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REQUIP SIDE EFFECTS

  • Generic Name: ropinirole hcl
  • Brand Name: Requip
Last updated on MDtodate: 10/10/2022

SIDE EFFECTS

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

  • Hypersensitivity
  • Falling Asleep during Activities of Daily Living and Somnolence
  • Syncope
  • Hypotension/Orthostatic Hypotension
  • Hallucinations/Psychotic-like Behavior
  • Dyskinesia
  • Impulse Control/Compulsive Behaviors
  • Withdrawal-Emergent Hyperpyrexia and Confusion
  • Melanoma
  • Augmentation and Early-Morning Rebound in RLS
  • Fibrotic Complications
  • Retinal Pathology

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 1 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 1: 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
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 2 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 2: 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
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 3 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 3: 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
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).

 

SRC: NLM .

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