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Index of reports
> Serious Reactions (28)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Mirapex (Pramipexole) serious reactions. The selected reports were submitted to the FDA during the sample period of about a year.
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:
Sinemet
Dosage: 2 df, bid
Administration route: Oral
Indication: Parkinson's Disease
Start date: 2007-01-01
Mirapex
Dosage: 1 df, qd
Other drugs received by patient: Simvastatin; Metformin; Diovan; Lidoderm; Prevacid; Vicodin; Levothyroxine Sodium; Cogentin
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 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 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 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:
Requip
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
Klonopin
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
Possible Mirapex side effects in 49 year old male
Reported by a physician from United States on 2012-05-23
Patient: 49 year old male
Reactions: Osteonecrosis, Arthralgia
Drug(s) suspected as cause:
Mirapex
Possible Mirapex side effects in
Reported by a consumer/non-health professional from Canada on 2012-05-17
Patient:
Reactions: Renal Transplant, Quality of Life Decreased, Suicide Attempt, Compulsive Shopping, Gambling
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mirapex
Indication: Restless Legs Syndrome
End date: 2011-05-15
Mirapex
End date: 2011-05-15
Possible Mirapex side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-14
Patient: male, weighing 93.0 kg (204.6 pounds)
Reactions: Obsessive-Compulsive Disorder, Somnolence
Drug(s) suspected as cause:
Mirapex
Possible Mirapex side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-03
Patient: female, weighing 70.8 kg (155.8 pounds)
Reactions: Weight Increased, Insomnia, Drug Ineffective FOR Unapproved Indication, Drug Interaction, Depression, Crying
Drug(s) suspected as cause:
Mirapex
Dosage: .375 milligram;
Administration route: Oral
Indication: Restless Legs Syndrome
Start date: 2010-12-01
Ambien
Dosage: 10 milligram;
Administration route: Oral
Indication: Sleep Disorder
Seroquel XR
Dosage: 150 milligram;
Administration route: Oral
Indication: Sleep Disorder
Start date: 2010-10-01
Adderall 5
Dosage: 60 milligram;
Administration route: Oral
Indication: Attention Deficit / Hyperactivity Disorder
Start date: 2010-10-01
Other drugs received by patient possibly interacting with the suspect drug:
Nuvigil
Dosage: 150 milligram;
Administration route: Oral
Indication: Bipolar I Disorder
Start date: 2011-04-04
End date: 2011-04-18
Nuvigil
Dosage: 250 milligram;
Administration route: Oral
Start date: 2011-04-19
End date: 2011-04-23
Possible Mirapex side effects in female
Reported by a lawyer from United States on 2012-05-01
Patient: female, weighing 74.4 kg (163.6 pounds)
Reactions: Agitation, Drug Ineffective, Folliculitis, Bipolar II Disorder, Obesity, Depression, Sinusitis, Arteriosclerosis, Migraine, Libido Decreased, Stress, Seborrhoea, Anxiety, Cholelithiasis, Hysterectomy, Affective Disorder, Insomnia, Withdrawal Syndrome, Memory Impairment, Feeling Abnormal, Respiratory Tract Infection, Salpingo-Oophorectomy Bilateral
Drug(s) suspected as cause:
Zoloft
Dosage: 50 mg, 1x/day
Start date: 1999-06-15
Effexor
Dosage: 75 mg, 1x/day
Indication: Anxiety
Start date: 2006-10-17
Zoloft
Dosage: 25mg, a day for seven days
Indication: Depression
Start date: 1999-03-01
End date: 1999-03-07
Xanax
Dosage: 0.5 mg, every 8 hours
Start date: 2002-11-19
Wellbutrin
Dosage: 200mg, one daily
Indication: Depression
Start date: 2004-05-18
End date: 2004-05-20
Lortab
Dosage: 7.5/500 one every 6-8 hours as needed
Indication: Headache
Start date: 2004-01-01
End date: 2005-02-02
Zoloft
Dosage: 50 mg, 2x/day
Start date: 1999-12-06
Xanax
Dosage: 0.25 mg, 2x/day
Indication: Anxiety
Calan
Dosage: unk
Indication: Migraine
Wellbutrin
Dosage: 150 mg, 1x/day
Indication: Affective Disorder
Start date: 2004-11-11
Topamax
Dosage: 25 mg, at night for 17 days
Start date: 2004-05-04
Midrin
