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Requip XL

Last reviewed on RxList: 4/6/2017
Requip XL Side Effects Center

Last reviewed on RxList 02/15/2017

Requip XL (ropinirole extended-release tablets) is a non-ergoline dopamine agonist that works by helping restore the balance of a natural substance (dopamine) in the brain and 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). Common side effects of Requip XL include:

  • nausea,
  • vomiting,
  • drowsiness,
  • dizziness,
  • abdominal pain or discomfort,
  • stomach pain,
  • headache,
  • loss of appetite,
  • worsened RLS symptoms early in the morning,
  • diarrhea,
  • constipation,
  • dry mouth,
  • sweating,
  • sleep problems (insomnia),
  • agitation, or
  • anxiety.

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 Requip XL, when your dose is increased, or when you get up suddenly. Tell your doctor if you have serious side effects of Requip XL including:

  • new or worsening uncontrolled movements (dyskinesia),
  • mental/mood changes (such as agitation, confusion, hallucinations), or
  • unusual strong urges (such as increased gambling, increased sexual urges).

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. Breastfeeding 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.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Requip XL Consumer Information

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);
  • 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Requip XL (Ropinirole Extended Release Tablets)

Requip XL Professional Information

SIDE EFFECTS

The following adverse reactions are described in more detail in other sections of the label:

Clinical Trials 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, patients with advanced Parkinson's disease received REQUIP XL or placebo as adjunctive therapy with L-dopa in a flexible-dose clinical trial. In a flexible-dose trial, patients with early Parkinson's disease were treated with REQUIP XL or the immediate-release formulation of REQUIP without L-dopa. In addition, placebo-controlled, fixed-dose, postmarketing trials evaluated the dose response of REQUIP XL in patients with advanced Parkinson's disease taking L-dopa and in patients with early Parkinson's disease without concomitant L-dopa.

Advanced Parkinson's Disease (with L-dopa)

Study 1 was a 24-week, double-blind, placebo-controlled, flexible-dose trial in patients with advanced Parkinson's disease. In Study 1, the most commonly observed adverse reactions in patients treated with REQUIP XL (incidence at least 5% greater than placebo) were dyskinesia, nausea, dizziness, and hallucinations.

In Study 1, approximately 6% of patients treated with REQUIP XL discontinued treatment due to adverse reactions, compared with 5% of patients who received placebo. The most common adverse reaction in patients treated with REQUIP XL causing discontinuation of treatment with REQUIP XL in Study 1 was hallucination (2%).

Table 2 lists adverse reactions that occurred in at least 2% (and were numerically greater than placebo) of patients with advanced Parkinson's disease treated with REQUIP XL who participated in Study 1. In this trial, either REQUIP XL or placebo was used as an adjunct to L-dopa.

Table 2: Incidence of Adverse Reactions in a Placebo-Controlled Flexible-Dose Trial in Advanced Stage Parkinson's Disease in Patients Taking L-dopa (Study 1) (Events ≥ 2% of Patients Treated with REQUIP XL and More Common than on Placebo)a

Body System/Adverse Reaction REQUIP XL
(n = 202) %
Placebo
(n = 191) %
Ear and labyrinth disorders
  Vertigo 4 2
Gastrointestinal disorders
  Nausea 11 4
  Abdominal pain/discomfort 6 3
  Constipation 4 2
  Diarrhea 3 2
  Dry mouth 2 < 1
General disorders
  Edema peripheral 4 1
Injury, poisoning, and procedural complications
  Fallb 2 1
Musculoskeletal and connective tissue disorders
  Back pain 3 2
Nervous system disorders
  Dyskinesiab 13 3
  Dizziness 8 3
  Somnolence 7 4
Psychiatric disorders
  Hallucination 8 2
  Anxiety 2 1
Vascular disorders
  Orthostatic hypotension 5 1
  Hypertensionb 3 2
  Hypotension 2 0
a Patients may have reported multiple adverse reactions during the trial or at discontinuation; thus, patients may be included in more than one category.
b Dose-related.

Although this trial 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 and placebo) that the incidence for dyskinesia, hypertension, and fall was dose-related to REQUIP XL.

During the titration phase, the incidence of adverse reactions in descending order of percent treatment difference was dyskinesia, nausea, abdominal pain/discomfort, orthostatic hypotension, dizziness, vertigo, hypertension, peripheral edema, and dry mouth. During the maintenance phase, the most frequently observed adverse reactions were dyskinesia, nausea, dizziness, hallucination, somnolence, fall, hypertension, abnormal 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 similar in women and men.

