Neupro Side Effects

Generic Name: rotigotine

Note: This page contains side effects data for the generic drug rotigotine. It is possible that some of the dosage forms included below may not apply to the brand name Neupro.

It is possible that some side effects of Neupro may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to rotigotine: transdermal patch extended release

As well as its needed effects, rotigotine (the active ingredient contained in Neupro) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking rotigotine, check with your doctor immediately:

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

If any of the following symptoms of overdose occur while taking rotigotine, get emergency help immediately:

Symptoms of overdose
  • Confusion
  • convulsions
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • nausea
  • sweating
  • unusual tiredness or weakness
  • vomiting

Some rotigotine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

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[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

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]

Oncologic

Common (1% to 10%): Basal cell carcinoma[Ref]

References

1. "Product Information. Neupro (rotigotine)." Schwarz Pharma, Mequon, WI.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web4)