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Rotigotine Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 125 

Pyelonephritis (7096135-8)
on Oct 20, 2010 Female from ROMANIA , weighting 141.1 lb, was diagnosed with
  • parkinson's disease
and was treated with Rotigotine (rotigotine). Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: pyelonephritis. Rotigotine (rotigotine) dosage: (4 Mg Qd Transdermal).
Associated medications used:
  • Romparkin (romparkin) (not Specified) ((2 Mg Tid))
  • Viregyt-k (viregyt) ((100 Mg Bid))
  • Requip ((1 G Tid))
  • Piracetam
  • Stugeron
  • Stilnox /00914901/
Patient was hospitalized.

Chest Pain, Dehydration, Electrocardiogram Repolarisation Abnormality, Groin Pain, Hyponatraemia, Left Ventricular Hypertrophy, Normochromic Normocytic Anaemia, Renal Failure Acute, Thrombocytopenia (7092118-2)
Patient was taking Rotigotine. Patient felt the following Rotigotine side effects: chest pain, dehydration, electrocardiogram repolarisation abnormality, groin pain, hyponatraemia, left ventricular hypertrophy, normochromic normocytic anaemia, renal failure acute, thrombocytopenia on Oct 18, 2010 from UNITED STATES Additional patient health information: Female , weighting 224.0 lb, was diagnosed with
  • parkinson's disease
and. Rotigotine dosage: (6 Mg Qd), (6 Mg Qd). Patient was hospitalized.

Angina Unstable, Blood Creatinine Increased, Blood Urea Increased (7088375-9)
Adverse event was reported on Oct 18, 2010 by a Female taking Rotigotine (Dosage: (6 Mg Qd)) was diagnosed with
  • parkinson's disease
and. Location: UNITED STATES , 67 years of age, After Rotigotine was administered, patient encountered several Rotigotine side effects: angina unstable, blood creatinine increased, blood urea increased. Patient was hospitalized.

Pyelonephritis (7082662-6)
on Oct 14, 2010 Female from ROMANIA , weighting 141.1 lb, was diagnosed with
  • parkinson's disease
and was treated with Rotigotine (rotigotine). Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: pyelonephritis. Rotigotine (rotigotine) dosage: (4 Mg Qd Transdermal).
Associated medications used:
  • Romprkin (romparkin) (not Speciifed) ((2 Mg Tid))
  • Viregyt-k (viregyt) ((100 Mg Bid))
  • Requip ((1 G Tid))
  • Piracetam
  • Stugeron
  • Stilnox /00914901/
Patient was hospitalized.


Pancytopenia (7081707-7)
on Oct 09, 2010 Male from GERMANY , weighting 211.6 lb, was diagnosed with
  • parkinson's disease
and was treated with Rotigotine (neupro). Patient felt the following Rotigotine side effects: pancytopenia. Rotigotine (neupro) dosage: See Image. Patient was hospitalized.

(7077722-X)
Patient was taking Rotigotine (rotigotine). on Oct 08, 2010 from ROMANIA Additional patient health information: Female , weighting 141.1 lb, was diagnosed with
  • parkinson's disease
and. Rotigotine (rotigotine) dosage: (4 Mg Qd Transdermal).
Multiple concurrent drugs taken:
  • Romparkin
  • Viregyt-k
  • Piracetam
  • Stugeron
  • Stilnox /00914901/


Amnesia, Face Injury, Facial Bones Fracture, Fall, Loss Of Consciousness (7051829-5)
Adverse event was reported on Oct 01, 2010 by a Female taking Rotigotine (Dosage: (4 Mg Qd Topical)) was diagnosed with
  • parkinson's disease
and. Location: UNITED STATES , weighting 170.0 lb, Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: amnesia, face injury, facial bones fracture, fall, loss of consciousness.
Associated medications used:
  • Hydrocodone
  • Protonix
  • Allegra /0134201/
  • Vesicare
  • Ativan
  • Metformin
  • Glipizide
  • Sudafed /00070002/
Patient was hospitalized.

(7048922-X)
on Sep 14, 2010 Male from GERMANY , 61 years of age, was diagnosed with
  • restless legs syndrome
and was treated with Rotigotine (rotigotine). . Rotigotine (rotigotine) dosage: Transdermal Patch.

