February 13, 2016
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Requip




Side Effects
Interactions

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 Requip (ropinirole hcl) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

CYP1A2 Inhibitors And Inducers

In vitro metabolism studies showed that CYP1A2 is the major enzyme responsible for the metabolism of ropinirole. There is thus the potential for inducers or inhibitors of this enzyme to alter the clearance of ropinirole. Therefore, if therapy with a drug known to be a potent inducer or inhibitor of CYP1A2 is stopped or started during treatment with REQUIP, adjustment of the dose of REQUIP may be required. Coadministration of ciprofloxacin, an inhibitor of CYP1A2, increases the AUC and Cmax of ropinirole [see CLINICAL PHARMACOLOGY]. Cigarette smoking is expected to increase the clearance of ropinirole since CYP1A2 is known to be induced by smoking [see CLINICAL PHARMACOLOGY].

Estrogens

Population pharmacokinetic analysis revealed that higher doses of estrogens (usually associated with hormone replacement therapy [HRT]) reduced the clearance of ropinirole. Starting or stopping HRT may require adjustment of dosage of REQUIP [see CLINICAL PHARMACOLOGY].

Dopamine Antagonists

Because ropinirole is a dopamine agonist, it is possible that dopamine antagonists such as neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes) or metoclopramide may reduce the efficacy of REQUIP.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/8/2016

Side Effects
Interactions

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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