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Mirapex Side Effects

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Common Mirapex Side Effects


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

Pathological Gambling (733)
Emotional Distress (507)
Obsessive-compulsive Disorder (499)
Depression (411)
Pain (377)
Anxiety (282)
Compulsive Shopping (221)
Hypersexuality (161)
Stress (152)
Insomnia (145)
Hyperphagia (143)
Suicidal Ideation (124)
Somnolence (113)
Fear (102)
Weight Increased (99)
Economic Problem (92)
Hallucination (83)
Gambling (81)
Fatigue (80)
Nausea (74)

➢ 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.

Mirapex Side Effects Reported to FDA



Mirapex Side Effect Report#9993725
Dysphagia
This is a report of a 70-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: NA, who was treated with Mirapex La (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Dysphagia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirapex La treatment in male patients, resulting in Dysphagia side effect. The patient was hospitalized.
Mirapex Side Effect Report#9993011
Urinary Tract Infection, Pneumonia Viral, Kidney Infection, White Blood Cell Count Increased, Blood Potassium Increased, Off Label Use
This report suggests a potential Mirapex Urinary Tract Infection side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Mirapex (dosage: 0.5 Mg) starting 201112. After starting Mirapex the patient began experiencing various side effects, including: Urinary Tract Infection, Pneumonia Viral, Kidney Infection, White Blood Cell Count Increased, Blood Potassium Increased, Off Label UseAdditional drugs used concurrently:
  • Spiriva
The patient was hospitalized. Although Mirapex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Urinary Tract Infection, may still occur.
Mirapex Side Effect Report#9972220
Decreased Appetite, Dizziness
This Decreased Appetite problem was reported by a pharmacist from JP. A 72-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Mirapex La (dosage: 3 Mg). The following drugs were being taken at the same time:
  • Madopar
  • Methotrexate (0.8571 Mg)
  • Predonine (10 Mg)
  • Salazosulfapyridine (600 Mg)
  • Diclofenac Na (75 Mg)
  • Etizolam (0.5 Mg)
  • Gasrick D (20 Mg)
When using Mirapex La, the patient experienced the following unwanted symptoms/side effects: Decreased Appetite, DizzinessThe 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 Decreased Appetite, may become evident only after a product is in use by the general population.
Mirapex Side Effect Report#9969721
Migraine, Narcolepsy, Speech Disorder, Dysstasia, Vision Blurred, Headache, Unevaluable Event, Mental Impairment, Disorientation
This Migraine side effect was reported by a consumer or non-health professional from US. A 48-year-old female patient (weight:NA) experienced the following symptoms/conditions: restless legs syndrome.The patient was prescribed Mirapex (drug dosage: 0.25 Mg), which was initiated on
Jan 27, 2014. Concurrently used drugs: NA..After starting to take Mirapex the consumer reported adverse symptoms, such as: Migraine, Narcolepsy, Speech Disorder, Dysstasia, Vision Blurred, Headache, Unevaluable Event, Mental Impairment, DisorientationThese side effects may potentially be related to Mirapex.
Mirapex Side Effect Report#9964308
Insomnia
This is a report of a 63-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: restless legs syndrome, who was treated with Mirapex (dosage: NA, start time: 201312), combined with: NA. and developed a serious reaction and side effect(s): Insomnia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirapex treatment in female patients, resulting in Insomnia side effect.
Mirapex Side Effect Report#9955194
Cerebrovascular Accident, Restless Legs Syndrome, Hallucination, Insomnia, Hypokinesia, Dysarthria, Dry Mouth, Increased Upper Airway Secretion
This report suggests a potential Mirapex Cerebrovascular Accident side effect(s) that can have serious consequences. A 86-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: restless legs syndrome and used Mirapex (dosage: 0.125 Mg) starting 2002. After starting Mirapex the patient began experiencing various side effects, including: Cerebrovascular Accident, Restless Legs Syndrome, Hallucination, Insomnia, Hypokinesia, Dysarthria, Dry Mouth, Increased Upper Airway SecretionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Mirapex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cerebrovascular Accident, may still occur.
Mirapex Side Effect Report#9954434
Atrial Fibrillation, Cardiac Failure Congestive
This Atrial Fibrillation problem was reported by a consumer or non-health professional from US. A 77-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: restless legs syndrome. On 201401 this consumer started treatment with Mirapex (dosage: 1 Mg). The following drugs were being taken at the same time: NA. When using Mirapex, the patient experienced the following unwanted symptoms/side effects: Atrial Fibrillation, Cardiac Failure CongestiveThe 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 Atrial Fibrillation, may become evident only after a product is in use by the general population.
Mirapex Side Effect Report#9943035
Dehydration, Renal Failure, Loss Of Consciousness, Dyskinesia
