspnoea, Somnolence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pramipexole Dihydrochloride treatment in female patients, resulting in Cough side effect.
Pramipexole Side Effect Report#9866983
Cardiac Failure Congestive, Restless Legs Syndrome, Condition Aggravated
This report suggests a potential Pramipexole Cardiac Failure Congestive side effect(s) that can have serious consequences. A 49-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: restless legs syndrome and used Pramipexole (dosage: Taken By Mouth) starting NS. After starting Pramipexole the patient began experiencing various side effects, including: Cardiac Failure Congestive, Restless Legs Syndrome, Condition AggravatedAdditional drugs used concurrently: NA.The patient was hospitalized. Although Pramipexole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Failure Congestive, may still occur.
Pramipexole Side Effect Report#9826042
Coordination Abnormal, Gait Disturbance, Dizziness, Feeling Abnormal, Listless, Fatigue, Product Substitution Issue
This Coordination Abnormal problem was reported by a health professional from GB. A 76-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 22, 2013 this consumer started treatment with Pramipexole (dosage: 2 Df, Tid, Oral). The following drugs were being taken at the same time: NA. When using Pramipexole, the patient experienced the following unwanted symptoms/side effects: Coordination Abnormal, Gait Disturbance, Dizziness, Feeling Abnormal, Listless, Fatigue, Product Substitution IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Coordination Abnormal, may become evident only after a product is in use by the general population.
Pramipexole Side Effect Report#9826031
Cardiac Failure, Dyspnoea, Fluid Retention, Pulmonary Oedema
This Cardiac Failure side effect was reported by a health professional from GB. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease.The patient was prescribed Pramipexole (drug dosage: NA), which was initiated on
Jan 06, 2012. Concurrently used drugs:
  • Aspirin (acetylsalicylic Acid)
  • Bisoprolol Fumarate
  • Furosemide (furosemide)
  • Pravastatin (pravastatin)
  • Ramipril (ramipril)
.After starting to take Pramipexole the consumer reported adverse symptoms, such as: Cardiac Failure, Dyspnoea, Fluid Retention, Pulmonary OedemaThese side effects may potentially be related to Pramipexole.
Pramipexole Side Effect Report#9826015
Personality Change, Obsessive-compulsive Personality Disorder, Impulsive Behaviour, Impulse-control Disorder
This is a report of a 56-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: parkinson^s disease, who was treated with Pramipexole (dosage: NA, start time: NS), combined with:
  • Rasagiline (rasagiline)
and developed a serious reaction and side effect(s): Personality Change, Obsessive-compulsive Personality Disorder, Impulsive Behaviour, Impulse-control Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pramipexole treatment in male patients, resulting in Personality Change side effect. The patient was hospitalized.
Pramipexole Side Effect Report#9822310
Acute Psychosis, Alcohol Interaction
This report suggests a potential Pramipexole Acute Psychosis side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: restless legs syndrome and used Pramipexole (dosage: NA) starting NS. After starting Pramipexole the patient began experiencing various side effects, including: Acute Psychosis, Alcohol InteractionAdditional drugs used concurrently: NA. Although Pramipexole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acute Psychosis, may still occur.
Pramipexole Side Effect Report#9820543
Impulse-control Disorder, Pathological Gambling, Food Craving, Weight Increased, Memory Impairment
This Impulse-control Disorder problem was reported by a health professional from Country Not Specified. A 52-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: parkinson^s disease. On NS this consumer started treatment with Pramipexole (dosage: NA). The following drugs were being taken at the same time:
  • Amantadine
  • Benztropine
  • Levodopa-carbidopa
When using Pramipexole, the patient experienced the following unwanted symptoms/side effects: Impulse-control Disorder, Pathological Gambling, Food Craving, Weight Increased, Memory ImpairmentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Impulse-control Disorder, may become evident only after a product is in use by the general population.
Pramipexole Side Effect Report#9818155
Memory Impairment, Apraxia, Aphasia, Impulse-control Disorder, Pathological Gambling, Compulsive Shopping, Disinhibition, Gambling, Euphoric Mood
This Memory Impairment side effect was reported by a health professional from CL. A 52-year-old male patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease.The patient was prescribed Pramipexole (drug dosage: 3 Mg, Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Pramipexole the consumer reported adverse symptoms, such as: Memory Impairment, Apraxia, Aphasia, Impulse-control Disorder, Pathological Gambling, Compulsive Shopping, Disinhibition, Gambling, Euphoric MoodThese side effects may potentially be related to Pramipexole.
Pramipexole Side Effect Report#9817303
Acute Psychosis, Alcohol Interaction
This is a report of a 52-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: restless legs syndrome, who was treated with Pramipexole (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Acute Psychosis, Alcohol Interaction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pramipexole treatment in female patients, resulting in Acute Psychosis side effect.
Pramipexole Side Effect Report#9813357
Psychotic Disorder
This report suggests a potential Pramipexole Psychotic Disorder side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: restless legs syndrome and used Pramipexole (dosage: Oral) starting
Nov 30, 2013. After starting Pramipexole the patient began experiencing various side effects, including: Psychotic DisorderAdditional drugs used concurrently: NA. Although Pramipexole demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Psychotic Disorder, may still occur.
Pramipexole Side Effect Report#9738507
Obsessive-compulsive Disorder
This Obsessive-compulsive Disorder problem was reported by a physician from IT. A 68-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: parkinson^s disease. On NS this consumer started treatment with Pramipexole (dosage: Titrated To 1mg Three Times Daily). The following drugs were being taken at the same time:
  • Carbidopa + Levodopa (Titrated To 300mg Daily)
When using Pramipexole, the patient experienced the following unwanted symptoms/side effects: Obsessive-compulsive DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Obsessive-compulsive Disorder, may become evident only after a product is in use by the general population.
Pramipexole Side Effect Report#9714392
Tremor, Restless Legs Syndrome, Dystonia, Somnolence, Balance Disorder
This Tremor side effect was reported by a health professional from Country Not Specified. A 78-year-old male patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease.The patient was prescribed Pramipexole (drug dosage: 0.75 Mg), which was initiated on NS. Concurrently used drugs:
  • Carbidopa W/levodopa (450 Mg)
  • Clonazepam (0.5 Mg)
.After starting to take Pramipexole the consumer reported adverse symptoms, such as: Tremor, Restless Legs Syndrome, Dystonia, Somnolence, Balance DisorderThese side effects may potentially be related to Pramipexole.
Pramipexole Side Effect Report#9679083
Dyskinesia, Sleep Apnoea Syndrome, Somnolence, Gait Disturbance
This is a report of a 60-year-old male patient (weight: NA) from Country Not Specified, suffering from the following health symptoms/conditions: parkinson^s disease, who was treated with Pramipexole (dosage: 2.1 Mg, start time: NS), combined with:
  • Madopar (800 Mg)
and developed a serious reaction and side effect(s): Dyskinesia, Sleep Apnoea Syndrome, Somnolence, Gait Disturbance after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pramipexole treatment in male patients, resulting in Dyskinesia side effect.


