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Requip (Ropinirole Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Parkinson's Disease

 During the premarketing development of REQUIP, patients received REQUIP either without L-dopa (early Parkinson's disease studies) or as concomitant therapy with L-dopa (advanced Parkinson's disease studies). Because these 2 populations may have differential risks for various adverse events, this section will, in general, present adverse event data for these 2 populations separately.

Early Parkinson's Disease (Without L-dopa)

The most commonly observed adverse events (>5%) in the double-blind, placebo-controlled early Parkinson's disease trials associated with the use of REQUIP (n = 157) not seen at an equivalent frequency among the placebo-treated patients (n = 147) were, in order of decreasing incidence: nausea, dizziness, somnolence, headache, vomiting, syncope, fatigue, dyspepsia, viral infection, constipation, pain, increased sweating, asthenia, dependent/leg edema, orthostatic symptoms, abdominal pain, pharyngitis, confusion, hallucinations, urinary tract infections, and abnormal vision.

Approximately 24% of 157 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 events compared to 13% of 147 patients who received placebo. The adverse events most commonly causing discontinuation of treatment by patients treated with REQUIP were: nausea (6.4%), dizziness (3.8%), aggravated Parkinson's disease (1.3%), hallucinations (1.3%), somnolence (1.3%), vomiting (1.3%), and headache (1.3%). Of these, hallucinations appear to be dose-related. While other adverse events leading to discontinuation may be dose-related, the titration design utilized in these trials precluded an adequate assessment of the dose response. For example, in the larger of the 2 trials described in CLINICAL PHARMACOLOGY: Clinical Trials, the difference in the rate of discontinuations emerged only after 10 weeks of treatment, suggesting, although not proving, that the effect could be related to dose.

Adverse Event Incidence in Controlled Clinical Studies

Table 2 lists treatment-emergent adverse events that occurred in ≥2% of patients with early Parkinson's disease (without L-dopa) treated with REQUIP participating in the double-blind, placebo-controlled studies and were numerically more common in the group treated with REQUIP. In these studies, either REQUIP or placebo was used as early therapy (i.e., without L-dopa).

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse-events incidence rate in the population studied.

Table 2. Treatment-Emergent Adverse Event * 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)

Adverse Experience

REQUIP

(n = 157)

(%)

Placebo

(n = 147)

(%)

Autonomic nervous system

Flushing

3

1

Dry mouth

5

3

Increased sweating

6

4

Body as a whole

Asthenia

6

1

Chest pain

4

2

Dependent edema

6

3

Leg edema

7

1

Fatigue

11

4

Malaise

3

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 system

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 system

Bronchitis

3

1

Dyspnea

3

0

Pharyngitis

6

4

Rhinitis

4

3

Sinusitis

4

3

Urinary system

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 experiences during the study or at discontinuation; thus, patients may be included in more than one category.

Other events reported by 1% or more of early Parkinson's disease (without L-dopa) patients treated with REQUIP, but that were equally or more frequent in the placebo group, were: headache, upper respiratory infection, insomnia, arthralgia, tremor, back pain, anxiety, dyskinesias, aggravated Parkinsonism, depression, falls, myalgia, leg cramps, paresthesias, nervousness, diarrhea, arthritis, hot flushes, weight loss, rash, cough, hyperglycemia, muscle spasm, arthrosis, abnormal dreams, dystonia, increased salivation, bradycardia, gout, basal cell carcinoma, gingivitis, hematuria, and rigors.

Among the treatment-emergent adverse events in patients treated with REQUIP, hallucinations appear to be dose-related.

The incidence of adverse events was not materially different between women and men.

Advanced Parkinson's Disease (With L-dopa)

The most commonly observed adverse events (>5%), in the double-blind, placebo-controlled advanced Parkinson's disease (with L-dopa) trials associated with the use of REQUIP (n = 208) as an adjunct to L-dopa not seen at an equivalent frequency among the placebo-treated patients (n = 120) were, in order of decreasing incidence: dyskinesias, nausea, dizziness, aggravated Parkinsonism, somnolence, headache, insomnia, injury, hallucinations, falls, abdominal pain, upper respiratory infection, confusion, increased sweating, vomiting, viral infection, increased drug level, arthralgia, tremor, anxiety, urinary tract infection, constipation, dry mouth, pain, hypokinesia, and paresthesia.

