Ropinirole Side Effects
It is possible that some side effects of ropinirole 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 ropinirole: oral tablet, oral tablet extended release
As well as its needed effects, ropinirole may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking ropinirole, check with your doctor immediately:More common
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- seeing, hearing, or feeling things that are not there (hallucinations)
- sleepiness or unusual drowsiness
- swelling of legs
- twisting, twitching, or other unusual body movements
- unusual tiredness or weakness
- worsening of parkinsonism
- Abdominal pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in urine
- blurred vision
- burning, pain, or difficulty in urinating
- chest pain
- cold sweats
- double vision or other eye or vision problems
- 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 in arms or legs
- pounding in the ears
- rapid weight gain
- sensation of spinning
- shortness of breath
- slow or fast heartbeat
- sore throat
- tightness in chest
- tingling of hands or feet
- tingling, numbness, or prickly feelings
- trouble in concentrating
- troubled breathing
- unusual weight gain or loss
- buzzing or ringing in the ears
- changes in vision
- joint pain
- loss of bladder control
- muscle cramps, pain, or spasms
- nasal congestion
- runny nose
- trouble in swallowing
- unusual urges
If any of the following symptoms of overdose occur while taking ropinirole, get emergency help immediately:Symptoms of overdose
- increase in unusual body movements, especially of the face or mouth
- increased coughing
- increased sweating
- lack or loss of strength
Some ropinirole 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:Less common
- Abnormal dreams
- acid or sour stomach
- back pain
- decrease in sexual desire or performance
- difficulty having a bowel movement (stool)
- dryness of mouth
- general feeling of discomfort or illness
- heartburn or gas
- hot flashes
- loss of appetite
- weight loss
For Healthcare Professionals
Applies to ropinirole: oral kit, oral tablet, oral tablet extended release
Gastrointestinal side effects have included nausea (12% to 60%), vomiting (12%), abdominal pain (6% to 7%), constipation (5% to 6%), dyspepsia (4% to 5%), diarrhea (5%), anorexia (4%), and flatulence (3%). These side effects may be decreased by taking the drug with food. Gastroesophageal reflux disease, stomach discomfort, abdominal adhesions, abdominal discomfort, abdominal distension, abdominal pain lower, duodenal ulcer, dysphagia, eructation, gastric disorder, gastric hemorrhage, gastric polyps, gastric ulcer, gastrointestinal pain, gastrointestinal infection, hemorrhoids, hiatus hernia, intestinal obstruction, irritable bowel syndrome, loose stools, mouth ulceration, pancreatitis acute, peptic ulcer, rectal hemorrhage, and reflux esophagitis have also been reported. Biliary pain, hemorrhagic gastritis, hematemesis, and salivary duct obstruction have been reported rarely.
Nervous system side effects have included dyskinesia (21% to 34%), dizziness (6% to 26%), headache (5% to 17%), falls (10%), paresthesia (5%), hypokinesia (5%), hypesthesia (4%), hyperkinesia (2%) and vertigo (2%). Neuralgia, involuntary muscle contractions, hypertonia, dysphonia, abnormal coordination, extrapyramidal disorder, migraine, choreoathetosis, coma, stupor, aphasia, convulsions, hypotonia, peripheral neuropathy, and paralysis have also been reported. Grand mal convulsions, hemiparesis, and hemiplegia have been reported rarely.
Sixty cases of sudden onset of sleep have been reported. Two of these cases have been reported to have lead to fatal car accidents. Patients should be advised that sudden sleep has been reported without warning signs. Patients should be warned against driving or performing other activities which may put the patient or others in danger if drowsiness or sudden sleep were to occur. If drowsiness or sudden sleep does occur, patients should be advised that they should immediately contact their physicians.
Psychiatric side effects have included somnolence (11% to 40%), confusion (5% to 9%), hallucination (5% to 6%), amnesia (3%), yawning (3%), and impaired concentration (2%). Hallucinations appear to be dose related. Anxiety, depression, irritability, sleep disorder, abnormal dreams, agitation, bruxism, confusional state, depressed mood, disorientation, early morning awakening, libido decreased, loss of libido, mood swings, nervousness, nightmare, panic attack, manic reaction, somnambulism, aggressive reaction, neurosis, stress symptoms, and tension have also been reported. Suicide attempt has been reported rarely. Impulse control symptoms, pathological (compulsive) gambling, increased libido including hypersexuality have been reported principally in Parkinson's disease patients treated with dopaminergic drugs, especially at higher doses.
Cardiovascular effects have included syncope (11% to 12%), orthostatic symptoms (6%), hypertension (5%), hypotension (2%), palpitation (3%), tachycardia (2%), atrial fibrillation (2%), and extrasystoles (2%). Peripheral ischemia, atherosclerosis, acute coronary syndrome, angina pectoris, angina unstable, bradycardia, cardiac failure, cardiovascular disorder, coronary artery disease, myocardial infarction, sick sinus syndrome, circulatory collapse, and thrombosis have also been reported.
Immunologic side effects have included viral infection (8% to 11%).