Study 2 was an 18-week, double-blind, placebo-controlled, fixed-dose, dose-response trial in patients with advanced Parkinson's disease. In Study 2, approximately 7% of patients treated with any dose of REQUIP XL discontinued prematurely during the titration phase because of adverse reactions, compared with 4% of patients on placebo. The percentage of patients who discontinued from the study because of an adverse reaction was 4% for REQUIP XL 4 mg, 9% for REQUIP XL 8 mg, 8% for REQUIP XL 12 mg, 8% for REQUIP XL 16 mg, and 0% for REQUIP XL 24 mg [see WARNINGS AND PRECAUTIONS]. Table 3 lists adverse reactions with an incidence of at least 5% of patients in any dose group of REQUIP XL and numerically higher than on placebo in Study 2. The most common adverse reaction (incidence for REQUIP XL all doses at least 5% greater than placebo) was dyskinesia.

Table 3: Incidence of Adverse Reactions in a Placebo-Controlled Fixed-Dose Trial in Advanced Stage Parkinson's Disease in Patients Taking L-dopa (Study 2) (Events ≥ 5% of Patients Treated with any Dose of REQUIP XL and More Common than on Placebo)

Adverse Reaction Placebo
N = 74 %
REQUIP XL
4 mg
N = 25 %
8 mg
N = 76 %
12 mg
N = 75 %
16 mg
N = 75 %
24 mg
N = 25 %
All Doses
N = 276 %
Nervous system disorders
  Somnolence 5 4 5 12 11 0 8
  Dyskinesia 1 4 4 7 11 4 7
  Dizziness 3 8 4 8 5 4 6
  Sudden onset of sleep 3 8 5 4 1 0 4
Vascular disorders
  Hypertension 1 8 1 1 4 8 3
Infections and infestations
  Nasopharyngitis 1 0 3 3 0 8 2
Musculoskeletal and connective tissue disorders
  Arthralgia 0 0 3 0 3 8 2
  Psychiatric disorders Insomnia 0 0 0 1 5 0 2

Early Parkinson's Disease (without L-dopa)

Study 3 was a 36-week, flexible-dose crossover trial in patients with early Parkinson's disease who were first treated with REQUIP XL or the immediate-release formulation of REQUIP and then crossed over to treatment with the other formulation. In Study 3, the most commonly observed adverse reactions ( ≥ 5%) in patients treated with REQUIP XL were nausea (19%), somnolence (11%), abdominal pain/discomfort (7%), dizziness (6%), headache (6%), and constipation (5%).

Study 4 was an 18-week, double-blind, placebo-controlled, fixed-dose, dose-response trial in patients with early Parkinson's disease. Overall, 7% of patients treated with any dose of REQUIP XL, including 6% during the titration phase, discontinued prematurely from the study because of adverse reactions compared with 5% of patients on placebo. The percentage of patients discontinuing prematurely because of an adverse reaction was 8% for REQUIP XL 2 mg, 5% for REQUIP XL 4 mg, 8% for REQUIP XL 8 mg, 5% for REQUIP XL 12 mg, and 15% for REQUIP XL 24 mg.

Table 4 lists adverse reactions with an incidence of at least 10% of patients in any dose group of REQUIP XL and numerically higher than on placebo in Study 4. The most common adverse reactions (incidence for REQUIP XL all doses at least 5% greater than placebo) were nausea, somnolence, sudden onset of sleep, hypertension, and headache.

Table 4: Incidence of Adverse Reactions in a Double-Blind, Placebo-Controlled, Fixed-Dose, Trial in Early Stage Parkinson's Disease (Study 4) (Events ≥ 10% of Patients Treated with any Dose of REQUIP XL and Greater % than on Placebo)

Adverse Reactions Placebo
N = 40 %
REQUIP XL
2 mg
N = 13 %
4 mg
N = 41 %
8 mg
N = 40 %
12 mg
N = 39 %
24 mg
N = 13 %
All Doses
N = 146 %
Gastrointestinal disorders
  Nausea 8 8 15 33 10 15 18
  Vomiting 5 0 5 10 0 0 4
Nervous system disorders
  Somnolence 5 15 12 10 8 8 10
  Headache 3 8 10 8 5 15 8
  Dizziness 5 0 5 10 8 8 7
  Sudden onset of sleep 0 0 5 0 10 8 5
Vascular disorders
  Hypertension 0 0 5 5 3 15 5
Musculoskeletal and connective tissue disorders
  Back pain 3 0 5 3 3 15 4

Laboratory Abnormalities

In the fixed-dose trial in advanced Parkinson's disease (Study 2), 11% of patients on REQUIP XL exhibited a shift in serum creatine phosphokinase (CPK) from normal at baseline to above the normal reference range during treatment, compared with 6% of patients on placebo. There was no clear dose-response for abnormal shifts in CPK levels in patients with early or advanced stage Parkinson's disease in either fixed-dose trial.

In the fixed-dose trial in early Parkinson's disease patients (Study 4), serum CPK shifted during treatment from normal to above the normal reference range in 10% of patients on REQUIP XL and in 5% of patients on placebo.

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 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.

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%), asthenic condition (11%), viral infection (8%), leg edema (6%), vomiting (5%), and dyspepsia (5%).

Read the entire FDA prescribing information for Requip XL (Ropinirole Extended Release Tablets)

Related Resources for Requip XL

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