Requip
- Generic Name: ropinirole hcl
- Brand Name: Requip
Requip (Ropinirole Hcl) side effects drug center
Requip Side Effects Center
What Is Requip?
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. Requip is also used to treat restless legs syndrome (RLS). Requip is available in generic form.
What Are Side Effects of Requip?
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,
- anxiety,
- flushing,
- weakness,
- chest pain,
- leg swelling,
- high or low blood pressure,
- lightheadedness or fainting,
- muscle spasm,
- numbness,
- spinning sensation,
- abdominal pain,
- indigestion,
- gas,
- palpitations,
- fast heart rate,
- sore throat,
- urinary tract infection, or
- vision problems.
Dosage for Requip
The dose of Requip depends on the condition being treated and the patient's response.
What Drugs, Substances, or Supplements Interact with Requip?
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.
Requip During Pregnancy and Breastfeeding
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.
Additional Information
Our Requip (ropinirole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Requip Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Some people taking ropinirole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. Tell your doctor if you have any problems with daytime sleepiness or drowsiness.
You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medicine. Talk with your doctor if this occurs.
Call your doctor at once if you have:
- extreme drowsiness, falling asleep suddenly (even after feeling alert);
- worsening or no improvement in your symptoms;
- a light-headed feeling, like you might pass out;
- unusual changes in mood or behavior;
- tremors, twitching uncontrollable muscle movements; or
- hallucinations (seeing or hearing things that are not real).
Side effects such as confusion or hallucinations may be more likely in older adults.
Common side effects may include:
- drowsiness, dizziness, weakness;
- headache, confusion, hallucinations;
- increased blood pressure (severe headache, pounding in your neck or ears, nosebleed, irregular heartbeats);
- nausea, vomiting, upset stomach, constipation;
- flu symptoms (fever, chills, body aches);
- sudden muscle movements;
- increased sweating; or
- swelling in your legs or feet.
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)
Requip Professional Information
SIDE EFFECTS
The following adverse reactions are described in more detail in other sections of the label:
- Hypersensitivity [see CONTRAINDICATIONS]
- Falling Asleep during Activities of Daily Living and Somnolence [see WARNINGS AND PRECAUTIONS]
- Syncope [see WARNINGS AND PRECAUTIONS]
- Hypotension/Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
- Hallucinations/Psychotic-like Behavior [see WARNINGS AND PRECAUTIONS]
- Dyskinesia [see WARNINGS AND PRECAUTIONS]
- Impulse Control/Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
- Withdrawal-Emergent Hyperpyrexia and Confusion [see WARNINGS AND PRECAUTIONS]
- Melanoma [see WARNINGS AND PRECAUTIONS]
- Augmentation and Early-Morning Rebound in RLS [see WARNINGS AND PRECAUTIONS]
- Fibrotic Complications [see WARNINGS AND PRECAUTIONS]
- Retinal Pathology [see WARNINGS AND PRECAUTIONS]
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 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 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 |
| Metabolic/nutritional | ||
| 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, Placebo-Controlled 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/nutritional | ||
| 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, Placebo-Controlled 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)
&Copy; Requip Patient Information is supplied by Cerner Multum, Inc. and Requip Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.