Myocardial Infarction (7047233-6)
on Sep 28, 2010 Male from GERMANY , 61 years of age, weighting 216.1 lb, was diagnosed with
  • restless legs syndrome
and was treated with Rotigotine (rotigotine). After Rotigotine was administered, patient encountered several Rotigotine side effects: myocardial infarction. Rotigotine (rotigotine) dosage: Transdermal Patch Transdermal.
Multiple concurrent drugs taken:
  • Amlodipin /00972401/ (amlodipine)
  • Nebivolol Hcl
  • Godamed /00002701/ (acetylsalicylic Acid)
  • Sertralin /01011401/ (sertraline)


Back Pain, Bedridden, Compression Fracture, Fall, Thoracic Vertebral Fracture (7032398-2)
Patient was taking Rotigotine. Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: back pain, bedridden, compression fracture, fall, thoracic vertebral fracture on Sep 22, 2010 from UNITED STATES Additional patient health information: Female , weighting 129.0 lb, was diagnosed with
  • restless legs syndrome
and. Rotigotine dosage: (4 Mg 1x/24 Hours Transdermal).
Associated medications used:
  • Docusate
  • Sinemet
  • Tylenol (caplet)
  • Prednisone
  • Oxycodone
  • Omeprazole
  • Atenolol
  • Hydralazine
Patient was hospitalized.

Acute Myocardial Infarction, Cardiac Arrest, Facial Bones Fracture, Fall, Haematoma (7032397-0)
Adverse event was reported on Sep 24, 2010 by a Female taking Rotigotine (Dosage: (4 Mg Qd Transdermal)) was diagnosed with
  • parkinson's disease
and. Location: UNITED STATES , weighting 170.0 lb, Patient felt the following Rotigotine side effects: acute myocardial infarction, cardiac arrest, facial bones fracture, fall, haematoma.
Multiple prescriptions taken:
  • Allegra
  • Protonix
  • Vesicare
  • Ativan
  • Metformin
  • Glipizide
  • Sudafed /00076302/
  • Coenzyme Q10 /00517201/


Amnesia, Blood Glucose Increased, Facial Bones Fracture, Fall, Loss Of Consciousness, Pain (7023470-1)
on Sep 15, 2010 Female from UNITED STATES , weighting 170.0 lb, was diagnosed with
  • parkinson's disease
and was treated with Rotigotine. After Rotigotine was administered, patient encountered several Rotigotine side effects: amnesia, blood glucose increased, facial bones fracture, fall, loss of consciousness, pain. Rotigotine dosage: 4 Mg Qd Topical.
Multiple concurrent drugs taken:
  • Hydrocodone
  • Protonix
  • Allegra
  • Vesicare
  • Ativan
  • Metformin Hcl
  • Glipizide
  • Sudafed 12 Hour
Patient was hospitalized.

Delusion, Depression, Incorrect Dose Administered, Jealous Delusion, Legal Problem, Motor Dysfunction, Sexual Dysfunction (7021662-9)
on Sep 15, 2010 Male from UNITED KINGDOM , 37 years of age, was treated with Rotigotine (rotigotine). Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: delusion, depression, incorrect dose administered, jealous delusion, legal problem, motor dysfunction, sexual dysfunction. Rotigotine (rotigotine) dosage: (4 Mg).
Associated medications used:
  • Levodopa (levodopa) ((300 Mg) ; (900 Mg))
  • Cabergoline ((2 Mg) ; (4 Mg) ; (self Medicated Twice The Dosage))
  • Benzatropine
  • Trihexyphenidyl Hcl


Acute Myocardial Infarction, Cardiac Arrest, Facial Bones Fracture, Fall, Haematoma, Musculoskeletal Stiffness, Refusal Of Treatment By Patient, Treatment Noncompliance (6995099-2)
Patient was taking Rotigotine. Patient felt the following Rotigotine side effects: acute myocardial infarction, cardiac arrest, facial bones fracture, fall, haematoma, musculoskeletal stiffness, refusal of treatment by patient, treatment noncompliance on Sep 07, 2010 from UNITED STATES Additional patient health information: Female , weighting 170.0 lb, was diagnosed with
  • parkinson's disease
and. Rotigotine dosage: (4 Mg Qd Transdermal).
Multiple prescriptions taken:
  • Allegra
  • Protonix
  • Visicare /01735901/
  • Ativan
  • Metformin
  • Glipizide
  • Sudafed /00076302/
  • Coenzyme Q10 /00517201/


