Neupro Side Effects

Generic name: rotigotine

Medically reviewed by Philip Thornton, DipPharm. Last updated on Oct 14, 2022.

Note: This document contains side effect information about rotigotine. Some dosage forms listed on this page may not apply to the brand name Neupro.

Summary

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. Continue reading for a comprehensive list of adverse effects.

Applies to rotigotine: transdermal patch extended release.

Serious side effects of Neupro

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:

More common

Burning, itching, redness, skin rash, swelling, or soreness at the application site
swelling of the hands, ankles, feet, or lower legs

Less common

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

Sleepiness or unusual drowsiness

Less common

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.

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]

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

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]

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]

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

Asthenic conditions included asthenia, malaise, and fatigue.^[Ref]

Very common (10% or more): Fatigue (up to 18%), asthenic conditions (up to 14%)

Common (1% to 10%): Tinnitus, vertigo^[Ref]

Endocrine

Common (1% to 10%): Menstrual disorder, sexual desire disorder^[Ref]

General

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]