This Dehydration side effect was reported by a health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: restless legs syndrome,parkinson^s disease.The patient was prescribed Mirapex (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Mirapex the consumer reported adverse symptoms, such as: Dehydration, Renal Failure, Loss Of Consciousness, DyskinesiaThese side effects may potentially be related to Mirapex. The patient was hospitalized.
Mirapex Side Effect Report#9939742
Obsessive-compulsive Disorder, Cardiac Disorder, Fluid Retention, Oedema, Mood Swings
This is a report of a 56-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: parkinson^s disease, who was treated with Mirapex (dosage: NA, start time:
Jul 10, 2013), combined with: NA. and developed a serious reaction and side effect(s): Obsessive-compulsive Disorder, Cardiac Disorder, Fluid Retention, Oedema, Mood Swings after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirapex treatment in male patients, resulting in Obsessive-compulsive Disorder side effect.
Mirapex Side Effect Report#9929546
Bronchitis, Overdose
This report suggests a potential Mirapex Bronchitis side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: restless legs syndrome,convulsion and used Mirapex (dosage: 0.75 Mg) starting 201308. After starting Mirapex the patient began experiencing various side effects, including: Bronchitis, OverdoseAdditional drugs used concurrently:
  • Depakote (2000 Mg)
  • Zonegran (500 Mg)
  • Klonopin (2 Mg)
The patient was hospitalized. Although Mirapex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bronchitis, may still occur.
Mirapex Side Effect Report#9929208
Somnolence, Grip Strength Decreased, Gait Disturbance
This Somnolence problem was reported by a consumer or non-health professional from US. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: restless legs syndrome. On NS this consumer started treatment with Mirapex (dosage: NA). The following drugs were being taken at the same time: NA. When using Mirapex, the patient experienced the following unwanted symptoms/side effects: Somnolence, Grip Strength Decreased, Gait DisturbanceAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Somnolence, may become evident only after a product is in use by the general population.
Mirapex Side Effect Report#9909850
Overdose, Somnolence
This Overdose side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease.The patient was prescribed Mirapex (drug dosage: 9 Mg), which was initiated on 2012. Concurrently used drugs: NA..After starting to take Mirapex the consumer reported adverse symptoms, such as: Overdose, SomnolenceThese side effects may potentially be related to Mirapex.
Mirapex Side Effect Report#9893442
Insomnia
This is a report of a 74-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: restless legs syndrome, who was treated with Mirapex (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Insomnia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirapex treatment in male patients, resulting in Insomnia side effect.
Mirapex Side Effect Report#9886242
Hallucination, Delusion, Confusional State
This report suggests a potential Mirapex La Hallucination side effect(s) that can have serious consequences. A 60-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: parkinson^s disease and used Mirapex La (dosage: 0.75 Mg) starting
Sep 19, 2013. After starting Mirapex La the patient began experiencing various side effects, including: Hallucination, Delusion, Confusional StateAdditional drugs used concurrently: NA.The patient was hospitalized. Although Mirapex La demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hallucination, may still occur.
Mirapex Side Effect Report#9879393
Restless Legs Syndrome, Syncope, Syncope
This Restless Legs Syndrome problem was reported by a consumer or non-health professional from US. A 73-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: restless legs syndrome. On
Dec 19, 2013 this consumer started treatment with Mirapex (dosage: 0.25 Mg). The following drugs were being taken at the same time: NA. When using Mirapex, the patient experienced the following unwanted symptoms/side effects: Restless Legs Syndrome, Syncope, SyncopeAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Restless Legs Syndrome, may become evident only after a product is in use by the general population.
Mirapex Side Effect Report#9868232
Cough, Gastrooesophageal Reflux Disease, Dyspnoea, Chest Discomfort, Weight Increased, Throat Irritation
This Cough side effect was reported by a consumer or non-health professional from US. A 54-year-old female patient (weight:NA) experienced the following symptoms/conditions: restless legs syndrome.The patient was prescribed Mirapex (drug dosage: NA), which was initiated on 2007. Concurrently used drugs: NA..After starting to take Mirapex the consumer reported adverse symptoms, such as: Cough, Gastrooesophageal Reflux Disease, Dyspnoea, Chest Discomfort, Weight Increased, Throat IrritationThese side effects may potentially be related to Mirapex.
Mirapex Side Effect Report#9853571
Pain In Extremity, Oedema
This is a report of a 84-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: parkinson^s disease, who was treated with Mirapex La (dosage: 0.375 Mg, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pain In Extremity, Oedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirapex La treatment in female patients, resulting in Pain In Extremity side effect. The patient was hospitalized.