Approximately 24% of 208 patients who received REQUIP in the double-blind, placebo-controlled advanced Parkinson's disease (with L-dopa) trials discontinued treatment due to adverse events compared to 18% of 120 patients who received placebo. The events most commonly (≥1%) causing discontinuation of treatment by patients treated with REQUIP were: dizziness (2.9%), dyskinesias (2.4%), vomiting (2.4%), confusion (2.4%), nausea (1.9%), hallucinations (1.9%), anxiety(1.9%), and increased sweating (1.4%). Of these, hallucinations and dyskinesias appear to be dose-related.

Adverse Event Incidence in Controlled Clinical Studies

Table 3 lists treatment-emergent adverse events that occurred in ≥2% of patients with advanced Parkinson's disease (with L-dopa) treated with REQUIP who participated in the double-blind, placebo-controlled studies and were numerically more common in the group treated with REQUIP. In these studies, either REQUIP or placebo was used as an adjunct to L-dopa. Adverse events were usually mild or moderate in intensity.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse events incidence rate in the population studied.

Table 3. Treatment-Emergent Adverse Event * 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)

Adverse Experience

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 system

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 system

Arthralgia

7

5

Arthritis

3

1

Psychiatric

Amnesia

5

1

Anxiety

6

3

Confusion

9

2

Abnormal dreaming

3

2

Hallucinations

10

4

Nervousness

5

3

Somnolence

20

8

Red blood cell

Anemia

2

0

Resistance mechanism

Upper respiratory tract infection

9

8

Respiratory system

Dyspnea

3

2

Urinary system

Pyuria

2

1

Urinary incontinence

2

1

Urinary tract infection

6

3

Vision

Diplopia

2

1

* Patients may have reported multiple adverse experiences during the study or at discontinuation; thus, patients may be included in more than one category.

Other events reported by 1% or more of patients treated with both REQUIP and L-dopa, but equally or more frequent in the placebo/L-dopa group, were: myocardial infarction, orthostatic symptoms, virus infections, asthenia, dyspepsia, myalgia, back pain, depression, leg cramps, fatigue, rhinitis, chest pain, hematuria, vertigo, tinnitus, leg edema, hot flushes, abnormal gait, hyperkinesia, and pharyngitis.

Among the treatment-emergent adverse events in patients treated with REQUIP, hallucinations and dyskinesias appear to be dose-related.

Restless Legs Syndrome

 The most commonly observed adverse events (>5%) in the 12-week double-blind, placebo-controlled trials in the treatment of Restless Legs Syndrome with REQUIP (n = 496) and at least twice the rate for placebo-treated patients (n = 500) were, in order of decreasing incidence: nausea, somnolence, vomiting, dizziness, and fatigue (see Table 4). Occurrences of nausea in clinical trials were generally mild to moderate in intensity (see also DOSAGE AND ADMINISTRATION: General Dosing Considerations).

Approximately 5% of 496 patients treated with REQUIP who participated in the double-blind, placebo-controlled trials in the treatment of RLS discontinued treatment due to adverse events compared to 4% of 500 patients who received placebo. The adverse events most commonly causing discontinuation of treatment by patients treated with REQUIP were: nausea (1.6%), dizziness (0.8 %), and headache (0.8%).

Adverse Event Incidence in Controlled Clinical Studies

  Table 4 lists treatment-emergent adverse events that occurred in ≥2% of patients with RLS treated with REQUIP participating in the 12-week double-blind, placebo-controlled studies and were numerically more common in the group treated with REQUIP.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical studies. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. However, the cited figures do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse-events incidence rate in the population studied.

Table 4. Treatment-Emergent Adverse Event Incidence in Double-Blind, Placebo-Controlled RLS Trials (Events ≥2% of Patients Treated With REQUIP and Numerically More Frequent Than the Placebo Group)

Adverse Experience

REQUIP

(n = 496)

(%)

Placebo

(n = 500)

(%)

Ear and labyrinth disorders

Vertigo

2

1

Gastrointestinal disorders

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

Fatigue

8

4

Edema peripheral

2

1

Infections and infestations

Nasopharyngitis

9

8

Influenza

3

2

Musculoskeletal and connective tissue disorders

Arthralgia

4

3

Muscle cramps

3

2

Pain in extremity

3

2

Nervous system disorders

Somnolence

12

6

Dizziness

11

5

Paresthesia

3

1

Respiratory, thoracic, and mediastinal disorders

Cough

3

2

Nasal congestion

2

1

Skin and subcutaneous tissue disorders

Hyperhidrosis

3

1

Other events reported by 2% or more of patients treated with REQUIP, but equally or more frequent in the placebo group, were headache, insomnia, restless legs syndrome, upper respiratory tract infection, back pain, and sinusitis.

