Summary

Commonly reported side effects of rotigotine 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 Rotigotine

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

• 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 Rotigotine

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]

Oncologic

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