"Sleep disorder drugs (hypnotic and sedative drugs) overview
Insomnia, a disorder in which there is difficulty sleeping, occurs occasionally in most people but usually lasts only a few days. The body then "corrects" itself "...
Requip XL Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Requip XL (ropinirole extended-release tablets) is used to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control. Requip XL is also used to treat restless legs syndrome (RLS). It works by helping restore the balance of a natural substance (dopamine) in the brain. Common side effects include nausea, drowsiness, dizziness, abdominal pain/discomfort, or headache.
The starting dose of Requip XL is 2 mg taken once daily for 1 to 2 weeks, followed by increases of 2 mg/day at 1-week or longer intervals as appropriate, depending on patient response and tolerability, up to a maximum dose of 24 mg/day. Requip XL may interact with cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, medicine for seizures, depression or anxiety, other Parkinson's medications, levodopa, ciprofloxacin, fluvoxamine, metoclopramide, omeprazole, medication used to treat nausea and vomiting, medication to treat mental illness, or estrogen. Tell your doctor all medications you use. Requip XL should be used only when prescribed during pregnancy. It is unknown if this medication passes into breast milk. Breast-feeding while using this drug is not recommended.
Our Requip XL (ropinirole extended-release tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Requip XL in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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);
- 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;
- dizziness, drowsiness;
- sleep problems (insomnia); or
- agitation or anxiety.
Read the entire detailed patient monograph for Requip XL (Ropinirole Extended Release Tablets)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Requip XL Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
You may develop a sudden drop in blood pressure, which can cause dizziness, nausea, and fainting. This is more likely when you are first starting the medication, when your dose is increased, or when you get up suddenly. To lower your risk, get up slowly from a sitting or lying position.
Tell your doctor right away if you have any serious side effects, including: new or worsening uncontrolled movements (dyskinesia), mental/mood changes (such as agitation, confusion, hallucinations), unusual strong urges (such as increased gambling, increased sexual urges).
Some people taking ropinirole have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with ropinirole, including up to 1 year after starting the medication. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Requip XL (Ropinirole Extended Release Tablets)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Requip XL FDA Prescribing Information: Side Effects
The following adverse reactions are described in more detail in the WARNINGS AND PRECAUTIONS section of the label:
- Falling asleep during activities of daily living
- Symptomatic hypotension, hypotension, postural/orthostatic hypotension
- Elevation of blood pressure and changes in heart rate
- Major psychotic disorders
- Events with dopaminergic therapy
- Retinal pathology
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice.
During the premarketing development of REQUIP XL (ropinirole extended release tablets) , patients with advanced Parkinson's disease received REQUIP XL (ropinirole extended release tablets) or placebo as adjunctive therapy in 1 clinical trial. In a second trial, patients with early Parkinson's disease were treated with REQUIP XL (ropinirole extended release tablets) or the immediate-release formulation of REQUIP without L-dopa.
Advanced Parkinson's Disease (With L-dopa)
The most commonly observed adverse reactions ( ≥ 5% and numerically greater than placebo) in the 24-week, double-blind, placebo-controlled trial for the treatment of advanced Parkinson's disease during treatment with REQUIP XL (ropinirole extended release tablets) were, in order of decreasing incidence: dyskinesia, nausea, dizziness, hallucination, somnolence, abdominal pain/discomfort, and orthostatic hypotension.
Approximately 6% of 202 patients treated with REQUIP XL (ropinirole extended release tablets) discontinued treatment due to adverse event(s) compared with 5% of 191 patients who received placebo. The adverse event most commonly causing discontinuation of treatment with REQUIP XL (ropinirole extended release tablets) was hallucination (2%).
Table 2 lists adverse reactions that occurred with a frequency of at least 2% (and were numerically greater than placebo) in patients with advanced Parkinson's disease treated with REQUIP XL (ropinirole extended release tablets) who participated in the 26-week, double-blind, placebo-controlled study. In this study, either REQUIP XL (ropinirole extended release tablets) or placebo was used as an adjunct to L -dopa. Adverse reactions were generally mild or moderate in intensity.