Mirapex Side Effect Report#9827676
Parkinsonism
This report suggests a potential Mirapex La Parkinsonism side effect(s) that can have serious consequences. A 85-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: parkinson^s disease and used Mirapex La (dosage: NA) starting 201305. After starting Mirapex La the patient began experiencing various side effects, including: ParkinsonismAdditional drugs used concurrently:
  • Trerief
  • Bi-sifrol
The patient was hospitalized. Although Mirapex La demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Parkinsonism, may still occur.
Mirapex Side Effect Report#9804576
Tremor
This Tremor problem was reported by a consumer or non-health professional from US. A 59-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: parkinson^s disease. On
Mar 30, 2013 this consumer started treatment with Mirapex (dosage: 0.375 Mg). The following drugs were being taken at the same time: NA. When using Mirapex, the patient experienced the following unwanted symptoms/side effects: TremorAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tremor, may become evident only after a product is in use by the general population.
Mirapex Side Effect Report#9786621
Pneumonia Aspiration, Rheumatoid Arthritis, Renal Failure Acute, Depression, Sepsis, Hyperkalaemia, Clostridium Difficile Infection, Rhabdomyolysis
This Pneumonia Aspiration side effect was reported by a consumer or non-health professional from US. A 59-year-old female patient (weight:NA) experienced the following symptoms/conditions: restless legs syndrome.The patient was prescribed Mirapex (drug dosage: 1 Mg), which was initiated on 2009. Concurrently used drugs: NA..After starting to take Mirapex the consumer reported adverse symptoms, such as: Pneumonia Aspiration, Rheumatoid Arthritis, Renal Failure Acute, Depression, Sepsis, Hyperkalaemia, Clostridium Difficile Infection, RhabdomyolysisThese side effects may potentially be related to Mirapex. The patient was hospitalized.
Mirapex Side Effect Report#9785972
Local Swelling, Somnambulism, Fall, Contusion, Insomnia, Loss Of Consciousness, Off Label Use
This is a report of a 48-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: restless legs syndrome, who was treated with Mirapex (dosage: 0.75 Mg, start time: 201302), combined with: NA. and developed a serious reaction and side effect(s): Local Swelling, Somnambulism, Fall, Contusion, Insomnia, Loss Of Consciousness, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirapex treatment in female patients, resulting in Local Swelling side effect.
Mirapex Side Effect Report#9775195
Quality Of Life Decreased, Burning Sensation, Burning Sensation, Restless Legs Syndrome, Condition Aggravated, Paraesthesia, Hypoaesthesia, Hypoaesthesia, Micturition Urgency
This report suggests a potential Mirapex Quality Of Life Decreased side effect(s) that can have serious consequences. A 63-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: restless legs syndrome and used Mirapex (dosage: NA) starting
Dec 01, 2012. After starting Mirapex the patient began experiencing various side effects, including: Quality Of Life Decreased, Burning Sensation, Burning Sensation, Restless Legs Syndrome, Condition Aggravated, Paraesthesia, Hypoaesthesia, Hypoaesthesia, Micturition UrgencyAdditional drugs used concurrently: NA. Although Mirapex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Quality Of Life Decreased, may still occur.
Mirapex Side Effect Report#9773695
Pharyngeal Cancer, Pneumonia Aspiration
This Pharyngeal Cancer problem was reported by a pharmacist from JP. A 66-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 25, 2013 this consumer started treatment with Mirapex La (dosage: 4.5 Mg). The following drugs were being taken at the same time:
  • Opso / Morphine Hydrochloride Hydrate (30 Mg)
  • Neodopaston / Levodopa_carbidopa Hydrate (300 Mg)
  • Tryptanol / Amitriptyline Hydrochloride (30 Mg)
  • Limarmone / Limaprost Alfadex (15 Mcg)
When using Mirapex La, the patient experienced the following unwanted symptoms/side effects: Pharyngeal Cancer, Pneumonia AspirationThe 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 Pharyngeal Cancer, may become evident only after a product is in use by the general population.
Mirapex Side Effect Report#9773495
Hyponatraemia, Metabolic Encephalopathy
This Hyponatraemia side effect was reported by a physician from ES. A 86-year-old female patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease,hypertension.The patient was prescribed Mirapexin (drug dosage: 0.52 Mg), which was initiated on 201206. Concurrently used drugs:
  • Hidroclorotiazida (12.5 Mg)
  • Valsartan (360 Mg)
  • Metformina (850 Mg)
  • Levemir (18 U)
  • Prandin (6 Mg)
  • Prevencor (10 Mg)
  • Sinemet Plus (25 / 100 Mg)
.After starting to take Mirapexin the consumer reported adverse symptoms, such as: Hyponatraemia, Metabolic EncephalopathyThese side effects may potentially be related to Mirapexin. The patient was hospitalized.
Mirapex Side Effect Report#9757306
Intentional Overdose
This is a report of a 62-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Mirapex (dosage: 4.5 Mg, start time:
Nov 19, 2013), combined with: NA. and developed a serious reaction and side effect(s): Intentional Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mirapex treatment in female patients, resulting in Intentional Overdose side effect.


