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Neupro

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Neupro

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Neupro Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Neupro (rotigotine transdermal system) is a non-ergoline dopamine agonist used to treat early signs and symptoms of Parkinson's disease. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include weight gain; swelling, redness, or itching where the patch was applied; urinating more than usual; runny nose; diarrhea, loss of appetite; feeling dizzy, tired, or weak; mild drowsiness or sleepiness; headache; insomnia; blurred vision; or swelling in your hands or feet.

Neupro is applied once a day. The adhesive side of the transdermal system should be applied to clean, dry, intact healthy skin on the front of the abdomen, thigh, hip, flank, shoulder, or upper arm. The transdermal system should be applied at approximately the same time every day, at a convenient time for the patient. Neupro may interact with other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). Tell your doctor all medications and supplements you use. Neupro may be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. This drug may pass into breast milk and could harm a nursing baby. Consult your doctor before breastfeeding.

Our Neupro (rotigotine transdermal system) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Neupro in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • extreme drowsiness, falling asleep suddenly, even after feeling alert;
  • nausea, sweating, feeling light-headed, fainting;
  • breathing problems;
  • severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure;
  • hallucinations;
  • swelling in your hands or feet; or
  • restless muscle movements in your eyes, tongue, jaw, or neck.

Less serious side effects may include:

  • weight gain;
  • swelling, redness, or itching where the patch was applied.
  • urinating more than usual;
  • runny nose;
  • diarrhea, loss of appetite;
  • feeling dizzy, tired, or weak;
  • mild drowsiness or sleepiness;
  • headache;
  • sleep problems (insomnia);
  • blurred vision; or
  • swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Neupro (Rotigotine Transdermal System) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Neupro Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, loss of appetite, dizziness, drowsiness, lightheadedness, tiredness, trouble sleeping, increased sweating, headache, or redness/itching/swelling at the application site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, agitation, depression, hallucinations), severe dizziness, fainting, compulsive behaviors (such as gambling, increased sexual urges), swelling ankles/feet, unusual weight gain, fast heartbeat, new or worsening uncontrolled movements.

Some people using rotigotine have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with rotigotine, including up to 1 year after starting the medication. Therefore, you should not drive or take part in other possibly dangerous activities until you are certain that this medication will not cause drowsiness or sudden sleep. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy.

You may also develop a sudden drop in blood pressure that can cause dizziness, lightheadedness, nausea, sweating, and fainting. This is more likely when you first start the medication, when your dose is increased, or when you get up suddenly. To reduce your risk, get up slowly when rising from a sitting or lying position.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Neupro (Rotigotine Transdermal System)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Neupro FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in more detail in the WARNINGS AND PRECAUTIONS section of labeling.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the incidence of adverse reactions (number of unique patients experiencing an adverse reaction associated with treatment / total number of patients treated) observed in the clinical trials of a drug cannot be directly compared to incidence of adverse reactions in the clinical trials of another drug and may not reflect the incidence of adverse reactions observed in practice.

Adverse Reactions Incidence in Controlled Clinical Studies in Early-Stage Parkinson's Disease

The safety of Neupro was evaluated in a total of 649 early-stage Parkinson's disease patients who participated in three double-blind, placebo-controlled studies with durations of 3 to 9 months. Additional safety information was collected in short term studies, and two open-label extension studies in patients with early-stage Parkinson's disease.

The incidence of adverse reactions in a randomized, double-blinded, placebo-controlled, fixed-dose trial is shown in Table 1. Incidences for the non-recommended 8 mg/24 hour dose are also shown.

In the double-blind, placebo-controlled, Dose-Response study in patients with early-stage Parkinson's disease, the most commonly observed adverse reactions (> 5 % greater than placebo) for the highest recommended dose of Neupro (6 mg/24 hours) were nausea, vomiting, somnolence, application site reactions, dizziness, anorexia, hyperhidrosis, and insomnia.

In this trial, 12% of patients treated with the highest, recommended Neupro dose (6 mg/24 hours) discontinued treatment because of adverse reactions, compared with 6% of patients who received placebo.

