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Rotigotine Side Effects

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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.

Rotigotine Side Effects Reported to FDA



Rotigotine Side Effect Report#9855255
Gingivitis Ulcerative, Glossitis, Mass
This is a report of a 55-year-old female patient (weight: NA) from DE, suffering from the following health symptoms/conditions: parkinson^s disease, who was treated with Rotigotine (dosage: Dose: 8 Mg/24 Hours, start time: 2008), combined with:
  • Stalevo (100-75-75)
  • Ramipril
  • Bisoprolol
  • Clarium
and developed a serious reaction and side effect(s): Gingivitis Ulcerative, Glossitis, Mass after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rotigotine treatment in female patients, resulting in Gingivitis Ulcerative side effect. The patient was hospitalized.
Rotigotine Side Effect Report#9834590
Urticaria
This report suggests a potential Rotigotine Urticaria side effect(s) that can have serious consequences. A 72-year-old female patient (weight: NA) from SG was diagnosed with the following symptoms/conditions: parkinson^s disease and used Rotigotine (dosage: NA) starting NS. After starting Rotigotine the patient began experiencing various side effects, including: UrticariaAdditional drugs used concurrently:
  • Madopar
  • Selegiline
Although Rotigotine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Urticaria, may still occur.
Rotigotine Side Effect Report#9741097
Extrapyramidal Disorder
This Extrapyramidal Disorder problem was reported by a physician from GB. A 75-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Rotigotine (dosage: Dose: 8). The following drugs were being taken at the same time:
  • Selegiline (Dose: 10)
  • Sinemet Plus (Dose: 600)
When using Rotigotine, the patient experienced the following unwanted symptoms/side effects: Extrapyramidal DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Extrapyramidal Disorder, may become evident only after a product is in use by the general population.
Rotigotine Side Effect Report#9693112
Pulmonary Thrombosis, Application Site Rash, Pyrexia, Urinary Tract Infection
This Pulmonary Thrombosis side effect was reported by a health professional from CO. A 78-year-old female patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease.The patient was prescribed Rotigotine (drug dosage: Daily Dose : 4 Mg), which was initiated on
May 28, 2012. Concurrently used drugs:
  • Ertapenim (1 Mg / 24 Hour)
  • Acetaminophen (500 Mg)
  • Metrotexate
  • Omeprazole
  • Acidofolico
.After starting to take Rotigotine the consumer reported adverse symptoms, such as: Pulmonary Thrombosis, Application Site Rash, Pyrexia, Urinary Tract InfectionThese side effects may potentially be related to Rotigotine.
Rotigotine Side Effect Report#9620086
Confusional State, Hallucination, Microangiopathy
This is a report of a 64-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: parkinson^s disease, who was treated with Rotigotine (dosage: NA, start time: 200606), combined with: NA. and developed a serious reaction and side effect(s): Confusional State, Hallucination, Microangiopathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rotigotine treatment in male patients, resulting in Confusional State side effect. The patient was hospitalized.
Rotigotine Side Effect Report#9587356
Myocardial Bridging, Gastric Polyps, Large Intestine Polyp
This report suggests a potential Rotigotine Myocardial Bridging side effect(s) that can have serious consequences. A 55-year-old female patient (weight: NA) from CN was diagnosed with the following symptoms/conditions: parkinson^s disease and used Rotigotine (dosage: NA) starting
Apr 08, 2013. After starting Rotigotine the patient began experiencing various side effects, including: Myocardial Bridging, Gastric Polyps, Large Intestine PolypAdditional drugs used concurrently: NA.The patient was hospitalized. Although Rotigotine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Myocardial Bridging, may still occur.
Rotigotine Side Effect Report#9555241
Hypersensitivity, Myalgia, Application Site Pruritus
This Hypersensitivity problem was reported by a consumer or non-health professional from US. A 57-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: parkinson^s disease. On NS this consumer started treatment with Rotigotine (dosage: 10 Mg, 6 Mg + 2x2 Mg Patch = 10mg/day Transdermal?). The following drugs were being taken at the same time:
  • Carbidopa/levodopa
When using Rotigotine, the patient experienced the following unwanted symptoms/side effects: Hypersensitivity, Myalgia, Application Site PruritusThe 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 Hypersensitivity, may become evident only after a product is in use by the general population.
Rotigotine Side Effect Report#9555238
Dyskinesia, Skin Irritation, Cyanosis, Chromaturia
This Dyskinesia side effect was reported by a physician from US. A 81-year-old male patient (weight:NA) experienced the following symptoms/conditions: restless legs syndrome,parkinson^s disease.The patient was prescribed Rotigotine (drug dosage: NA), which was initiated on 2013. Concurrently used drugs: NA..After starting to take Rotigotine the consumer reported adverse symptoms, such as: Dyskinesia, Skin Irritation, Cyanosis, ChromaturiaThese side effects may potentially be related to Rotigotine. The patient was hospitalized.
Rotigotine Side Effect Report#9555225
Blood Pressure Increased