Table 2. Treatment-Emergent Adverse Reaction Incidence in
a Double-Blind, Placebo-Controlled Trial in Advanced Stage Parkinson's Disease
(With L-dopa) (Events ≥ 2% of Patients Treated with REQUIP XL (ropinirole extended release tablets) and > %
|Body System/Adverse Reaction|| REQUIP XL (ropinirole extended release tablets)
(n = 202)
(n = 191)
|Ear and labyrinth disorders|
|Dry mouth||2||< 1|
|Injury, poisoning, and procedural complication|
|Musculoskeletal and connective tissue disorders|
|Nervous system disorders|
Although this study was not designed for optimally characterizing dose-related adverse reactions, there was a suggestion (based upon comparison of incidence of adverse reactions across dose ranges for REQUIP XL (ropinirole extended release tablets) and placebo) that the incidence for dyskinesia, hypertension, and fall was dose-related to REQUIP XL (ropinirole extended release tablets) .
The incidence for many adverse reactions with REQUIP XL (ropinirole extended release tablets) treatment was increased relative to placebo (i.e., REQUIP XL (ropinirole extended release tablets) % Placebo % = treatment difference ≥ 2%) in either the titration or maintenance phases of the study. During the titration phase, an increased incidence (shown in descending order of % treatment difference) was observed for dyskinesia, nausea, abdominal pain/ discomfort, orthostatic hypotension, dizziness, vertigo, hypertension, peripheral edema, and dry mouth. During the maintenance phase, an increased incidence was observed for dyskinesia, nausea, dizziness, hallucination, somnolence, fall, hypertension, abnorma dreams, constipation, chest pain, bronchitis, and nasopharyngitis. Some adverse reactions developing in the titration phase persisted ( ≥ 7 days) into the maintenance phase. These "persistent" adverse reactions included dyskinesia, hallucination, orthostatic hypotension, and dry mouth.
The incidence of adverse reactions was not clearly different between women and men.
Early Parkinson's Disease (Without L -dopa)
The most commonly observed adverse reactions ( > 5%) in the 36-week early Parkinson's disease trial during treatment with REQUIP XL (ropinirole extended release tablets) were, in order of decreasing incidence: nausea (19%), somnolence (11%), abdominal pain/discomfort (7%), dizziness (6%), headache (6%), and constipation (5%). The type of adverse reactions and the frequency (i.e. incidence) with which they occurred were generally similar over the whole treatment period in this study of early Parkinson's disease patients who were initially treated with REQUIP XL (ropinirole extended release tablets) or the immediate-release formulation of REQUIP and subsequently crossed over to treatment with the other formulation.
During the titration phase, an increased incidence with REQUIP XL (ropinirole extended release tablets) compared with the immediate-release formulation of REQUIP (i.e., REQUIP XL (ropinirole extended release tablets) % - REQUIP IR % = treatment difference > 2%), shown in descending order of % treatment difference, was observed for: constipation, hallucination, vertigo, abdominal pain/discomfort, nausea, vomiting, fall, headache, diarrhea, pyrexia, and flatulence. During the maintenance phase, an increased incidence was observed for fall, myalgia, and sleep disorder. Several adverse reactions developing in the titration phase persisted ( > 7 days) into the maintenance phase. These "persistent" adverse reactions included: constipation, hallucination, muscle spasms, flatulence, insomnia, sleep disorder, abdominal pain/discomfort, cough, and nasopharyngitis.
Adverse Reactions Observed During the Clinical Development of the Immediate-Release Formulation of REQUIP for Parkinson's Disease (Advanced and Early)
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug (or of another development program of a different formulation of the same drug) and may not reflect the rates observed in practice.
In patients with advanced Parkinson's disease who were treated with the immediate-release formulation of REQUIP, the most common adverse reactions ( ≥ 5% treatment difference from placebo; presented in order of decreasing treatment difference frequency) were dyskinesia (21%), somnolence (12%), nausea (12%), dizziness (10%), confusion (7%), hallucinations (6%), headache (5%), and increased sweating (5%). In patients with early Parkinson's disease who were treated with the immediate-release formulation of REQUIP, the most common adverse reactions ( > 5% treatment difference from placebo; presented in order of decreasing treatment difference frequency) were nausea (38%), somnolence (34%), dizziness (18%), syncope (11%), viral infection (8%), fatigue (7%), leg edema (6%), asthenia (5%), and dyspepsia (5%).
Read the entire FDA prescribing information for Requip XL (Ropinirole Extended Release Tablets)
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