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Note: This document contains side effect information about rotigotine. Some of the dosage forms listed on this page may not apply to the brand name Neupro.
Common side effects of Neupro include: application site reaction, insomnia, nausea, and vomiting. Other side effects include: dizziness, dyspepsia, increased blood pressure, increased heart rate, orthostatic hypotension, and orthostatic dizziness. See below for a comprehensive list of adverse effects.
Applies to rotigotine: transdermal patch extended release
Along with its needed effects, rotigotine (the active ingredient contained in Neupro) 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:
Get emergency help immediately if any of the following symptoms of overdose occur while taking rotigotine:
Symptoms of overdose
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:
Applies to rotigotine: transdermal film extended release
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
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.
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
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.
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
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.
Very common (10% or more): Arthralgia (up to 11%)
Common (1% to 10%): Muscle spasms
Frequency not reported: Elevated creatine phosphokinase
Common (1% to 10%): Sinus congestion, nasal congestion, cough, nasopharyngitis, hiccups
Common (1% to 10%): Visual disturbances
Uncommon (0.1% to 1%): Blurred vision, visual impairment, photopsia
Common (1% to 10%): WBC in urine
Uncommon (0.1% to 1%): Erectile dysfunction
Common (1% to 10%): Hypersensitivity including tongue edema and lip edema
Uncommon (0.1% to 1%): Hepatic enzyme increases (ALT, AST, GGT)
Common (1% to 10%): Anorexia, increased weight, decreased weight
Frequency not reported: Decreased serum glucose
Frequency not reported: Elevated BUN
Common (1% to 10%): Decreased serum ferritin
Frequency not reported: Decreased hemoglobin/hematocrit
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
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
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
Asthenic conditions included asthenia, malaise, and fatigue.
Very common (10% or more): Fatigue (up to 18%), asthenic conditions (up to 14%)
Common (1% to 10%): Tinnitus, vertigo
Common (1% to 10%): Menstrual disorder, sexual desire disorder
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.
Common (1% to 10%): Basal cell carcinoma
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