Akinesia, Disturbance In Attention, Dysphagia, Pain, Pneumonia, Sleep Disorder (6987377-8)
Adverse event was reported on Sep 09, 2010 by a Male taking Rotigotine (rotigotine) Transdermal Patch, Transdermal Patch (Dosage: 1 Mg Qd, Evenings, 4 Mg) was diagnosed with
  • parkinson's disease
and. Location: GERMANY , 90 years of age, After Rotigotine was administered, patient encountered several Rotigotine side effects: akinesia, disturbance in attention, dysphagia, pain, pneumonia, sleep disorder.
Multiple concurrent drugs taken:
  • Amantadine Hcl
  • Multi-vitamins
  • Diovan
  • Clopidogrel
  • Madopar Lt


Abnormal Behaviour, Confusional State, Disease Progression, Hyperhidrosis, Oedema Peripheral, On And Off Phenomenon, Parkinson's Disease, Rhabdomyolysis (6981954-6)
on Aug 30, 2010 Male from GERMANY , 70 years of age, was diagnosed with
  • parkinson's disease
and was treated with Rotigotine (rotigotine). Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: abnormal behaviour, confusional state, disease progression, hyperhidrosis, oedema peripheral, on and off phenomenon, parkinson's disease, rhabdomyolysis. Rotigotine (rotigotine) dosage: 8 Mcg, Qd, (16 Mg Qd), (16 Mg, Qd).
Associated medications used:
  • Quetiapine (12.5 Mg, Daily,)
  • Hydrochlorothiazide
  • Rasagiline
  • Stalevo 100
  • Antihypertensives


Femur Fracture, Impulsive Behaviour, Road Traffic Accident, Wrist Fracture (6828619-9)
on Jun 22, 2010 Male from UNITED STATES , 54 years of age, was diagnosed with
  • parkinson's disease
and was treated with Rotigotine. Patient felt the following Rotigotine side effects: femur fracture, impulsive behaviour, road traffic accident, wrist fracture. Rotigotine dosage: (4 Mg For 4 Weeks Transdermal).

Diplopia, Dysarthria, Malaise, Nausea (6785101-5)
Patient was taking Rotigotine (rotigotine). After Rotigotine was administered, patient encountered several Rotigotine side effects: diplopia, dysarthria, malaise, nausea on Jun 08, 2010 from UNITED KINGDOM Additional patient health information: Male , 65 years of age, weighting 199.3 lb, was diagnosed with
  • parkinson's disease
  • depression
  • pain
  • sleep disorder
and. Rotigotine (rotigotine) dosage: (4 Mg Transdermal).
Multiple concurrent drugs taken:
  • Amitriptyline Hydrochloride ((25 Mg))
  • Amitriptyline Hydrochloride ((25 Mg))
  • Amitriptyline Hydrochloride ((25 Mg))
  • Atorvastatin Calcium
  • Buprenorphine (buprenorphine) ((25 Ug Q1h))
  • Lansoprazole ((increased Dose))
  • Selegiline Hcl ((0.05 Mg Oral))
  • Sinemet Cr ((1 Df 9x/day))


Abnormal Behaviour, Bronchopneumonia, Fall, Femur Fracture (6766519-3)
Adverse event was reported on May 27, 2010 by a Female taking Rotigotine (rotigotine) (Dosage: (transdermal) (6 Mg Transdermal)) . Location: UNITED KINGDOM , 66 years of age, Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: abnormal behaviour, bronchopneumonia, fall, femur fracture.

Abnormal Behaviour, Aggression, Application Site Rash, Dermatitis Contact, Dopamine Dysregulation Syndrome, Dyskinesia, Hypersexuality, Incorrect Dose Administered, Insomnia (6755294-4)
on May 20, 2010 Male from UNITED KINGDOM , 25 years of age, was treated with Rotigotine (rotigotine). Patient felt the following Rotigotine side effects: abnormal behaviour, aggression, application site rash, dermatitis contact, dopamine dysregulation syndrome, dyskinesia, hypersexuality, incorrect dose administered, insomnia. Rotigotine (rotigotine) dosage: (4 Mg Qd Transdermal).
Multiple prescriptions taken:
  • Fluoxetine Hcl
Patient was hospitalized and became disabled.