Other Adverse Events Observed During All Phase 2/3 Clinical Trials for Parkinson's Disease

REQUIP has been administered to 1,599 individuals in clinical trials. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using modified WHOART dictionary terminology. These categories are used in the listing below. The frequencies presented represent the proportion of the 1,599 individuals exposed to REQUIP who experienced events of the type cited on at least 1 occasion while receiving REQUIP. All reported events that occurred at least twice (or once for serious or potentially serious events), except those already listed above, trivial events, and terms too vague to be meaningful, are included without regard to determination of a causal relationship to REQUIP, except that events very unlikely to be drug-related have been deleted.

Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients and infrequent adverse events are those occurring in 1/100 to 1/1,000 patients and rare events are those occurring in fewer than 1/1,000 patients.

Body as a Whole

Infrequent: Cellulitis, peripheral edema, fever, influenza-like symptoms, enlarged abdomen, precordial chest pain, and generalized edema. Rare: Ascites.

 

Cardiovascular

Infrequent: Cardiac failure, bradycardia, tachycardia, supraventricular tachycardia, angina pectoris, bundle branch block, cardiac arrest, cardiomegaly, aneurysm, mitral insufficiency. Rare: Ventricular tachycardia.

 

Central/Peripheral Nervous System

Frequent: Neuralgia. Infrequent: Involuntary muscle contractions, hypertonia, dysphonia, abnormal coordination, extrapyramidal disorder, migraine, choreoathetosis, coma, stupor, aphasia, convulsions, hypotonia, peripheral neuropathy, paralysis. Rare: Grand mal convulsions, hemiparesis, hemiplegia.

Endocrine

Infrequent: Hypothyroidism, gynecomastia, hyperthyroidism. Rare: Goiter, SIADH.

Gastrointestinal

Infrequent: Increased hepatic enzymes, bilirubinemia, cholecystitis, cholelithiasis colitis, dysphagia, periodontitis, fecal incontinence, gastroesophageal reflux, hemorrhoids, toothache, eructation, gastritis, esophagitis, hiccups, diverticulitis, duodenal ulcer, gastric ulcer, melena, duodenitis, gastrointestinal hemorrhage, glossitis, rectal hemorrhage, pancreatitis, stomatitis and ulcerative stomatitis, tongue edema. Rare: Biliary pain, hemorrhagic gastritis, hematemesis, salivary duct obstruction.

Hematologic

Infrequent: Purpura, thrombocytopenia, hematoma, Vitamin B12 deficiency, hypochromic anemia, eosinophilia, leukocytosis, leukopenia, lymphocytosis, lymphopenia, lymphedema.

Metabolic/Nutritional

Frequent: Increased BUN. Infrequent: Hypoglycemia, increased alkaline phosphatase, increased LDH, weight increase, hyperphosphatemia, hyperuricemia, diabetes mellitus, glycosuria, hypokalemia, hypercholesterolemia, hyperkalemia, acidosis, hyponatremia, thirst, increased CPK, dehydration. Rare:  Hypochloremia.

Musculoskeletal

Infrequent: Aggravated arthritis, tendonitis, osteoporosis, bursitis, polymyalgia rheumatica, muscle weakness, skeletal pain, torticollis. Rare: Dupuytren's contracture requiring surgery.

Neoplasm

Infrequent:  Malignant breast neoplasm. Rare: Bladder carcinoma, benign brain neoplasm, esophageal carcinoma, malignant laryngeal neoplasm, lipoma, rectal carcinoma, uterine neoplasm.

Psychiatric

Infrequent: Increased libido, agitation, apathy, impaired concentration, depersonalization, paranoid reaction, personality disorder, euphoria, delirium, dementia, delusion, emotional lability, decreased libido, manic reaction, somnambulism, aggressive reaction, neurosis. Rare: Suicide attempt.

Genitourinary

Infrequent: Amenorrhea, vaginal hemorrhage, penile disorder, prostatic disorder, balanoposthitis, epididymitis, perineal pain, dysuria, micturition frequency, albuminuria, nocturia, polyuria, renal calculus. Rare: Breast enlargement, mastitis, uterine hemorrhage, ejaculation disorder, Peyronie's disease, pyelonephritis, acute renal failure, uremia.

Resistance Mechanism

Infrequent: Herpes zoster, otitis media, sepsis, abscess, herpes simplex, fungal infection, genital moniliasis.

Respiratory

Infrequent: Asthma, epistaxis, laryngitis, pleurisy, pulmonary edema.

Skin/Appendage

Infrequent : Pruritus, dermatitis, eczema, skin ulceration, alopecia, skin hypertrophy, skin discoloration, urticaria, fungal dermatitis, furunculosis, hyperkeratosis, photosensitivity reaction, psoriasis, maculopapular rash, psoriaform rash, seborrhea.