Dosage: two capsules at start of migraine
Indication: Migraine
Start date: 2011-11-11
Excedrin (Migraine)
Indication: Migraine
Zoloft
Dosage: 75 mg, 1x/day
Indication: Adjustment Disorder
Start date: 1999-06-01
Effexor
Dosage: 37.5 mg, 1x/day
Indication: Depression
Start date: 2006-10-10
End date: 2006-10-16
Lunesta
Dosage: unk
Indication: Sleep Disorder
Start date: 2009-06-01
Topamax
Dosage: 25 mg, x7days in the morning
Start date: 2005-02-16
Mirapex
Indication: Sleep Disorder
Paxil
Dosage: 20 mg, 1x/day
Start date: 1999-01-01
Zoloft
Dosage: 20 mg, 1x/day for 4 weeks
Zoloft
Dosage: 100 mg, for 6 months
Start date: 2004-06-23
Ultram
Dosage: 50 mg, as needed, every 8 hours
Indication: Headache
Start date: 2004-11-17
Wellbutrin
Dosage: 300 mg, unk
Start date: 2004-11-17
Zoloft
Dosage: 50mg, for four weeks
Indication: Affective Disorder
Start date: 1999-03-08
Zoloft
Dosage: 100 mg, 1x/day
Start date: 1999-07-27
Zoloft
Dosage: 75 mg, unk
Start date: 2002-11-19
Zoloft
Dosage: 50 mg, unk
Administration route: Oral
Start date: 2002-05-20
Inderal LA
Dosage: 60mg 1 at night
Topamax
Dosage: 25, twice a day for seven days
Indication: Migraine
Start date: 2005-02-02
Lortab
Dosage: 5/500 one every 8 hours as needed
Start date: 2005-01-18
End date: 2005-02-02
Cymbalta
Dosage: 30 mg, 1x/day
Indication: Insomnia
Paxil
Dosage: 10 mg, 1x/day
Administration route: Oral
Start date: 1999-06-01
Elavil
Dosage: unk
Indication: Migraine
Lexapro
Dosage: 10 mg, unk
Start date: 2004-06-23
Topamax
Dosage: 50 mg and 25 mg in the morning for 7 days
Start date: 2005-02-09
Motrin
Indication: Migraine
Other drugs received by patient: Ortho-Novum
Possible Mirapex side effects in 91 year old female
Reported by a physician from Japan on 2012-04-25
Patient: 91 year old female
Reactions: Night Sweats, Diarrhoea, Dehydration, Marasmus, Respiratory Depression, Altered State of Consciousness
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mirapex
Administration route: Oral
Indication: Muscle Rigidity
Start date: 2012-01-04
End date: 2012-01-25
Mirapex
Administration route: Oral
Start date: 2012-02-25
End date: 2012-03-03
Mirapex
Dosage: 0.375 mg
Administration route: Oral
Start date: 2012-01-26
End date: 2012-02-24
Other drugs received by patient: Lasix; Levothyroxine Sodium; Aspirin
Possible Mirapex side effects in 91 year old female
Reported by a physician from Japan on 2012-04-20
Patient: 91 year old female
Reactions: Night Sweats, Diarrhoea, Dehydration, Respiratory Depression, Altered State of Consciousness
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mirapex
Administration route: Oral
Indication: Muscle Rigidity
Start date: 2012-01-04
End date: 2012-01-25
Mirapex
Dosage: 0.375 mg
Administration route: Oral
Start date: 2012-01-26
End date: 2012-02-24
Mirapex
Administration route: Oral
Start date: 2012-02-25
End date: 2012-03-03
Other drugs received by patient: Lasix; Aspirin; Levothyroxine Sodium
Possible Mirapex side effects in 91 year old female
Reported by a physician from Japan on 2012-03-30
Patient: 91 year old female
Reactions: Night Sweats, Diarrhoea, Dehydration, Respiratory Depression, Altered State of Consciousness
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Mirapex
Administration route: Oral
Start date: 2012-01-26
End date: 2012-02-24
Mirapex
Administration route: Oral
Start date: 2012-02-25
End date: 2012-03-03
Mirapex
Administration route: Oral
Indication: Muscle Rigidity
Start date: 2012-01-04
End date: 2012-01-25
Other drugs received by patient: Lasix; Aspirin; Levothyroxine Sodium
Possible Mirapex side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-02
Patient: female
Reactions: Joint Swelling, Skin Ulcer, Stress Fracture, Myocardial Infarction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mirapex
Other drugs received by patient: Metoprolol Succinate; Zetia; Synthroid; Furosemide; Hydrochlorothiazide; Losartan Potassium; Potassium Chloride
Possible Mirapex side effects in 46 year old male
Reported by a consumer/non-health professional from Canada on 2012-03-01
Patient: 46 year old male