This is a report of a 79-year-old patient (weight: NA) from US, suffering from the following health symptoms/conditions: parkinson^s disease, who was treated with Rotigotine (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Blood Pressure Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rotigotine treatment in patients, resulting in Blood Pressure Increased side effect.
Rotigotine Side Effect Report#9552725
Hallucination, Lethargy, Rash Macular
This report suggests a potential Rotigotine Hallucination side effect(s) that can have serious consequences. A 21-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hereditary spastic paraplegia and used Rotigotine (dosage: 8 Mg, Half Patch Daily) starting NS. After starting Rotigotine the patient began experiencing various side effects, including: Hallucination, Lethargy, Rash MacularAdditional drugs used concurrently:
  • Baclofen
  • Sinemet
  • Amantadine
The patient was hospitalized. Although Rotigotine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hallucination, may still occur.
Rotigotine Side Effect Report#9552696
Nightmare, Narcolepsy
This Nightmare problem was reported by a physician from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: parkinson^s disease. On 2013 this consumer started treatment with Rotigotine (dosage: NA). The following drugs were being taken at the same time: NA. When using Rotigotine, the patient experienced the following unwanted symptoms/side effects: Nightmare, NarcolepsyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nightmare, may become evident only after a product is in use by the general population.
Rotigotine Side Effect Report#9548772
Renal Failure, Dehydration, Nausea, Vomiting
This Renal Failure side effect was reported by a health professional from US. A 80-year-old female patient (weight:NA) experienced the following symptoms/conditions: restless legs syndrome.The patient was prescribed Rotigotine (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Rotigotine the consumer reported adverse symptoms, such as: Renal Failure, Dehydration, Nausea, VomitingThese side effects may potentially be related to Rotigotine. The patient was hospitalized.
Rotigotine Side Effect Report#9548768
Application Site Reaction, Tremor, Nausea, Anxiety, Gait Disturbance
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: parkinson^s disease, who was treated with Rotigotine (dosage: (1 Mg Qd, Transdermal), start time:
Mar 21, 2013), combined with:
  • Sinemet
and developed a serious reaction and side effect(s): Application Site Reaction, Tremor, Nausea, Anxiety, Gait Disturbance after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rotigotine treatment in female patients, resulting in Application Site Reaction side effect. The patient was hospitalized.
Rotigotine Side Effect Report#9519278
Somnolence, Dizziness, Balance Disorder
This report suggests a potential Rotigotine Somnolence side effect(s) that can have serious consequences. A 81-year-old female patient (weight: NA) from CO was diagnosed with the following symptoms/conditions: parkinson^s disease and used Rotigotine (dosage: Dose: 2mg/24 Hours) starting
Apr 19, 2013. After starting Rotigotine the patient began experiencing various side effects, including: Somnolence, Dizziness, Balance DisorderAdditional drugs used concurrently:
  • Amantadina (Dose: 100 Mg/24 Hours)
  • Akineton
  • Enalapril (Dose: 24mg/24 Hours)
The patient was hospitalized. Although Rotigotine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Somnolence, may still occur.
Rotigotine Side Effect Report#9519268
Pneumonia
This Pneumonia problem was reported by a health professional from CO. A 82-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: parkinson^s disease. On
Apr 16, 2013 this consumer started treatment with Rotigotine (dosage: Dose: 4mg/24 Hours). The following drugs were being taken at the same time:
  • Levodopa (Dose: 1/2 Tablet Each 6 Hours)
  • Mirapex
When using Rotigotine, the patient experienced the following unwanted symptoms/side effects: PneumoniaThe 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 Pneumonia, may become evident only after a product is in use by the general population.
Rotigotine Side Effect Report#9515329
Multi-organ Failure
This Multi-organ Failure side effect was reported by a health professional from CO. A 73-year-old male patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease.The patient was prescribed Rotigotine (drug dosage: Daily Dose: 4 Mg /24 Hours), which was initiated on
Oct 10, 2012. Concurrently used drugs: NA..After starting to take Rotigotine the consumer reported adverse symptoms, such as: Multi-organ FailureThese side effects may potentially be related to Rotigotine.
Rotigotine Side Effect Report#9513135
Chest Pain, Anxiety, Dyspnoea
This is a report of a 73-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: restless legs syndrome,renal failure chronic,hyperuricaemia,gastrooesophageal reflux disease,hypertension, who was treated with Rotigotine (dosage: NA, start time:
Mar 25, 2013), combined with: NA. and developed a serious reaction and side effect(s): Chest Pain, Anxiety, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rotigotine treatment in female patients, resulting in Chest Pain side effect. The patient was hospitalized.
Rotigotine Side Effect Report#9471306
Colonic Pseudo-obstruction, Constipation, Abdominal Distension
This report suggests a potential Rotigotine Colonic Pseudo-obstruction side effect(s) that can have serious consequences. A 74-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: parkinson^s disease and used Rotigotine (dosage: Dose : 6 Mg) starting
