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Requip XL (Ropinirole Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 (5.1)
  • Syncope (5.2)
  • Symptomatic hypotension, hypotension, postural/orthostatic hypotension (5.3)
  • Elevation of blood pressure and changes in heart rate (5.4)
  • Hallucination (5.5)
  • Dyskinesia (5.6)
  • Major psychotic disorders (5.7)
  • Events with dopaminergic therapy (5.8)
  • Retinal pathology (5.9)

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, patients with advanced Parkinson’s disease received REQUIP XL or placebo as adjunctive therapy in 1 clinical trial. In a second trial, patients with early Parkinson’s disease were treated with REQUIP XL 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 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 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 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 who participated in the 26-week, double-blind, placebo-controlled study. In this study, either REQUIP XL 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 and >% with Placebo)

Body System/Adverse Reaction

REQUIP XL

(n = 202)

%

Placebo

(n = 191)

%

Ear and labyrinth disorders

Vertigo

4

2

Gastrointestinal disorders

Nausea

11

4

Constipation

4

2

Abdominal pain/discomfort

6

3

Diarrhea

3

2

Dry mouth

2

<1

General disorders

Edema peripheral

4

1

Injury, poisoning, and procedural complications

Fall*

2

1

Musculoskeletal and connective tissue disorders

Back pain

3

2

Nervous system disorders

Dyskinesia*

13

3

Dizziness

8

3

Somnolence

7

4

Psychiatric disorders

Hallucination

8

2

Anxiety

2

1

Vascular disorders

Orthostatic hypotension

5

1

Hypotension

2

0

Hypertension*

3

2

*Dose-related.

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

The incidence for many adverse reactions with REQUIP XL treatment was increased relative to placebo (i.e., REQUIP XL % - 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, 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 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 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 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 compared with the immediate-release formulation of REQUIP (i.e., REQUIP XL % - 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%).



REPORTS OF SUSPECTED REQUIP XL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Requip XL. The information is not vetted and should not be considered as verified clinical evidence.

Possible Requip XL side effects / adverse reactions in 72 year old male

Reported by a consumer/non-health professional from United States on 2011-10-26

Patient: 72 year old male

Reactions: Weight Decreased, Renal Function Test Abnormal, Fibrin Degradation Products Increased, Wound, Abasia, Aphasia, Hypokinesia, Laboratory Test Abnormal, Fatigue, Liver Function Test Abnormal, Granulocytosis, Fluid Retention, Dystonia, Urinary Tract Infection, Ill-Defined Disorder, Renal Failure, Blood Amylase Increased, Arthralgia, Swelling, Dehydration, Aspartate Aminotransferase Increased, Blood Urea Decreased, Asthenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Requip XL

Other drugs received by patient: Promiseb; Nasonex; Fexofenadine; Amantadine HCL; Requip; Glucosamine; Clonazepam; Stalevo 100; Cialis; Multi-Vitamin; Calcium + Vitamin D



Possible Requip XL side effects / adverse reactions in 78 year old male

Reported by a physician from Turkey on 2011-11-07

Patient: 78 year old male

Reactions: Sexual Abuse, Sexual Activity Increased

Suspect drug(s):
Requip XL



Possible Requip XL side effects / adverse reactions in 76 year old male

Reported by a consumer/non-health professional from United States on 2011-11-22

Patient: 76 year old male

Reactions: Hallucination, Visual

Suspect drug(s):
Coreg

Requip XL
    Dosage: 8mg per day
    Administration route: Oral
    Indication: Parkinson's Disease
    Start date: 2011-05-01

Other drugs received by patient: Losartan Potassium; Klonopin; Plavix; Namenda; Sinemet CR; Vytorin; Mobic



See index of all Requip XL side effect reports >>

Drug label data at the top of this Page last updated: 2011-12-27

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