Reactions: Mood Altered, Pathological Gambling, Feeling Abnormal, Suicidal Ideation
Drug(s) suspected as cause:
Mirapex
Other drugs received by patient: Gabapentin; Gabapentin; Effexor XR; Folic Acid
Possible Mirapex side effects in 67 year old male
Reported by a consumer/non-health professional from Canada on 2012-02-21
Patient: 67 year old male
Reactions: Balance Disorder, Walking Disability
Drug(s) suspected as cause:
Mirapex
Dosage: 0.75 mg
Administration route: Oral
Mirapex
Dosage: 1.5 mg
Administration route: Oral
Mirapex
Dosage: 0.75 mg
Administration route: Oral
Other drugs received by patient: Glyburide; Metformin HCL
Possible Mirapex side effects in 49 year old female
Reported by a consumer/non-health professional from Canada on 2012-02-21
Patient: 49 year old female, weighing 89.8 kg (197.6 pounds)
Reactions: Asthma, Insomnia, Pathological Gambling, Condition Aggravated, Compulsions
Drug(s) suspected as cause:
Mirapex
Dosage: 0.25 mg
Administration route: Oral
Requip
Dosage: 0.25 mg
Administration route: Oral
Other drugs received by patient: Asthma Medications
Possible Mirapex side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-09
Patient: male
Reactions: Sexual Activity Increased, Somnolence, Erectile Dysfunction, Weight Increased, Fatigue, Pathological Gambling, Oedema Peripheral, Depression, Psychomotor Hyperactivity, Abnormal Behaviour, Anxiety, Therapeutic Response Decreased, Illogical Thinking, Hyperphagia, Paradoxical Drug Reaction, Insomnia, Libido Increased
Drug(s) suspected as cause:
Mirapex
Indication: Parkinson's Disease
Start date: 1997-11-10
End date: 2003-08-01
Mirapex
Dosage: 2.25 mg
Start date: 2003-09-01
Other drugs received by patient: Sinemet CR
Possible Mirapex side effects in female
Reported by a lawyer from United States on 2011-12-07
Patient: female, weighing 74.4 kg (163.6 pounds)
Reactions: Agitation, Drug Ineffective, Folliculitis, Bipolar II Disorder, Obesity, Depression, Arteriosclerosis, Sinusitis, Migraine, Libido Decreased, Stress, Seborrhoea, Hysterectomy, Cholelithiasis, Anxiety, Affective Disorder, Insomnia, Withdrawal Syndrome, Memory Impairment, Feeling Abnormal, Respiratory Tract Infection, Salpingo-Oophorectomy Bilateral
Drug(s) suspected as cause:
Zoloft
Dosage: 75 mg, 1x/day
Indication: Adjustment Disorder
Start date: 1999-06-01
Zoloft
Dosage: 20 mg, 1x/day for 4 weeks
Zoloft
Dosage: 100 mg, for 6 months
Start date: 2004-06-23
Effexor
Dosage: 75 mg, 1x/day
Indication: Anxiety
Start date: 2006-10-17
Topamax
Dosage: 25, twice a day for seven days
Indication: Migraine
Start date: 2005-02-02
Topamax
Dosage: 25 mg, x7days in the morning
Start date: 2005-02-16
Mirapex
Indication: Sleep Disorder
Propranolol
Topamax
Dosage: 25 mg, at night for 17 days
Start date: 2004-05-04
Cymbalta
Dosage: 30 mg, 1x/day
Indication: Insomnia
Motrin
Indication: Migraine
Wellbutrin
Dosage: 200mg, one daily
Indication: Depression
Start date: 2004-05-18
End date: 2004-05-20
Wellbutrin
Dosage: 300 mg, unk
Start date: 2004-11-17
Paxil
Dosage: 20 mg, 1x/day
Start date: 1999-01-01
Zoloft
Dosage: 75 mg, unk
Start date: 2002-11-19
Xanax
Dosage: 0.5 mg, every 8 hours
Start date: 2002-11-19
Effexor
Dosage: 37.5 mg, 1x/day
Indication: Depression
Start date: 2006-10-10
End date: 2006-10-16
Zoloft
Dosage: 50 mg, 1x/day
Start date: 1999-06-15
Zoloft
Dosage: 50 mg, unk
Administration route: Oral
Start date: 2002-05-20
Lexapro
Dosage: 10 mg, unk
Start date: 2004-06-23
Lortab
Dosage: 7.5/500 one every 6-8 hours as needed
Indication: Headache
Start date: 2004-01-01
End date: 2005-02-02
Zoloft
Dosage: 50mg, for four weeks
Indication: Affective Disorder
Start date: 1999-03-08
Zoloft
Dosage: 100 mg, 1x/day
Start date: 1999-07-27
Zoloft
Dosage: 50 mg, 2x/day
Start date: 1999-12-06
Ultram
Dosage: 50 mg, as needed, every 8 hours
Indication: Headache
Start date: 2004-11-17
Lunesta
Dosage: unk
Indication: Sleep Disorder
Start date: 2009-06-01
Excedrin (Migraine)
Indication: Migraine
Zoloft
Dosage: 25mg, a day for seven days
Indication: Depression
Start date: 1999-03-01
End date: 1999-03-07
Xanax
Dosage: 0.25 mg, 2x/day
Indication: Anxiety
Calan
Dosage: unk
