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Rotigotine Side Effects

Common Rotigotine Side Effects

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

Fall (20)
Tremor (9)
Hyperhidrosis (8)
Dyskinesia (8)
Haematoma (7)
Death (7)
Acute Myocardial Infarction (5)
Accident (5)
Abnormal Behaviour (5)
Blood Pressure Increased (5)
Blood Urea Increased (5)
Balance Disorder (5)
Anaemia (5)
Nausea (5)
Femoral Neck Fracture (5)
Confusional State (5)
Femur Fracture (5)
Pyelonephritis (5)
Sudden Death (5)
Chest Pain (5)

➢ 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.

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.

Rotigotine Side Effects Reported to FDA

The following Rotigotine 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.


The appearance of Rotigotine 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.
Gingivitis Ulcerative, Glossitis, Mass
on Jan 30, 2014 Female from DE , 55 years of age, was diagnosed with and was treated with Rotigotine. Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: gingivitis ulcerative, glossitis, mass. Rotigotine dosage: Dose: 8 Mg/24 Hours.
Associated medications used:
  • Stalevo (100-75-75)
  • Ramipril
  • Bisoprolol
  • Clarium
Patient was hospitalized.

Urticaria
Patient was taking Rotigotine. Patient felt the following Rotigotine side effects: urticaria on Jan 22, 2014 from SG Additional patient health information: Female , 72 years of age, was diagnosed with and. Rotigotine dosage: N/A.
Multiple prescriptions taken:
  • Madopar
  • Selegiline


Extrapyramidal Disorder
Adverse event was reported on Dec 09, 2013 by a Male taking Rotigotine (Dosage: Dose: 8) . Location: GB , 75 years of age, After Rotigotine was administered, patient encountered several Rotigotine side effects: extrapyramidal disorder.
Multiple concurrent drugs taken:
  • Selegiline (Dose: 10)
  • Sinemet Plus (Dose: 600)


Pulmonary Thrombosis, Application Site Rash, Pyrexia, Urinary Tract Infection
on Nov 18, 2013 Female from CO , 78 years of age, was diagnosed with and was treated with Rotigotine. Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: pulmonary thrombosis, application site rash, pyrexia, urinary tract infection. Rotigotine dosage: Daily Dose : 4 Mg.
Associated medications used:
  • Ertapenim (1 Mg / 24 Hour)
  • Acetaminophen (500 Mg)
  • Metrotexate
  • Omeprazole
  • Acidofolico



Confusional State, Hallucination, Microangiopathy
on Nov 01, 2013 Male from GB , 64 years of age, was diagnosed with and was treated with Rotigotine. Patient felt the following Rotigotine side effects: confusional state, hallucination, microangiopathy. Rotigotine dosage: N/A. Patient was hospitalized.

Myocardial Bridging, Gastric Polyps, Large Intestine Polyp
Patient was taking Rotigotine. After Rotigotine was administered, patient encountered several Rotigotine side effects: myocardial bridging, gastric polyps, large intestine polyp on Nov 15, 2013 from CN Additional patient health information: Female , 55 years of age, weighting 141.1 lb, was diagnosed with and. Rotigotine dosage: N/A. Patient was hospitalized.

Hypersensitivity, Myalgia, Application Site Pruritus
Adverse event was reported on Sep 17, 2013 by a Female taking Rotigotine (Dosage: 10 Mg, 6 Mg + 2x2 Mg Patch = 10mg/day Transdermal?) was diagnosed with and. Location: US , 57 years of age, Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: hypersensitivity, myalgia, application site pruritus.
Associated medications used:
  • Carbidopa/levodopa
Patient was hospitalized.

Dyskinesia, Skin Irritation, Cyanosis, Chromaturia
on Sep 17, 2013 Male from US , 81 years of age, weighting 196.0 lb, was diagnosed with and was treated with Rotigotine. Patient felt the following Rotigotine side effects: dyskinesia, skin irritation, cyanosis, chromaturia. Rotigotine dosage: N/A. Patient was hospitalized.

Blood Pressure Increased
on Sep 17, 2013 Patient from US , 79 years of age, was diagnosed with and was treated with Rotigotine. After Rotigotine was administered, patient encountered several Rotigotine side effects: blood pressure increased. Rotigotine dosage: N/A.

Hallucination, Lethargy, Rash Macular
Patient was taking Rotigotine. Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: hallucination, lethargy, rash macular on Mar 18, 2013 from US Additional patient health information: Female , 21 years of age, weighting 110.2 lb, was diagnosed with and. Rotigotine dosage: 8 Mg, Half Patch Daily.
Associated medications used:
  • Baclofen
  • Sinemet
  • Amantadine
Patient was hospitalized.

Nightmare, Narcolepsy
Adverse event was reported on Mar 18, 2013 by a Male taking Rotigotine (Dosage: N/A) was diagnosed with and. Location: US , weighting 179.9 lb, Patient felt the following Rotigotine side effects: nightmare, narcolepsy.

Renal Failure, Dehydration, Nausea, Vomiting
on Jun 07, 2013 Female from US , 80 years of age, was diagnosed with and was treated with Rotigotine. After Rotigotine was administered, patient encountered several Rotigotine side effects: renal failure, dehydration, nausea, vomiting. Rotigotine dosage: N/A. Patient was hospitalized.

Application Site Reaction, Tremor, Nausea, Anxiety, Gait Disturbance
on Jun 07, 2013 Female from US , weighting 83.11 lb, was diagnosed with and was treated with Rotigotine. Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: application site reaction, tremor, nausea, anxiety, gait disturbance. Rotigotine dosage: (1 Mg Qd, Transdermal).
Associated medications used:
  • Sinemet
Patient was hospitalized.

