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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
This is a report of a 55-year-old female patient (weight: NA) from DE, suffering from the following 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). The consumer presented with:
  • Gingivitis Ulcerative
  • Glossitis
  • Mass
which developed 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.

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. Soon after starting Rotigotine the patient began experiencing various side effects, including:
  • Urticaria
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.

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 commencing Rotigotine, the patient experienced the following unwanted symptoms/side effects:
  • Extrapyramidal Disorder
Although 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.

Pulmonary Thrombosis, Application Site Rash, Pyrexia, Urinary Tract Infection
This is a report of a 78-year-old female patient (weight: NA) from CO. The patient developed the following symptoms/conditions: parkinson^s disease and was treated with Rotigotine (dosage: Daily Dose : 4 Mg) starting May 28, 2012. Concurrently used drugs:
  • Ertapenim (1 Mg / 24 Hour)
  • Acetaminophen (500 Mg)
  • Metrotexate
  • Omeprazole
  • Acidofolico
Soon after that, the consumer experienced the following side effects:
  • Pulmonary Thrombosis
  • Application Site Rash
  • Pyrexia
  • Urinary Tract Infection
This opens a possibility that Rotigotine treatment could cause the above reactions, including pulmonary thrombosis, and some female subjects may be more susceptible.


Confusional State, Hallucination, Microangiopathy
A 64-year-old male patient (weight: NA) from GB with the following symptoms/conditions: parkinson^s disease started Rotigotine treatment (dosage: NA) on 200606. Soon after starting Rotigotine treatment, the subject experienced various side effects, including:
  • Confusional State
  • Hallucination
  • Microangiopathy
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some male patients could be more vulnerable to Rotigotine.

Myocardial Bridging, Gastric Polyps, Large Intestine Polyp
A 55-year-old female patient from CN (weight: NA) experienced symptoms, such as: parkinson^s disease and was treated with Rotigotine(dosage: NA). The treatment was initiated on Apr 08, 2013. After that a consumer reported the following side effect(s):
  • Myocardial Bridging
  • Gastric Polyps
  • Large Intestine Polyp
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Rotigotine efficacy: NA.The patient was hospitalized.

Hypersensitivity, Myalgia, Application Site Pruritus
In this report, Rotigotine was administered for the following condition: parkinson^s disease.A 57-year-old female consumer from US (weight: NA) started Rotigotine treatment (dosage: 10 Mg, 6 Mg + 2x2 Mg Patch = 10mg/day Transdermal?) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Hypersensitivity
  • Myalgia
  • Application Site Pruritus
A possible interaction with other drugs could have contributed to this reaction:
  • Carbidopa/levodopa
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Rotigotine treatment could be related to the listed above side effect(s).

Dyskinesia, Skin Irritation, Cyanosis, Chromaturia
This is a report of the following Rotigotine side effect(s):
  • Dyskinesia
  • Skin Irritation
  • Cyanosis
  • Chromaturia
A 81-year-old male patient from US (weight: NA) presented with the following condition: restless legs syndrome,parkinson^s disease and received a treatment with Rotigotine (dosage: NA) starting: 2013.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Rotigotine treatment could be associated with the listed above side effect(s).

Blood Pressure Increased
This Rotigotine report was submitted by a 79-year-old consumer from US (weight: NA). The patient was diagnosed with: parkinson^s disease and Rotigotine was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Blood Pressure Increased
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Rotigotine treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Hallucination, Lethargy, Rash Macular
This is a report of a possible correlation between Rotigotine use and the following symptoms/side effect(s):
  • Hallucination
  • Lethargy
  • Rash Macular
which could contribute to an assessment of Rotigotine risk profile.A 21-year-old female consumer from US (weight: NA) was suffering from hereditary spastic paraplegia and was treated with Rotigotine (dosage: 8 Mg, Half Patch Daily) starting NS.Other concurrent medications:
  • Baclofen
  • Sinemet
  • Amantadine
The patient was hospitalized.

Nightmare, Narcolepsy
A male patient from US (weight: NA) presented with the following symptoms: parkinson^s disease and after a treatment with Rotigotine (dosage: NA) experienced the following side effect(s):
  • Nightmare
  • Narcolepsy
The treatment was started on 2013. Rotigotine was used in combination with the following drugs: NA.This report could alert potential Rotigotine consumers.

Renal Failure, Dehydration, Nausea, Vomiting
In this report, a 80-year-old female patient from US (weight: NA) was affected by a possible Rotigotine side effect.The patient was diagnosed with restless legs syndrome. After a treatment with Rotigotine (dosage: NA, start date: NS), the patient experienced the following side effect(s):
  • Renal Failure
  • Dehydration
  • Nausea
  • Vomiting
The following simultaneously used drugs could have led to this reaction: NA.The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Rotigotine treatment.

Application Site Reaction, Tremor, Nausea, Anxiety, Gait Disturbance
This is a report of a female patient from US (weight: NA), who used Rotigotine (dosage: (1 Mg Qd, Transdermal)) for a treatment of parkinson^s disease. After starting a treatment on Mar 21, 2013, the patient experienced the following side effect(s):
  • Application Site Reaction
  • Tremor
  • Nausea
  • Anxiety
  • Gait Disturbance
The following drugs could possibly have interacted with the Rotigotine treatment
  • Sinemet
The patient was hospitalized.Taken together, these observations suggest that a Rotigotine treatment could be related to side effect(s), such as Application Site Reaction, Tremor, Nausea, Anxiety, Gait Disturbance.