Indication: Migraine
Wellbutrin
Dosage: 150 mg, 1x/day
Indication: Affective Disorder
Start date: 2004-11-11
Paxil
Dosage: 10 mg, 1x/day
Administration route: Oral
Start date: 1999-06-01
Elavil
Dosage: unk
Indication: Migraine
Topamax
Dosage: 50 mg and 25 mg in the morning for 7 days
Start date: 2005-02-09
Lortab
Dosage: 5/500 one every 8 hours as needed
Start date: 2005-01-18
End date: 2005-02-02
Midrin
Dosage: two capsules at start of migraine
Indication: Migraine
Start date: 2011-11-11
Other drugs received by patient: Ortho-Novum
Possible Mirapex side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-29
Patient: female, weighing 77.1 kg (169.6 pounds)
Reactions: Pain, Parkinson's Disease, Pyrexia, Hyperhidrosis, Fall, Suicidal Ideation, Road Traffic Accident, Hot Flush, Palpitations, Multiple Injuries, Muscle Spasms, Nightmare, Cellulitis, Frostbite, Sleep Attacks, HIP Fracture, Withdrawal Syndrome
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Mirapex
Other drugs received by patient: Mirapex ER
Possible Mirapex side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-15
Patient: female
Reactions: Migraine, Balance Disorder, Urinary Tract Infection, Dehydration, Fall, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Loratadine
Dosage: 10 mg, unk
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Lexapro
Dosage: 20 mg, qd
Ambien
Dosage: 5 mg, qd
Mirapex
Dosage: 0.75 mg, (0.25 mg and 0.5 mg)
Nitrofurantoin
Dosage: 100 mg, bid
Lyrica
Dosage: 100 mg, tid
Singulair
Dosage: 10 mg, unk
Adderall 5
Dosage: 10 mg, bid
Possible Mirapex side effects in
Reported by a consumer/non-health professional from Canada on 2011-11-15
Patient:
Reactions: Renal Transplant, Quality of Life Decreased, Suicide Attempt, Compulsive Shopping, Gambling
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mirapex
Possible Mirapex side effects in female
Reported by a individual with unspecified qualification from United States on 2011-11-15
Patient: female
Reactions: Migraine, Balance Disorder, Dehydration, Urinary Tract Infection, Fall, Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Loratadine
Dosage: 10 mg, unk
Ambien
Dosage: 5 mg, qd
Singulair
Dosage: 10 mg, unk
Lyrica
Dosage: 100 mg, tid
Adderall 5
Dosage: 10 mg, bid
Nitrofurantoin
Dosage: 100 mg, bid
Mirapex
Dosage: 0.75 mg, (0.25 mg and 0.5 mg)
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Lexapro
Dosage: 20 mg, qd
Possible Mirapex side effects in female
Reported by a individual with unspecified qualification from United States on 2011-11-11
Patient: female, weighing 69.0 kg (151.8 pounds)
Reactions: Nausea, Diarrhoea, Incorrect Dose Administered, Headache, Somnolence, Influenza Like Illness
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qod
Administration route: Oral
End date: 2011-10-01
Mirapex
Dosage: 0.25 at 4pm and 0.5 at 8pm
Administration route: Oral
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Relapsing-Remitting Multiple Sclerosis
Start date: 2011-09-01
Other drugs received by patient: Hygroton; Fenofibrate; Janumet; Zocor; Zestril; Aspirin; Vitamin D; Amaryl
Possible Mirapex side effects in female
Reported by a consumer/non-health professional from United States on 2011-11-09
Patient: female, weighing 69.0 kg (151.8 pounds)
Reactions: Nausea, Diarrhoea, Incorrect Dose Administered, Headache, Somnolence, Influenza Like Illness
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Gilenya
Dosage: 0.5 mg, qd
Administration route: Oral
Indication: Relapsing-Remitting Multiple Sclerosis
Start date: 2011-09-01
Mirapex
Dosage: 0.25 at 4pm and 0.5 at 8pm
Administration route: Oral
Gilenya
Dosage: 0.5 mg, qod
Administration route: Oral
End date: 2011-10-01
Other drugs received by patient: Aspirin; Janumet; Vitamin D; Zestril; Amaryl; Zocor; Fenofibrate; Hygroton
Possible Mirapex side effects in 38 year old male
Reported by a consumer/non-health professional from United States on 2011-11-08
Patient: 38 year old male, weighing 83.9 kg (184.6 pounds)
Reactions: Economic Problem, Gambling
Drug(s) suspected as cause:
Mirapex
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