Ropinirole Side Effects

In Summary

Commonly reported side effects of ropinirole include: syncope, dizziness, drowsiness, dyskinesia, fatigue, nausea, orthostatic hypotension, viral infection, decreased blood pressure, decreased pulse, and increased pulse. Other side effects include: asthenia, confusion, dizziness, lower extremity edema, hallucination, hypotension, systolic hypertension, vertigo, and diaphoresis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ropinirole: oral tablet, oral tablet extended release

Along with its needed effects, ropinirole 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 ropinirole:

• Confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• falling
• nausea
• seeing, hearing, or feeling things that are not there (hallucinations)
• sleepiness or unusual drowsiness
• swelling of the legs
• twisting, twitching, or other unusual body movements
• unusual tiredness or weakness
• worsening of parkinsonism

• Abdominal or stomach pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine
• blurred vision
• burning, pain, or difficulty in urinating
• chest pain
• chills
• cold sweats
• cough
• double vision or other eye or vision problems
• fainting
• fear or nervousness
• feeling of constant movement of self or surroundings
• high or low blood pressure
• irregular or pounding heartbeat
• loss of memory
• mental depression
• pain
• pain in the arms or legs
• pounding in the ears
• rapid weight gain
• sensation of spinning
• slow or fast heartbeat
• sore throat
• sweating
• tightness in chest
• tingling of the hands or feet
• tingling, numbness, or prickly feelings
• trouble in concentrating
• troubled breathing
• unusual weight gain or loss
• vomiting

• Anxiety
• buzzing or ringing in the ears
• changes in vision
• fever
• headache
• joint pain
• loss of bladder control
• muscle cramps, pain, or spasms
• nasal congestion
• runny nose
• sneezing
• trouble with swallowing
• unusual urges

Get emergency help immediately if any of the following symptoms of overdose occur while taking ropinirole:

• Agitation
• grogginess
• increase in unusual body movements, especially of the face or mouth
• increased coughing
• increased sweating
• lack or loss of strength
• nightmares

Some side effects of ropinirole 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:

• Abnormal dreams
• acid or sour stomach
• back pain
• belching
• decrease in sexual desire or performance
• difficulty having a bowel movement (stool)
• dryness of mouth
• flushing
• general feeling of discomfort or illness
• heartburn or gas
• hot flashes
• indigestion
• loss of appetite
• tremor
• weight loss
• yawning

For Healthcare Professionals

Applies to ropinirole: oral kit, oral tablet, oral tablet extended release

Gastrointestinal

Parkinson's disease:
Very common (10% or more): Nausea (up to 60%), vomiting (up to 12%)
Common (1% to 10%): Dry mouth, abdominal pain, anorexia, dyspepsia, flatulence, constipation, diarrhea, dysphagia, increased saliva, heartburn

Restless Leg Syndrome:
Very common (10% or more): Nausea (up to 40%), vomiting (up to 12.9%)
Common (1% to 10%): Diarrhea, dyspepsia, dry mouth, abdominal pain upper
Uncommon (0.1% to 1%):^[Ref]

Nervous system

Parkinson's disease
Very common (10% or more): Dizziness (40%), somnolence (40%), dyskinesia (34%), headache (17%)
Common (1% to 10%): Hyperkinesia, hypesthesia, hypokinesia, paresis, paresthesia, tremor
Uncommon (0.1% to 1%): Sudden onset of sleep, excessive daytime somnolence

Restless Leg Syndrome:
Very common (10% or more): Headache (up to 22.3%), somnolence (12%), dizziness (up to 12.9%)
Common (1% to 10%): Paresthesia, migraine, paradoxical augmentation and rebound of restless leg syndrome^[Ref]

Psychiatric

Parkinson's disease
Very common (10% or more): Hallucination (10%)
Common (1% to 10%): Amnesia, impaired concentration, confusion, amnesia, anxiety, abnormal dreaming, nervousness
Uncommon (0.1% to 1%): Psychotic reactions other than hallucinations, included delirium, delusions, paranoia
Frequency not reported: Aggression
Postmarketing reports: Impulse control disorders included pathological gambling and hypersexuality and increased libido

Restless Leg Syndrome:
Common (1% to 10%): Nervousness
Postmarketing reports: Impulse control disorders included pathological gambling and hypersexuality and increased libido^[Ref]

Cardiovascular

Parkinson's disease:
Very common (10% or more): Syncope (up to 12%)
Common (1% to 10%): Hypertension, hypotension, orthostatic symptoms, chest pain, dependent edema, leg edema, flushing, extrasystoles, atrial fibrillation, palpitation, tachycardia, peripheral ischemia

Restless Leg Syndrome:
Common (1% to 10%): Syncope
Uncommon (0.1% to 1%): Orthostatic hypotension, peripheral edema
Frequency not reported: Hypotension^[Ref]

Immunologic

Common (1% to 10%): Influenza, viral infection^[Ref]

General

The most commonly reported adverse reaction reported in patients with early Parkinson's disease included nausea, somnolence, dizziness, syncope, asthenic conditions, viral infection, leg edema, vomiting, and dyspepsia. Among patients with advance Parkinson's disease, the more commonly reported adverse reactions included dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, sweating, and headache.

The most commonly reported adverse reactions in patients with restless legs syndrome included nausea, vomiting, somnolence, dizziness, and a asthenic condition.^[Ref]

Respiratory

Parkinson's disease
Common (1% to 10%): Yawning, upper respiratory tract infection, dyspnea, bronchitis, pharyngitis, rhinitis, sinusitis

Restless Leg Syndrome:
Very common (10% or more): Upper respiratory infection (10.7%)
Common (1% to 10%): Nasopharyngitis, cough, nasal congestion, rhinitis, sinusitis^[Ref]

Ocular

Parkinson's disease:
Common (1% to 10%): Eye abnormality, abnormal vision, xerophthalmia, diplopia^[Ref]

Metabolic

Parkinson's disease
Common (1% to 10%): Decreased weight^[Ref]

Genitourinary

Common (1% to 10%): Impotence, urinary tract infection, pyuria, urinary incontinence, urinary tract infection^[Ref]

Other

Asthenic conditions include asthenia, fatigue, and/or malaise^[Ref]

Parkinson's disease
Very common (10% or more): Asthenic condition (16%)
Common (1% to 10%): Pain, vertigo

Restless Leg Syndrome:
Very common (10% or more): Fatigue (10.4%)
Common (1% to 10%): Asthenic condition, vertigo
Postmarketing reports:^[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, arthritis, extremity pain, back pain, injury, myalgia^[Ref]

Dermatologic

Common (1% to 10%): Increased sweating^[Ref]

Hematologic

Parkinson's disease
Common (1% to 10%): Anemia^[Ref]

Hepatic

Parkinson's disease
Common (1% to 10%): Increased alkaline phosphatase
Frequency not reported: Increased liver enzymes^[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions including urticarial, angioedema, rash, pruritus^[Ref]

Some side effects of ropinirole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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