Somnolence, Dizziness, Balance Disorder
This somnolence side effect was reported by a health professional from CO. A 81-year-old female patient (weight:NA) experienced the following symptoms/conditions: parkinson^s disease. The patient was prescribed Rotigotine (dosage: Dose: 2mg/24 Hours), which was started on Apr 19, 2013. Concurrently used drugs:
  • Amantadina (Dose: 100 Mg/24 Hours)
  • Akineton
  • Enalapril (Dose: 24mg/24 Hours)
When starting to take Rotigotine the consumer reported the following symptoms:
  • Somnolence
  • Dizziness
  • Balance Disorder
The patient was hospitalized. These side effects may potentially be related to Rotigotine.

Pneumonia
This is a Rotigotine side effect report of a 82-year-old female patient (weight:NA) from CO, suffering from the following symptoms/conditions: parkinson^s disease, who was treated with Rotigotine (dosage:Dose: 4mg/24 Hours, start time: Apr 16, 2013), combined with:
  • Levodopa (Dose: 1/2 Tablet Each 6 Hours)
  • Mirapex
, and developed a serious reaction and a pneumonia side effect. The patient presented with:
  • Pneumonia
which developed after the beginning of treatment. The patient was hospitalized. This side effect report can indicate a possible existence of increased vulnerability to Rotigotine treatment in female patients suffering from parkinson^s disease, resulting in pneumonia.

Multi-organ Failure
This report suggests a potential Rotigotine multi-organ failure side effect(s) that can have serious consequences. A 73-year-old male patient from CO (weight:NA) was diagnosed with the following health condition(s): parkinson^s disease and used Rotigotine (dosage: Daily Dose: 4 Mg /24 Hours) starting Oct 10, 2012. Soon after starting Rotigotine the patient began experiencing various side effects, including:
  • Multi-organ Failure
Drugs used concurrently:NA. Although Rotigotine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as multi-organ failure, may still occur.

Chest Pain, Anxiety, Dyspnoea
This chest pain problem was reported by a physician from US. A 73-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): restless legs syndrome,renal failure chronic,hyperuricaemia,gastrooesophageal reflux disease,hypertension.On Mar 25, 2013 a consumer started treatment with Rotigotine (dosage: NA). The following drugs/medications were being taken at the same time: NA. When commencing Rotigotine, the patient experienced the following unwanted symptoms /side effects:
  • Chest Pain
  • Anxiety
  • Dyspnoea
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as chest pain, may become evident only after a product is in use by the general population.

Colonic Pseudo-obstruction, Constipation, Abdominal Distension
This is a Rotigotine side effect report of a 74-year-old male patient (weight: NA) from GB. The patient developed the following symptoms/conditions: parkinson^s disease and was treated with Rotigotine (dosage: Dose : 6 Mg) starting Jan 01, 2011. Concurrently used drugs:
  • Rasagiline (Dose: 1 Mg)
Soon after that, the consumer experienced the following of symptoms:
  • Colonic Pseudo-obstruction
  • Constipation
  • Abdominal Distension
The patient was hospitalized. This opens a possibility that Rotigotine could cause colonic pseudo-obstruction and that some male patients may be more susceptible.

Femoral Neck Fracture, Hypophagia, Dyskinesia, Fall
A 79-year-old female patient (weight: NA) from NZ with the following symptoms: parkinson^s disease started Rotigotine treatment (dosage: NA) on Jul 12, 2013. Soon after starting Rotigotine treatment, the consumer experienced several side effects, including:
  • Femoral Neck Fracture
  • Hypophagia
  • Dyskinesia
  • Fall
. Concurrently used drugs:
  • 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)
The patient was hospitalized and became disabled. This finding indicates that some patients can be more vulnerable to developing Rotigotine side effects, such as femoral neck fracture.

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 (dosage: NA), which was started 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)
.When starting to take Rotigotine the consumer reported symptoms, such as:
  • Femoral Neck Fracture
  • Fall
  • Agitation
These side effects may potentially be related to Rotigotine.

Pancytopenia
This is a report of a 82-year-old male patient (weight: NA) from JP, suffering from the following 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). The consumer presented with:
  • Pancytopenia
which developed 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.

Maculopathy, Angiosclerosis, Optic Neuropathy
This report suggests a potential Rotigotine Maculopathy, Angiosclerosis, Optic Neuropathy 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. Soon after starting Rotigotine the patient began experiencing various side effects, including:
  • Maculopathy
  • Angiosclerosis
  • Optic Neuropathy
Drugs used concurrently: NA. Although Rotigotine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as maculopathy, may still occur.

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 commencing Rotigotine, the patient experienced the following unwanted symptoms/side effects:
  • Acute Myocardial Infarction
Although 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.

Craniocerebral Injury
This is a report of a male patient (weight: NA) from CH. The patient developed the following symptoms/conditions: parkinson^s disease,hypertension and was treated with Rotigotine (dosage: In Morning) starting Aug 20, 2012. Concurrently used drugs:
  • Atacand
  • Marcoumar
  • Stalevo
Soon after that, the consumer experienced the following side effects:
  • Craniocerebral Injury
The patient was hospitalized. This opens a possibility that Rotigotine treatment could cause the above reactions, including craniocerebral injury, and some male subjects may be more susceptible.

Restless Legs Syndrome
A 69-year-old female patient (weight: NA) from US with the following symptoms/conditions: restless legs syndrome started Rotigotine treatment (dosage: NA) on NS. Soon after starting Rotigotine treatment, the subject experienced various side effects, including:
  • Restless Legs Syndrome
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Rotigotine.

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Top 10 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

Top 10 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

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

    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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    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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