May 29, 2016
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Requip

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Requip




Requip Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/6/2015

Requip (ropinirole) is a non-ergoline dopamine agonist used to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control. It is also used to treat restless legs syndrome (RLS). Requip is available in generic form. Common side effects of Requip include nausea, vomiting, stomach pain, loss of appetite, worsened RLS symptoms early in the morning, diarrhea, constipation, dry mouth, sweating, headache, dizziness, drowsiness, sleep problems (insomnia), agitation, or anxiety.

The dose of Requip depends on the condition being treated and the patient's response. Requip may interact with levodopa, ciprofloxacin, fluvoxamine, metoclopramide, omeprazole, medication used to treat nausea and vomiting or mental illness, or estrogen. Tell your doctor all medications you use. During pregnancy, Requip should be used only if prescribed. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Requip may reduce breast milk production. Consult your doctor before breast-feeding. Withdrawal symptoms such as fever, muscle stiffness, and confusion may occur if you stop the medication suddenly or if you change doses.

Our Requip (ropinirole) 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.

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 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);
  • 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 (Ropinirole Hcl)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Requip FDA Prescribing Information: Side Effects
(Adverse Reactions)

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.

Parkinson's Disease

During the premarketing development of REQUIP, patients received REQUIP either without L-dopa (early Parkinson's disease trials) or as concomitant therapy with L-dopa (advanced Parkinson's disease trials). Because these two populations may have differential risks for various adverse reactions, this section will in general present adverse reaction data for these two populations separately.

Early Parkinson's Disease (without L-dopa)

In the double-blind, placebo-controlled trials in patients with early-stage Parkinson's disease, the most commonly observed adverse reactions in patients treated with REQUIP (incidence at least 5% greater than placebo) were nausea, somnolence, dizziness, syncope, asthenic condition (i.e., asthenia, fatigue, and/or malaise), viral infection, leg edema, vomiting, and dyspepsia.

Approximately 24% of patients treated with REQUIP who participated in the double-blind, placebo-controlled early Parkinson's disease (without L-dopa) trials discontinued treatment due to adverse reactions compared with 13% of patients who received placebo. The most common adverse reactions in patients treated with REQUIP (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation were nausea and dizziness.

Table 3 lists treatment-emergent adverse reactions that occurred in at least 2% of patients with early Parkinson's disease (without L-dopa) treated with REQUIP participating in the doubleblind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients. In these trials, either REQUIP or placebo was used as early therapy (i.e., without L-dopa).

Table 3: Treatment-emergent Adverse Reaction Incidence in Double-blind, Placebo-controlled Early Parkinson's Disease (without L-dopa) Trials (Events ≥ 2% of Patients Treated with REQUIP and Numerically More Frequent than the Placebo Group)a

Body System/
Adverse Reaction
REQUIP
(n = 157)
(%)
Placebo
(n = 147)
(%)
Autonomic nervous system
  Flushing 3 1
  Dry mouth 5 3
  Increased sweating 6 4
Body as a whole
  Asthenic conditionb 16 5
  Chest pain 4 2
  Dependent edema 6 3
  Leg edema 7 1
  Pain 8 4
Cardiovascular general
  Hypertension 5 3
  Hypotension 2 0
  Orthostatic symptoms 6 5
  Syncope 12 1
Central/peripheral nervous system
  Dizziness 40 22
  Hyperkinesia 2 1
  Hypesthesia 4 2
  Vertigo 2 0
Gastrointestinal
  Abdominal pain 6 3
  Anorexia 4 1
  Dyspepsia 10 5
  Flatulence 3 1
  Nausea 60 22
  Vomiting 12 7
Heart rate/rhythm
  Extrasystoles 2 1
  Atrial fibrillation 2 0
  Palpitation 3 2
  Tachycardia 2 0
Metaboli c/nutriti onal
  Increased alkaline phosphatase 3 1
Psychiatric
  Amnesia 3 1
  Impaired concentration 2 0
  Confusion 5 1
  Hallucination 5 1
  Somnolence 40 6
  Yawning 3 0
Reproductive male
  Impotence 3 1
Resistance mechanism
  Viral infection 11 3
Respiratory
  Bronchitis 3 1
  Dyspnea 3 0
  Pharyngitis 6 4
  Rhinitis 4 3
  Sinusitis 4 3
Urinary
 Urinary tract infection 5 4
Vascular extracardiac
  Peripheral ischemia 3 0
Vision
  Eye abnormality 3 1
  Abnormal vision 6 3
  Xerophthalmia 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 Asthenic condition (i.e., asthenia, fatigue, and/or malaise).

Advanced Parkinson's Disease (with L-dopa)

In the double-blind, placebo-controlled trials in patients with advanced-stage Parkinson's disease, the most commonly observed adverse reactions in patients treated with REQUIP (incidence at least 5 % greater than placebo) were dyskinesia, somnolence, nausea, dizziness, confusion, hallucinations, increased sweating, and headache.