Somnolence, Dizziness, Balance Disorder
Patient was taking Rotigotine. Patient felt the following Rotigotine side effects: somnolence, dizziness, balance disorder on Sep 12, 2013 from CO Additional patient health information: Female , 81 years of age, was diagnosed with and. Rotigotine dosage: Dose: 2mg/24 Hours.
Multiple prescriptions taken:
  • Amantadina (Dose: 100 Mg/24 Hours)
  • Akineton
  • Enalapril (Dose: 24mg/24 Hours)
Patient was hospitalized.

Pneumonia
Adverse event was reported on Sep 12, 2013 by a Female taking Rotigotine (Dosage: Dose: 4mg/24 Hours) was diagnosed with and. Location: CO , 82 years of age, After Rotigotine was administered, patient encountered several Rotigotine side effects: pneumonia.
Multiple concurrent drugs taken:
  • Levodopa (Dose: 1/2 Tablet Each 6 Hours)
  • Mirapex
Patient was hospitalized.

Multi-organ Failure
on Sep 11, 2013 Male from CO , 73 years of age, was diagnosed with and was treated with Rotigotine. Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: multi-organ failure. Rotigotine dosage: Daily Dose: 4 Mg /24 Hours.

Chest Pain, Anxiety, Dyspnoea
on Dec 03, 2013 Female from US , 73 years of age, weighting 448.0 lb, was diagnosed with and was treated with Rotigotine. Patient felt the following Rotigotine side effects: chest pain, anxiety, dyspnoea. Rotigotine dosage: N/A. Patient was hospitalized.

Colonic Pseudo-obstruction, Constipation, Abdominal Distension
Patient was taking Rotigotine. After Rotigotine was administered, patient encountered several Rotigotine side effects: colonic pseudo-obstruction, constipation, abdominal distension on Aug 22, 2013 from GB Additional patient health information: Male , 74 years of age, weighting 178.6 lb, was diagnosed with and. Rotigotine dosage: Dose : 6 Mg.
Multiple concurrent drugs taken:
  • Rasagiline (Dose: 1 Mg)
Patient was hospitalized.

Femoral Neck Fracture, Hypophagia, Dyskinesia, Fall
Adverse event was reported on Aug 16, 2013 by a Female taking Rotigotine (Dosage: N/A) was diagnosed with and. Location: NZ , 79 years of age, Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: femoral neck fracture, hypophagia, dyskinesia, fall.
Associated medications used:
  • Sinemet (Strength: 150+37 1/2)
  • Sinemet (25mg+100mg, One And A Half, 1 Month)
  • Entacapone (1 Month)
  • Paracetamol (1 Month)
  • Domperidone (1 Month)
  • Laxsol (2 Tablets, 1 Month)
  • Aspirin (Dispersible, 150 Mg In The Morning, 1 Month)
  • Diltiazem Ir (1 Month)
Patient was hospitalized and became disabled.

Femoral Neck Fracture, Fall, Agitation
on Jun 24, 2013 Female from GB , 76 years of age, was diagnosed with and was treated with Rotigotine. Patient felt the following Rotigotine side effects: femoral neck fracture, fall, agitation. Rotigotine dosage: N/A.
Multiple prescriptions taken:
  • Stalevo (100/25/200 X 5)
  • Furosemide
  • Sinemet Cr (25/100 X 1)
  • Rasagiline (Dose : 1 Mg)
  • Metformin
  • Ramipril
  • Atorvastatin
  • Co-codamol (As Required)


Pancytopenia
on May 29, 2013 Male from JP , 82 years of age, was diagnosed with and was treated with Rotigotine. After Rotigotine was administered, patient encountered several Rotigotine side effects: pancytopenia. Rotigotine dosage: N/A.

Maculopathy, Angiosclerosis, Optic Neuropathy
Patient was taking Rotigotine. Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: maculopathy, angiosclerosis, optic neuropathy on Oct 23, 2013 from IT Additional patient health information: Female , 66 years of age, weighting 194.0 lb, was diagnosed with and. Rotigotine dosage: N/A.

Acute Myocardial Infarction
Adverse event was reported on Jun 11, 2013 by a Male taking Rotigotine (Dosage: 4 Mg/24 Hours) was diagnosed with and. Location: CO , 85 years of age, Patient felt the following Rotigotine side effects: acute myocardial infarction.
Multiple prescriptions taken:
  • Aspirin
  • Losartan
  • Esomeprazole
  • Ipratropium Bromide (2 Puff Tid)
  • Acetaminophen
  • Entacapone/levedope/carbidope (200 Mg + 100 Mg + 25 Mg Every 6 Hours)
  • Trazodone


Craniocerebral Injury
on May 22, 2013 Male from CH , weighting 145.5 lb, was diagnosed with and was treated with Rotigotine. After Rotigotine was administered, patient encountered several Rotigotine side effects: craniocerebral injury. Rotigotine dosage: In Morning.
Multiple concurrent drugs taken:
  • Atacand
  • Marcoumar
  • Stalevo
Patient was hospitalized.

Restless Legs Syndrome
on Dec 17, 2012 Female from US , 69 years of age, was diagnosed with and was treated with Rotigotine. Directly after, patient experienced the unwanted or unexpected Rotigotine side effects: restless legs syndrome. Rotigotine dosage: N/A.

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PillPack: Pharmacy Simplified

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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


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  • 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.

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    Safety Alerts, Active Ingredients, Usage Information

    More About Rotigotine

    Side Effects reported to FDA: 169

    Rotigotine safety alerts: 2008

    Reported deaths: 19

    Reported hospitalizations: 71

    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 Parkinson‚??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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