Jan 01, 2011. After starting Rotigotine the patient began experiencing various side effects, including: Colonic Pseudo-obstruction, Constipation, Abdominal DistensionAdditional drugs used concurrently:
  • Rasagiline (Dose: 1 Mg)
The patient was hospitalized. Although Rotigotine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Colonic Pseudo-obstruction, may still occur.
Rotigotine Side Effect Report#9461990
Femoral Neck Fracture, Hypophagia, Dyskinesia, Fall
This Femoral Neck Fracture problem was reported by a physician from NZ. A 79-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: parkinson^s disease. On
Jul 12, 2013 this consumer started treatment with Rotigotine (dosage: NA). The following drugs were being taken at the same time:
  • 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)
When using Rotigotine, the patient experienced the following unwanted symptoms/side effects: Femoral Neck Fracture, Hypophagia, Dyskinesia, FallThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Femoral Neck Fracture, may become evident only after a product is in use by the general population.
Rotigotine Side Effect Report#9363692
Femoral Neck Fracture, Fall, Agitation
This Femoral Neck Fracture side effect was reported by a health professional from GB. A 76-year-old female patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease.The patient was prescribed Rotigotine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Stalevo (100/25/200 X 5)
  • Furosemide
  • Sinemet Cr (25/100 X 1)
  • Rasagiline (Dose : 1 Mg)
  • Metformin
  • Ramipril
  • Atorvastatin
  • Co-codamol (As Required)
.After starting to take Rotigotine the consumer reported adverse symptoms, such as: Femoral Neck Fracture, Fall, AgitationThese side effects may potentially be related to Rotigotine.
Rotigotine Side Effect Report#9310637
Pancytopenia
This is a report of a 82-year-old male patient (weight: NA) from JP, suffering from the following health symptoms/conditions: parkinson^s disease, who was treated with Rotigotine (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Pancytopenia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rotigotine treatment in male patients, resulting in Pancytopenia side effect.
Rotigotine Side Effect Report#9306413
Maculopathy, Angiosclerosis, Optic Neuropathy
This report suggests a potential Rotigotine Maculopathy side effect(s) that can have serious consequences. A 66-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: parkinson^s disease and used Rotigotine (dosage: NA) starting 2002. After starting Rotigotine the patient began experiencing various side effects, including: Maculopathy, Angiosclerosis, Optic NeuropathyAdditional drugs used concurrently: NA. Although Rotigotine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Maculopathy, may still occur.
Rotigotine Side Effect Report#9305312
Acute Myocardial Infarction
This Acute Myocardial Infarction problem was reported by a health professional from CO. A 85-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: parkinson^s disease. On
Jan 28, 2013 this consumer started treatment with Rotigotine (dosage: 4 Mg/24 Hours). The following drugs were being taken at the same time:
  • Aspirin
  • Losartan
  • Esomeprazole
  • Ipratropium Bromide (2 Puff Tid)
  • Acetaminophen
  • Entacapone/levedope/carbidope (200 Mg + 100 Mg + 25 Mg Every 6 Hours)
  • Trazodone
When using Rotigotine, the patient experienced the following unwanted symptoms/side effects: Acute Myocardial InfarctionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Acute Myocardial Infarction, may become evident only after a product is in use by the general population.
Rotigotine Side Effect Report#9304069
Craniocerebral Injury
This Craniocerebral Injury side effect was reported by a physician from CH. A male patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease,hypertension.The patient was prescribed Rotigotine (drug dosage: In Morning), which was initiated on
Aug 20, 2012. Concurrently used drugs:
  • Atacand
  • Marcoumar
  • Stalevo
.After starting to take Rotigotine the consumer reported adverse symptoms, such as: Craniocerebral InjuryThese side effects may potentially be related to Rotigotine. The patient was hospitalized.
Rotigotine Side Effect Report#9293866
Restless Legs Syndrome
This is a report of a 69-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: restless legs syndrome, who was treated with Rotigotine (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Restless Legs Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Rotigotine treatment in female patients, resulting in Restless Legs Syndrome side effect.


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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.


What are common Rotigotine Side Effects for Women?

Women Side EffectsReports
Fall 12
Dyskinesia 5
Haematoma 5
Pyelonephritis 5
Balance Disorder 4
Death 4
Facial Bones Fracture 4
Nausea 4
Blood Urea Increased 3
Chest Pain 3

What are common Rotigotine Side Effects for Men?

Men Side EffectsReports
Fall 8
Hyperhidrosis 8
Tremor 7
Abnormal Behaviour 4
Cardiac Murmur 4
Confusional State 4
Dysarthria 4
Femur Fracture 4
Insomnia 4
Pain In Extremity 4

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.

    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.

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    Rotigotine 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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