Approximately 24% of patients who received REQUIP in the double-blind, placebo-controlled advanced Parkinson's disease (with L-dopa) trials discontinued treatment due to adverse reactions compared with 18% of patients who received placebo. The most common adverse reaction in patients treated with REQUIP (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation was dizziness.

Table 4 lists treatment-emergent adverse reactions that occurred in at least 2% of patients with advanced Parkinson's disease (with L-dopa) treated with REQUIP who participated in the double-blind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients. In these trials, either REQUIP or placebo was used as an adjunct to L-dopa.

Table 4: Treatment-emergent Adverse Reaction Incidence in Double-blind, Placebocontrolled Advanced Parkinson's Disease (with L-dopa) Trials (Events ≥ 2% of Patients Treated with REQUIP and Numerically More Frequent than the Placebo Group)a

Body System/
Adverse Reaction
REQUIP
(n = 208)
(%)
Placebo
(n = 120)
(%)
Autonomic nervous system
  Dry mouth 5 1
  Increased sweating 7 2
Body as a whole
  Increased drug level 7 3
  Pain 5 3
Cardiovascular general
  Hypotension 2 1
  Syncope 3 2
Central/peripheral nervous system
  Dizziness 26 16
  Dyskinesia 34 13
  Falls 10 7
  Headache 17 12
  Hypokinesia 5 4
  Paresis 3 0
  Paresthesia 5 3
  Tremor 6 3
Gastrointestinal
  Abdominal pain 9 8
  Constipation 6 3
  Diarrhea 5 3
  Dysphagia 2 1
  Flatulence 2 1
  Nausea 30 18
  Increased saliva 2 1
  Vomiting 7 4
Metabolic/nutriti onal
  Weight decrease 2 1
Musculoskeletal
  Arthralgia 7 5
  Arthritis 3 1
Psychiatric
  Amnesia 5 1
  Anxiety 6 3
  Confusion 9 2
  Abnormal dreaming 3 2
  Hallucination 10 4
  Nervousness 5 3
  Somnolence 20 8
Red blood cell
  Anemia 2 0
  Resistance mechanism Upper respiratory tract infection 9 8
Respiratory
  Dyspnea 3 2
Urinary
  Pyuria 2 1
  Urinary incontinence 2 1
  Urinary tract infection 6 3
Vision
  Diplopia 2 1
a Patients may have reported multiple adverse reactions during the trial or at discontinuation; thus, patients may be included in more than one category.

Restless Legs Syndrome

In the double-blind, placebo-controlled trials in patients with RLS, the most commonly observed adverse reactions in patients treated with REQUIP (incidence at least 5% greater than placebo) were nausea, vomiting, somnolence, dizziness, and asthenic condition (i.e., asthenia, fatigue, and/or malaise).

Approximately 5% of patients treated with REQUIP who participated in the double-blind, placebo-controlled trials in the treatment of RLS discontinued treatment due to adverse reactions compared with 4% of patients who received placebo. The most common adverse reaction in patients treated with REQUIP (incidence at least 2% greater than placebo) of sufficient severity to cause discontinuation was nausea.

Table 5 lists treatment-emergent adverse reactions that occurred in at least 2% of patients with RLS treated with REQUIP participating in the 12-week, double-blind, placebo-controlled trials and were numerically more common than the incidence for placebo-treated patients.

Table 5: Treatment-emergent Adverse Reaction Incidence in Double-blind, Placebocontrolled RLS Trials (Events ≥ 2% of Patients Treated with REQUIP and Numerically More Frequent than the Placebo Group)a

Body System/
Adverse Reaction
REQUIP
(n = 496)
(%)
Placebo
(n =500)
(%)
Ear and labyrinth
  Vertigo 2 1
Gastrointestinal
  Nausea 40 8
  Vomiting 11 2
  Diarrhea 5 3
  Dyspepsia 4 3
  Dry mouth 3 2
  Abdominal pain upper 3 1
General disorders and administration site conditions
  Asthenic conditionb 9 4
  Edema peripheral 2 1
Infections and infestations
  Nasopharyngitis 9 8
  Influenza 3 2
Musculoskeletal and connective tissue
  Arthralgia 4 3
  Muscle cramps 3 2
  Pain in extremity 3 2
Nervous system
  Somnolence 12 6
  Dizziness 11 5
  Paresthesia 3 1
Respiratory, thoracic, and mediastinal
  Cough 3 2
  Nasal congestion 2 1
Skin and subcutaneous tissue
  Hyperhidrosis 3 1
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 Asthenic condition (i.e., asthenia, fatigue, and/or malaise).

Read the entire FDA prescribing information for Requip (Ropinirole Hcl)

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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