Neupro Side Effects
Generic name: rotigotine
Note: This document provides detailed information about Neupro.
Applies to rotigotine: transdermal patch extended release Side Effects associated with rotigotine. Some dosage forms listed on this page may not apply specifically to the brand name Neupro.
Applies to rotigotine: transdermal patch extended release.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
This medicine may cause some people to become dizzy, drowsy, lightheaded, or faint. People using rotigotine (the active ingredient contained in Neupro) have reported falling asleep without warning during activities of daily living, including driving, which sometimes resulted in accidents. This may happen as late as one year after taking the medicine. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think well. If these side effects are especially bothersome, check with your doctor.
This medicine may cause changes in your blood pressure or heart rate. Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.
This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors, including confusion, delusions, feeling aggressive or hostile, or seeing, hearing, or feeling things that are not there (hallucinations). If you or your caregiver notice any of these side effects, tell your doctor right away.
Some people who have used this medicine had unusual changes in their thoughts or behavior, including an urge to gamble, spend money, binge eat, or an increased sex drive. Talk with your doctor if this is a concern for you.
This medicine may cause fluid retention (edema) in some patients. Tell your doctor right away if you have bloating or swelling of the face, arms, hands, lower legs, or feet, tingling of the hands or feet, or unusual weight gain or loss.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
The patch contains aluminum, which can cause skin burns when used during certain procedures such as magnetic resonance imaging (MRI) or cardioversion. To prevent skin burns, make sure the patch is removed before having these procedures.
Heat may cause too much of the rotigotine to pass through your skin. Do not expose the patch to direct sources of heat, such as heating pads, electric blankets, heat lamps, saunas, hot tubs, heated water beds, or direct sunlight. Direct sunlight may cause your skin to change color.
Tell your doctor if you develop a skin rash or irritation from the patch that lasts longer than a few days, becomes more severe, or spreads to areas outside the application site.
Do not change your dose or stop using this medicine suddenly without first asking your doctor. You will need to slowly decrease your dose before stopping it completely. Stopping this medicine suddenly may cause anxiety, confusion, depression, fever, lack of feeling or emotion, severe muscle stiffness, sweating, trouble sleeping, uncaring, or unusual tiredness or weakness.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Serious side effects of Neupro
Along with its needed effects, rotigotine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking rotigotine:
More common side effects
- burning, itching, redness, skin rash, swelling, or soreness at the application site
- swelling of the hands, ankles, feet, or lower legs
Less common side effects
- bladder pain
- bloody or cloudy urine
- blurred vision or other changes in vision
- difficult, burning, or painful urination
- dizziness
- frequent urge to urinate
- headache
- lower back or side pain
- nervousness
- pounding in the ears
- seeing, hearing, or feeling things that are not there
- slow or fast heartbeat
Incidence not known
- anxiety
- dark-colored urine
- discouragement
- feeling sad or empty
- fever
- irritability
- lack of appetite
- lack of feeling or emotion
- loss of interest or pleasure
- muscle pain, stiffness, cramps, or spasms
- sweating
- tiredness
- trouble concentrating
- trouble sleeping
- uncaring
Get emergency help immediately if any of the following symptoms of overdose occur while taking rotigotine:
Symptoms of overdose
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- nausea
- seizures
- sweating
- unusual tiredness or weakness
- vomiting
Other side effects of Neupro
Some side effects of rotigotine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- sleepiness or unusual drowsiness
Less common side effects
- acid or sour stomach
- belching
- difficulty having a bowel movement (stool)
- difficulty with moving
- dreaming abnormal
- dry mouth
- feeling of constant movement of self or surroundings
- heartburn
- indigestion
- loss of appetite
- muscle pain or stiffness
- pain in the joints
- sensation of spinning
- sleeplessness
- stomach discomfort, upset, or pain
- trouble sleeping
- unable to sleep
- weight loss
For healthcare professionals
Applies to rotigotine: transdermal film extended release.