Table 1 : Incidence of Treatment-Emergent Adverse Reactions in Placebo-Controlled, Trial of Patients with Early-Stage Parkinson's Disease (Dose-Response Study) Where Incidence Was ≥ 2 % in 6 mg/24 hours Neupro Group and Greater Than the Incidence in Placebo-Treated Patients

Adverse Reactions Placebo
N=64 %
Neupro dose
2 mg/24h
N=67
%
4 mg/24h
N=64
%
6 mg/24h
N=65
%
8 mg/24h
N=70
%
Ear and labyrinth disorders
  Tinnitus 0 0 2 3 0
Gastrointestinal disorders
  Nausea* 13 34 38 48 41
  Vomiting* 3 10 16 20 11
  Anorexia 0 0 2 8 4
  Dyspepsia 0 2 2 3 0
General disorders and administration site conditions
  Application and instillation site reactions 19 24 21 34 46
  Fatigue 3 8 18 6 13
  Oedema peripheral* 2 2 3 3 4
Infections and infestations
  Upper respiratory tract infection 0 3 5 2 0
  Sinusitis 0 2 0 2 1
Injury, poisoning and procedural complications
  Contusion* 0 2 0 2 4
Investigations
  White blood cells urine positive 2 3 3 3 1
  Electrocardiogram T wave abnormal 0 0 2 3 0
  Weight decreased* 0 0 0 2 3
Metabolism and nutrition disorders
  Anorexia 0 2 2 6 1
  Decreased appetite* 0 0 0 3 3
Musculoskeletal and connective tissue disorders
  Muscle spasms* 2 3 2 3 4
Nervous system disorders
  Dizziness 11 21 14 22 20
  Dizziness postural 0 2 2 2 1
  Somnolence* 3 12 14 19 20
  Lethargy 0 2 2 2 1
  Balance disorder 0 0 2 3 0
Psychiatric disorders
  Insomnia 6 5 10 11 7
  Early morning awakening* 0 0 0 2 3
  Abnormal dreams* 0 2 5 3 7
  Depression 0 5 3 2 0
Reproductive system and breast disorders
  Erectile dysfunction* 0 0 0 2 3
Respiratory, thoracic and mediastinal disorders
  Pharyngolaryngeal pain 0 2 2 2 0
  Hiccups* 0 2 2 2 3
Skin and subcutaneous tissue disorders
  Hyperhidrosis 3 3 3 11 3
  Erythema* 3 3 6 5 6
  Rash pruritic* 0 0 0 2 3
*Dose-related
HLT=high level term; MedDRA=Medical Dictionary for Regulatory Activities; PT=preferred term; SOC=system organ class; TEAEs=treatment-emergent adverse events

The incidence of certain adverse reactions with Neupo treatment was notably increased compared to placebo treatment (i.e., Neupro % - placebo % = ≥5 %) in either the titration or maintenance phases of the Dose-Response trial. During the titration phase, an increased incidence ( in descending order of % treatment difference) was observed for nausea, somnolence, vomiting, application site reactions (ASRs), dizziness, sweating increased, anorexia and vision abnormal. During the maintenance phase, an increased incidence was observed for nausea, and ASRs. Some adverse reactions developing in the titration phase persisted ( ≥7 days) into the maintenance phase. These “persistent” adverse reactions included ASRs, anorexia, somnolence, nausea, and vision abnormal.

Adverse Reactions Incidence in Controlled Clinical Studies in Advanced-Stage Parkinson's Disease

The safety evaluation of Neupro was based on a total of 672 Neupro-treated subjects with advanced-stage Parkinson's disease who participated in 3 double-blind, placebo-controlled studies (2 fixed-dose trials and one flexible dose trial) with durations of 3 to 7 months. Patients received concomitant levodopa in these studies. Additional safety information was collected in earlier short-term studies, and 2 open-label extension studies in subjects with advanced-stage Parkinson's disease.

The incidence of adverse reactions in a randomized, double-blinded, placebo-controlled, fixed-dose trial is shown in Table 2. Incidences for the non-recommended 12 mg/24 hour dose are also shown.

In the Dose-Response, placebo controlled trial for advanced-stage Parkinson's disease, the most common adverse reactions (> 5 % greater than placebo) for the highest recommended dose of Neupro (8 mg) were application site reactions, nausea, somnolence, and headache.