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The appearance of Pramipexole on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Pramipexole Side Effects for Women?

Women Side EffectsReports
Fall 31
Condition Aggravated 17
Dyspnoea 17
Hallucination 17
Pathological Gambling 15
Restless Legs Syndrome 15
Vomiting 15
Confusional State 14
Dyskinesia 14
Compulsive Shopping 13

What are common Pramipexole Side Effects for Men?

Men Side EffectsReports
Pathological Gambling 39
Hypersexuality 28
Depression 27
Impulse-control Disorder 26
Anxiety 22
Hallucination 20
Psychotic Disorder 20
Somnolence 18
Abnormal Behaviour 17
Dizziness 17

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Pramipexole reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Pramipexole Side Effects

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    How Effective is Pramipexole for You?

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    Pramipexole Safety Alerts, Active Ingredients, Usage Information

    NDC0179-0083
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NamePRAMIPEXOLE DIHYDROCHLORIDE
    NamePRAMIPEXOLE DIHYDROCHLORIDE
    Dosage FormTABLET
    RouteORAL
    On market since20110215
    LabelerKAISER FOUNDATION HOSPITALS
    Active Ingredient(s)PRAMIPEXOLE DIHYDROCHLORIDE
    Strength(s)0.125
    Unit(s)mg/1
    Pharma ClassDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]

    More About Pramipexole

    Side Effects reported to FDA: 659

    Pramipexole safety alerts: 2012

    Reported deaths: 25

    Reported hospitalizations: 210

    Mirapex (pramipexole): Drug Safety Communication - Ongoing Safety Review, Possible Risk of Heart Failure

     

    [Posted 09/19/2012]

    AUDIENCE: Neurology

    ISSUE: FDA notified healthcare profesionals about a possible increased risk of heart failure with Mirapex (pramipexole). Results of recent studies suggest a potential risk of heart failure that needs further review of available data. Because of the study limitations, FDA is not able to determine whether Mirapex increases the risk of heart failure. FDA is continuing to work with the manufacturer to clarify further the risk of heart failure with Mirapex and will update the public when more information is available.

    FDA evaluated a pooled analysis of randomized clinical trials and found that heart failure was more frequent with Mirapex than with placebo; however, these results were not statistically significant. FDA also evaluated two epidemiologic studies that suggested an increased risk of new onset of heart failure with Mirapex use. However, study limitations make it difficult to determine whether excess heart failure was related to Mirapex use or other influencing factors (see FDA Drug Safety Communication Data Summary for a detailed discussion of the studies).

    BACKGROUND: Mirapex (pramipexole) is a prescription medicine used to treat the signs and symptoms of Parkinson's disease and moderate to severe symptoms of primary restless legs syndrome, in a class of medicines called dopamine agonists.

    RECOMMENDATION: At this time, FDA has not concluded that Mirapex increases the risk of heart failure. Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Mirapex. Patients should continue to take their Mirapex as directed and should contact their health care professional if they have any questions or concerns.

    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [09/19/2012 - Drug Safety Communication - FDA]
     

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