General adverse events
The most common adverse reactions experienced among patients with Parkinson's disease included nausea, vomiting, somnolence, application site reactions, dizziness, anorexia, disturbances in initiating and maintaining sleep, hyperhidrosis, visual disturbances, peripheral edema, and dyskinesia. For patients with Restless Legs Syndrome, the most common adverse reactions included application site reactions, nausea, disturbances in initiating and maintaining sleep, somnolence, and headache.[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (up to 41%), vomiting (up to 20%),
- Common (1% to 10%): Dyspepsia, constipation, diarrhea, dry mouth,
- Uncommon (0.1% to 1%): Abdominal pain[Ref]
Nausea and vomiting may occur at the beginning of therapy but these are usually mild or moderate in intensity and transient even if treatment is continued.[Ref]
Nervous system
- Very common (10% or more): Somnolence (up to 32%), dizziness (up to 23%), dyskinesia (up to 14%), headache (up to 21%)
- Common (1% to 10%): Balance disorder, paresthesia, tremor, hypoesthesia, sleep attacks
- Rare (less than 0.1%): Convulsion
- Postmarketing reports: Dropped head syndrome[Ref]
In clinical trials, 2% of patients receiving maximum doses of this drug for restless legs syndrome reported sleep attacks compared with 0% of patients receiving placebo.[Ref]
Musculoskeletal
- Very common (10% or more): Arthralgia (up to 11%)
- Common (1% to 10%): Muscle spasms
- Frequency not reported: Elevated creatine phosphokinase[Ref]
Respiratory
- Common (1% to 10%): Sinus congestion, nasal congestion, cough, nasopharyngitis, hiccups[Ref]
Ocular
- Common (1% to 10%): Visual disturbances
- Uncommon (0.1% to 1%): Blurred vision, visual impairment, photopsia[Ref]
Genitourinary
- Common (1% to 10%): WBC in urine
- Uncommon (0.1% to 1%): Erectile dysfunction[Ref]
Hypersensitivity
- Common (1% to 10%): Hypersensitivity including tongue edema and lip edema[Ref]
Hepatic
- Uncommon (0.1% to 1%): Hepatic enzyme increases (ALT, AST, GGT)[Ref]
Metabolic
- Common (1% to 10%): Anorexia, increased weight, decreased weight
- Frequency not reported: Decreased serum glucose[Ref]
Renal
- Frequency not reported: Elevated BUN[Ref]
Hematologic
- Common (1% to 10%): Decreased serum ferritin
- Frequency not reported: Decreased hemoglobin/hematocrit[Ref]
Dermatologic
- Very common (10% or more): Application site reactions (up to 46%), hyperhidrosis (up to 11%)
- Common (1% to 10%): Erythema, pruritus,
- Uncommon (0.1% to 1%): Contact dermatitis
- Rare (less than 0.1%): Generalized rash[Ref]
Application site reactions (ASRs) exhibited a dose-dependent relationship for all doses in patients with both Parkinson's disease and restless legs syndrome. Reactions included localized erythema, edema, or pruritus, generally limited to the patch area; although generalized skin reactions such as allergic rash, including erythematous, macular-papular rash, or pruritus were reported at a lower incidence. Rotation of application sites has been shown to reduce the incidence of ASRs.
When applied as instructed, 34.2% (n=748) of patients experienced ASR; the majority were mild or moderate in intensity. Discontinuation occurred in 7.2% of patients[Ref]
Psychiatric
- Very common (10% or more): Disturbances in initiating and maintaining sleep (up to 14%), hallucinations (up to 13%)
- Common (1% to 10%): Abnormal dreams, nightmare, irritability, sleep disorder, depression, impulse-control disorders
- Uncommon (0.1% to 1%): Obsessive-compulsive disorder, disorientation, agitation
- Rare (less than 0.1%): Aggressive behavior, binge eating, delusion, delirium[Ref]
Other
- Very common (10% or more): Fatigue (up to 18%), asthenic conditions (up to 14%)
- Common (1% to 10%): Tinnitus, vertigo[Ref]
Asthenic conditions included asthenia, malaise, and fatigue.[Ref]
Endocrine
- Common (1% to 10%): Menstrual disorder, sexual desire disorder[Ref]
Cardiovascular
- Very common (10% or more): Peripheral edema (up to 14%), orthostatic hypotension (up to 32%)
- Common (1% to 10%): Abnormal ECG T wave, first degree AV block, hypertension, palpitations
- Uncommon (0.1% to 1%): Atrial fibrillation
- Rare (less than 0.1%): Supraventricular tachycardia[Ref]
The incidence of significant decreases in blood pressure or orthostatic hypotension increased during periods of dose escalation and titration. In patients taking maximum recommended doses, orthostatic hypotension occurred (compared to placebo) at 29% (vs 11%), 27% (vs 23%), and 8% (vs 7%), in those with early stage Parkinson's disease (PD), advanced-stage PD, and restless legs syndrome, respectively.
The incidence of peripheral edema was 3% and 2% for patients with early-stage PD compared with 9% and 1% for patients with advanced-stage PD receiving drug and placebo, respectively.[Ref]
Oncologic
- Common (1% to 10%): Basal cell carcinoma[Ref]
See also:
Benztropine
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Sinemet
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Cogentin
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Mirapex
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Exelon
Exelon (rivastigmine) is used to treat dementia caused by Alzheimer's or Parkinson's disease ...
Horizant
Horizant (gabapentin enacarbil) is used to treat restless legs syndrome and nerve pain caused by ...
Gocovri
Gocovri (amantadine) is used in the treatment of Parkinson's disease. Includes Gocovri side ...
Inbrija
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Gabapentin enacarbil
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. (2007) "Product Information. Neupro (rotigotine)." Schwarz Pharma
3. Cerner Multum, Inc. "Australian Product Information."
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Further information
Neupro side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.