Requip Side Effects

Generic name: ropinirole

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

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

For the Consumer

Applies to ropinirole: oral tablet, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking ropinirole (the active ingredient contained in Requip) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• feeling like you might pass out;

• fever, stiff muscles, confusion, sweating, fast or uneven heartbeats (especially if you stop taking ropinirole or use a lower dose);

• hallucinations;

• tremors (uncontrolled shaking); or

• tight feeling in your chest, trouble breathing.

Call your doctor promptly if you fall asleep during a daily activity, if you faint, or if you have hallucinations (hearing or seeing something that is not there). Your doctor may want you to stop taking ropinirole, or take a lower dose.

Less serious side effects may occur, such as:

• mild nausea, vomiting, stomach pain, or loss of appetite;

• worsened RLS symptoms early in the morning;

• diarrhea or constipation;

• dry mouth, sweating;

• headache;

• dizziness, drowsiness;

• sleep problems (insomnia); or

• agitation or anxiety.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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

Gastrointestinal

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

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.

Psychiatric

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

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

Immunologic side effects have included viral infection (8% to 11%).

General

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

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

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

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

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

Other side effects have included increased sweating (5%).

When ropinirole (the active ingredient contained in Requip) 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

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

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

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

Endocrine side effects have infrequently included hypothyroidism, gynecomastia, and hyperthyroidism. Goiter and SIADH have been reported rarely.

Other

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

Hepatic side effects have included cholecystitis colitis, cholelithiasis, ischemic hepatitis, and increased hepatic enzymes.

Oncologic

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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