Anxiety, Chest Pain, Dyspnoea, Hyperhidrosis, Irritable Bowel Syndrome, Micturition Urgency, Muscle Spasms, Nocturia (6744215-6)
on May 12, 2010 Male from SWITZERLAND , 56 years of age, was treated with Rotigotine (rotigotine). After Rotigotine was administered, patient encountered several Rotigotine side effects: anxiety, chest pain, dyspnoea, hyperhidrosis, irritable bowel syndrome, micturition urgency, muscle spasms, nocturia. Rotigotine (rotigotine) dosage: (6 Mg Qd Transdermal).
Multiple concurrent drugs taken:
  • Carbidopa W/entacapone W/levodopa
Patient was hospitalized.

Perirectal Abscess (6742813-7)
Patient was taking Rotigotine. Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: perirectal abscess on May 11, 2010 from UNITED STATES Additional patient health information: Male , weighting 152.0 lb, was diagnosed with
  • parkinson's disease
and. Rotigotine dosage: (2 Mg Qd Transdermal).
Associated medications used:
  • Sinemet Cr
  • Sinemet
  • Aricept
  • Azilect
  • Zocor
  • Aspirin
  • Midodrine Hydrochloride
  • Requip
Patient was hospitalized.

Confusional State, Delirium, Psychotic Disorder (6732706-3)
Adverse event was reported on May 06, 2010 by a Female taking Rotigotine (rotigotine) (Dosage: (6 Mg Qd Transdermal)) was diagnosed with
  • parkinson's disease
and. Location: GERMANY , weighting 123.5 lb, Patient felt the following Rotigotine side effects: confusional state, delirium, psychotic disorder.
Multiple prescriptions taken:
  • Amantadin (amantadin) ((oral))
  • Lexotanil (lexotanil ) (not Specified) ((1.5 Mg Qd Oral))
Patient was hospitalized.

Cerebrovascular Accident (6731890-5)
on May 06, 2010 Female from UNITED STATES , weighting 119.0 lb, was diagnosed with
  • parkinson's disease
and was treated with Rotigotine. After Rotigotine was administered, patient encountered several Rotigotine side effects: cerebrovascular accident. Rotigotine dosage: 6 Mg Qd Transdermal.
Multiple concurrent drugs taken:
  • Sinemet
  • Comtan
  • Prilosec /00661201/
  • Amantadine Hcl
  • Didronel /00553202/
  • Detrol /01350201/
  • Paxil
  • Seroquel


Blood Glucose Increased, Bradycardia, Haematocrit Decreased, Haemoglobin Decreased, Myoglobin Blood Decreased, Syncope (6701564-5)
on Apr 13, 2010 Male from UNITED STATES , weighting 167.0 lb, was diagnosed with
  • parkinson's disease
and was treated with Rotigotine. Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: blood glucose increased, bradycardia, haematocrit decreased, haemoglobin decreased, myoglobin blood decreased, syncope. Rotigotine dosage: 6 Mg Qd Transdermal.
Associated medications used:
  • Accupril
Patient was hospitalized.

Showing 1-25 of 125 

Rotigotine Health Episodes

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Rotigotine Information

More About Rotigotine

Side Effects reported to FDA: 125. View Rotigotine Adverse Reports

Rotigotine safety alerts: 2008

Reported deaths: 9

Reported hospitalizations: 41

Neupro (rotigotine transdermal system)

Audience: Neurologists, other healthcare professionals, patients

[Posted 04/09/2008] Schwarz Pharma informed healthcare professionals and patients of the recall of Neupro, a transdermal delivery system worn on the skin and used to treat early stage Parkinsonā??s disease, at the end of April 2008, because of the formation of rotigotine crystals in the patches. When the drug crystallizes, less drug is available to be absorbed through the skin and the efficacy of the product may vary. Healthcare professionals should not initiate any new patients on Neupro and should begin to down-titrate all patients currently using the product per the guidelines in the product labeling. Patients should NOT abruptly discontinue therapy. Abrupt withdrawal of dopamine agonists has been associated with a syndrome resembling neuroleptic malignant syndrome or akinetic crises.

[April 8, 2008 - Drug Shortage Information - FDA]

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