General side effects have included fatigue (7% to 11%), pain (8%), leg edema (6% to 7%), asthenia (5% to 6%), dependent edema (6%), and chest pain (4%). Hematoma, flushing, and varicose vein have also been reported.
Respiratory side effects have included pharyngitis (6%), rhinitis (4%), sinusitis (4%), bronchitis (3%), cough (3%), and dyspnea (3%). Nasal congestion, asthma, epistaxis, laryngitis, pneumonia, respiratory tract infection, tonsillitis, pleurisy, and pulmonary edema have also been reported.
Ocular side effects have included abnormal vision (6%), eye abnormality (3%), diplopia (2%), and xerophthalmia (2%). Conjunctivitis, abnormal lacrimation, blepharitis, glaucoma, abnormal accommodation, blepharospasm, eye pain, photophobia, conjunctival hemorrhage, eye irritation, keratoconjunctivitis sicca, vision blurred, visual acuity reduced, and visual disturbance have also been reported. Scotoma has been reported rarely.
Metabolic side effects have included increases in alkaline phosphatase and BUN. Weight decrease/ increase, hypoglycemia, increased LDH, hyperphosphatemia, hyperuricemia, diabetes mellitus, glycosuria, hypokalemia, hypercholesterolemia, hyperkalemia, acidosis, hyponatremia, thirst, increased CPK, and dehydration. Hypochloremia has been reported rarely.
Genitourinary side effects have included Impotence (3%). Amenorrhea, vaginal hemorrhage, vaginal infection, penile disorder, prostatic disorder, balanoposthitis, epididymitis, perineal pain, dysuria, micturition frequency, albuminuria, nocturia, polyuria, and renal calculus have also been reported. Breast enlargement, mastitis, uterine hemorrhage, ejaculation disorder, Peyronie's disease, pyelonephritis, acute renal failure, and uremia have been reported rarely.
Other side effects have included increased sweating (5%).
When ropinirole was administered concomitantly with L-dopa to patients with advanced Parkinson's disease, dyskinesia (13% to 34%), nausea (11% to 30%), dizziness (8% to 26%), somnolence (7% to 20%), headache (17%), hallucinations (8% to 10%), falls (10%), abdominal pain (6% to 9%), confusion (9%), increased sweating (7%), vomiting (7%), increased drug level (7%), arthralgia (7%), tremor (6%), anxiety (2% to 6%), urinary tract infection (6%), constipation (4% to 6%), dry mouth (2% to 5%), pain (5%), hypokinesia (5%), paresthesia (5%), diarrhea (3% to 5%), amnesia (5%), nervousness (5%), orthostatic hypotension (5%), peripheral edema (4%), vertigo (4%), back pain (3%), hypertension (3%), hypotension (2%), insomnia, injury, aggravated Parkinsonism, viral infection, abnormal dreams, bronchitis, vertigo, pyrexia, flatulence, nasopharyngitis, myalgia, and sleep disorder have been reported.
Musculoskeletal side effects have included arthralgia, myalgia, muscle spasms, neck pain, osteoarthritis, tendonitis, bone pain, bursitis, groin pain, intervertebral disc degeneration, intervertebral disc protrusion, joint stiffness, joint swelling, localized osteoarthritis, muscle contracture, muscle twitching, osteoporosis, rotator cuff syndrome, sacroiliitis, synovitis, polymyalgia rheumatica, skeletal pain, torticollis, and pain in extremity. Dupuytren's contracture requiring surgery has been reported rarely.
Dermatologic side effects have included hyperhidrosis, night sweats, and rash. Pruritus, dermatitis, eczema, skin ulceration, alopecia, acne, actinic keratosis, skin hypertrophy, skin discoloration, urticaria, fungal dermatitis, furunculosis, hyperkeratosis, photosensitivity reaction, psoriasis, maculopapular rash, psoriasiform rash, and seborrhea have been reported infrequently.
Hematologic side effects have been reported rarely. These have included purpura, thrombocytopenia, hematoma, vitamin B12 deficiency, hypochromic anemia, eosinophilia, leukocytosis, leukopenia, lymphocytosis, lymphopenia, and lymphedema.
Endocrine side effects have infrequently included hypothyroidism, gynecomastia, and hyperthyroidism. Goiter and SIADH have been reported rarely.
Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis, and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents. Complete resolution of symptoms did not always occur upon discontinuation of the drug.
Other side effects have included fibrotic complications, including pleural effusions, pleural fibrosis, interstitial lung disease, and cardiac valvulopathy, although causal relationship was not established.
Hepatic side effects have included cholecystitis colitis, cholelithiasis, ischemic hepatitis, and increased hepatic enzymes.
Oncologic side effects have included malignant breast neoplasm, bladder, carcinoma, benign brain neoplasm, esophageal carcinoma, malignant laryngeal neoplasm, lipoma, rectal carcinoma, and uterine neoplasm. Anaplastic thyroid cancer, angiomyolipoma, basal cell carcinoma, gastric cancer, gastrointestinal stromal tumor, malignant melanoma, prostate cancer, skin papilloma, squamous cell carcinoma, and uterine leiomyoma have also been reported.
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