In this trial, approximately 15 % of patients treated with the highest, recommended Neupro dose (8 mg/24 hours) discontinued treatment because of adverse reactions, compared with 9 % of patients who received placebo.

Table 2: Incidence of Treatment-Emergent Adverse Reactions in Placebo-Controlled, Trial of Patients with Advanced-Stage Parkinson's Disease (Dose-Response Study) Where Incidence Was ≥ 2 % in 8 mg/24 hours Neupro Group and Greater Than the Incidence in Placebo-Treated Patients

Adverse Reaction Placebo
N=120
%
Neupro dose
8 mg/24h
N=118
%
12 mg/24h
N=111
%
Gastrointestinal disorders
Nausea 19 28 22
Vomiting 6 10 8
Constipation 6 9 5
Diarrhea 5 7 5
General disorders and administration site conditions
Application and instillation site reactions a * 13 36 46
Edema peripheral* 1 9 14
Asthenia 3 4 3
Musculoskeletal and connective tissue disorders
Musculoskeletal pain 1 2 2
Arthralgia 7 11 8
Nervous system disorders
Somnolence 28 32 32
Dizziness 15 23 14
Dyskinesia* 7 14 17
Headache 8 10 8
Paraesthesias/Dysesthesias* 3 5 6
Tremor 3 4 3
Psychiatric disorders
Disturbances in initiating and maintaining sleep a * 6 9 14
Hallucinations * 3 7 14
Nightmare* 2 3 5
Respiratory, thoracic and mediastinal disorders
Cough 1 3 3
Nasal congestion 0 3 3
Sinus congestion 0 3 2
Skin and subcutaneous tissue disorders
Hyperhidrosis 0 3 1
Erythema 1 3 2
Vascular disorders
Hypertension* 0 3 5
*Dose-related
HLT=high level term; MedDRA=Medical Dictionary for Regulatory Activities; PT=preferred term; SOC=system organ class; TEAEs=treatment-emergent adverse events
aThe following selected HLTs were considered and included, if applicable: application and instillation site reactions, asthenic conditions, and disturbances in initiating and maintaining sleep

The incidence of certain adverse reactions with Neupo treatment was notably increased compared to placebo treatment (i.e., Neupro % - placebo % = ≥ 5 %) in either the titration or maintenance phases of the Dose-Response trial. During the titration phase, an increased incidence (in descending order of % treatment difference) was observed for nausea, hallucinations, constipation, dyskinesia, dizziness. During the maintenance phase, an increased incidence was observed for ASRs, peripheral edema, and dyskinesia. Some adverse reactions developing in the titration phase persisted ( ≥ 7 days) into the maintenance phase. A notably “persistent” adverse reaction was ASRs.

Adverse Reactions Incidence in Controlled Clinical Studies in Restless Legs Syndrome

The safety evaluation of rotigotine was based on a total of 745 Neupro-treated subjects with RLS who participated in 2 double-blind, placebo-controlled studies with maintenance durations of 6 months. Additional safety information was collected in earlier short term studies, and 3 open-label extension studies in subjects with RLS.

The incidence of adverse reactions in two randomized, double-blinded, placebo-controlled, fixed-dose trials are shown in Table 3.

In the two randomized, double-blinded, placebo-controlled, fixed-dose trials for RLS, the most common adverse reactions (> 5 % greater than placebo) for the highest recommended dose of Neupro (3 mg) were application site reactions, nausea, somnolence, and headache.

In the two Dose-Response, placebo controlled trials, 24 % of Neupro-treated patients treated with the highest recommended dose (3 mg) discontinued treatment because of adverse reactions, compared with 3 % of patients who received placebo.