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The appearance of Mirapex 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 Mirapex Side Effects for Women?

Women Side EffectsReports
Pathological Gambling 330
Emotional Distress 239
Obsessive-compulsive Disorder 238
Pain 204
Depression 188
Anxiety 129
Compulsive Shopping 112
Insomnia 82
Somnolence 65
Stress 64

What are common Mirapex Side Effects for Men?

Men Side EffectsReports
Pathological Gambling 399
Emotional Distress 268
Obsessive-compulsive Disorder 258
Depression 223
Pain 171
Anxiety 153
Hypersexuality 139
Compulsive Shopping 109
Stress 88
Hyperphagia 84

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.

    Mirapex 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 Mirapex Side Effects

    Did You Have a Mirapex Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Mirapex for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Mirapex Safety Alerts, Active Ingredients, Usage Information

    NDC0597-0101
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameMirapex
    Namepramipexole dihydrochloride
    Dosage FormTABLET
    RouteORAL
    On market since20071001
    LabelerBoehringer Ingelheim Pharmaceuticals, Inc.
    Active Ingredient(s)PRAMIPEXOLE DIHYDROCHLORIDE
    Strength(s)0.75
    Unit(s)mg/1
    Pharma ClassDopamine Agonists [MoA],Nonergot Dopamine Agonist [EPC]

    More About Mirapex

    Side Effects reported to FDA: 1922

    Mirapex safety alerts: 2012

    Reported deaths: 54

    Reported hospitalizations: 421

    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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