Table 3 : Incidence of Treatment-Emergent Adverse Reactions in Placebo-Controlled, Trial of Patients with Restless Legs Syndrome (North American and Foreign Multinational Studies) Where Incidence Was ≥ 2 % in 2 mg or 3 mg/24 hours Neupro Groups and Greater Than the Incidence in Placebo-Treated Patients

Adverse Reaction Placebo
N=217
Neupro Dose
0.5 mg/24h
N=99
%
1 mg/24h
N=215
%
2 mg/24h
N=211
%
3 mg/24h
N=220
%
Ear and labyrinth disorders
Vertigo 1 0 4 3 1
Gastrointestinal disorders
Nausea 10 18 15 23 21
Dry mouth* 4 3 3 3 7
Constipation 3 6 3 2 5
Vomiting* 1 2 2 4 4
Dyspepsia* 1 2 1 2 3
General disorders and administration site conditions
Application and instillation site reactions a * 4 23 27 38 43
Asthenic conditions a * 8 11 7 14 12
Infections and infestations
Nasopharyngitis 7 5 10 7 8
Sinusitis* 1 2 1 2 3
Investigations
Serum ferritin decreased* 1 2 1 1 2
Musculoskeletal and connective tissue disorders
Muscle spasms 1 3 1 4 1
Nervous system disorders
Headache 11 21 15 18 16
Somnolence* 4 8 5 8 10
Dizziness 6 7 5 9 6
Psychiatric disorders
Disturbances in initiating and/or maintaining sleep a * 3 2 4 3 10
Sleep disorder* 1 0 2 3 3
Abnormal dreams* 0 2 1 2 3
Sleep attacks* 0 0 1 0 2
Skin and subcutaneous tissue disorders
Pruritus 3 9 4 3 7
Hyperhidrosis* 2 1 3 5 3
Erythema* 1 1 1 0 2
Vascular disorders
Hypertension* 0 3 1 1 4
Hot flush 1 4 1 3 0
*Dose-related
HLT=high level term; MedDRA=Medical Dictionary for Regulatory Activities; PT=preferred term; SOC=system organ class
aThe following selected HLTs were considered and included, if applicable: application and instillation site reactions, asthenic conditions (i.e., asthenia, malaise, fatigue), and disturbances in initiating and maintaining sleep.

The incidence of certain adverse reactions with Neupo treatment was notably increased compared to placebo treatment (i.e., Neupro % - placebo % = ≥5 %) in either the titration or maintenance phases of the Dose-Response trial. During the titration phase, an increased incidence (in descending order of % treatment difference) was observed for ASRs, and disturbances in initiating and/or maintaining sleep. During the maintenance phase, an increased incidence was observed for ASRs. Some adverse reactions developing in the titration phase persisted (> 7 days) into the maintenance phase. These “persistent” adverse reactions were ASRs, nausea, and disturbances in initiating and/or maintaining sleep.

Laboratory Changes

Some clinical laboratory analytes were abnormal for patients treated with the highest recommended Neupro dose in the dose-response trials for patients with early-stage and advanced-stage Parkinson's disease and with RLS.

There was a treatment difference (Neupro % - placebo %) of 6 % for decreased hemoglobin (below the normal reference range) and of 3 % for decreased hematocrit (below the normal reference range) in patients with early-stage Parkinson's disease. There was a treatment difference of 4 % for a decreased hemoglobin (below the normal reference range) and of 3 % for decreased hematocrit (below the normal reference range) in patients with advanced-stage Parkinson's disease. There was a treatment difference of 3 % for a decreased hemoglobin (below the normal reference range) in patients with RLS. There was also a treatment difference of 2 % for markedly decreased hemoglobin and hematocrit in patients with advanced Parkinson's disease and of 1 % for markedly decreased hematocrit in patients with RLS.

There was a treatment difference of 9 % for increased serum BUN (above the normal reference range) in patients with early-stage Parkinson's disease. There was a treatment difference of 1 % for markedly increased serum BUN in patients with advanced-stage Parkinson's disease.

There was a treatment difference of 9 % for decreased serum glucose (below the normal reference range) in patients with early-stage Parkinson's disease and of 3 % in patients with advanced-stage Parkinson's disease. There was a treatment difference of 1 % for markedly decreased serum glucose in patients with advanced-stage Parkinson's disease.

Read the entire FDA prescribing information for Neupro (Rotigotine Transdermal System) »

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Neupro - User Reviews

Neupro User Reviews

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Here is a collection of user reviews for the medication Neupro sorted by most helpful. Patient Discussions FAQs

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