Special Senses

Infrequent: Tinnitus, earache, decreased hearing, abnormal lacrimation, conjunctivitis, blepharitis, glaucoma, abnormal accommodation, blepharospasm, eye pain, photophobia. Rare: Scotoma.

Vascular Extracardiac

Infrequent: Varicose veins, phlebitis, peripheral gangrene. Rare: Limb embolism, pulmonary embolism, gangrene, subarachnoid hemorrhage, deep thrombophlebitis, leg thrombophlebitis, thrombosis.

Falling Asleep During Activities of Daily Living

Patients treated with REQUIP have reported falling asleep while engaged in activities of daily living, including operation of a motor vehicle which sometimes resulted in accidents (see bolded WARNING).

Other Adverse Events Observed During Phase 2/3 Clinical Trials for RLS

REQUIP has been administered to 911 individuals in clinical trials. During these trials, all adverse events were recorded by the clinical investigators using terminology of their own choosing. To provide a meaningful estimate of the proportion of individuals having adverse events, similar types of events were grouped into a smaller number of standardized categories using MedDRA dictionary terminology. These categories are used in the listing below. The frequencies presented represent the proportion of the 911 individuals exposed to REQUIP who experienced events of the type cited on at least one occasion while receiving REQUIP. All reported events that occurred at least twice (or once for serious or potentially serious events), except those already listed, trivial events, and terms too vague to be meaningful, are included without regard to determination of a causal relationship to REQUIP, except that events very unlikely to be drug-related have been deleted.

Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients and infrequent adverse events are those occurring in 1/100 to 1/1,000 patients.

Blood and Lymphatic System Disorders

Infrequent: Anemia, lymphadenopathy.

Cardiac Disorders

Frequent: Palpitations. Infrequent: Acute coronary syndrome, angina pectoris, angina unstable, bradycardia, cardiac failure, cardiovascular disorder, coronary artery disease, myocardial infarction, sick sinus syndrome, tachycardia.

Congenital, Familial, and Genetic Disorders

Infrequent: Pigmented nevus.

Ear and Labyrinth Disorders

Infrequent: Ear pain, middle ear effusion, tinnitus.

Endocrine Disorders

Infrequent: Goiter, hypothyroidism.

Eye Disorders

Infrequent: Blepharitis, conjunctival hemorrhage, conjunctivitis, eye irritation, eye pain, keratoconjunctivitis sicca, vision blurred, visual acuity reduced, visual disturbance.

Gastrointestinal Disorders

Frequent: Abdominal pain, constipation, gastroesophageal reflux disease, stomach discomfort, toothache. Infrequent: Abdominal adhesions, abdominal discomfort, abdominal distension, abdominal pain lower, duodenal ulcer, dysphagia, eructation, flatulence, gastric disorder, gastric hemorrhage, gastric polyps, gastric ulcer, gastritis, gastrointestinal pain, hematemesis, hemorrhoids, hiatus hernia, intestinal obstruction, irritable bowel syndrome, loose stools, mouth ulceration, pancreatitis acute, peptic ulcer, rectal hemorrhage, reflux esophagitis.

General Disorders and Administration Site Conditions

Frequent: Asthenia, chest pain, influenza-like illness, rigors. Infrequent: Chest discomfort, feeling cold, feeling hot, hunger, lethargy, malaise, edema, pain, pyrexia.

Hepatobiliary Disorders

Infrequent: Cholecystitis, cholelithiasis, ischemic hepatitis.

Immune System Disorders

Infrequent: Hypersensitivity.

Infections and Infestations

Frequent: Bronchitis, gastroenteritis, gastroenteritis viral, lower respiratory tract infection, rhinitis, tooth abscess, urinary tract infection. Infrequent: Appendicitis, bacterial infection, bladder infection, bronchitis acute, candidiasis, cellulitis, cystitis, diarrhea infectious, diverticulitis, ear infection, folliculitis, fungal infection, gastrointestinal infection, herpes simplex, infected cyst, laryngitis, localized infection, mastitis, otitis externa, otitis media, pharyngitis, pneumonia, postoperative infection, respiratory tract infection, tonsillitis, tooth infection, vaginal candidiasis, vaginal infection , vaginal mycosis, viral infection, viral upper respiratory tract infection, wound infection.

Injury, Poisoning, and Procedural Complications

Infrequent: Concussion, lower limb fracture, post procedural hemorrhage, road traffic accident.

Investigations

Infrequent: Blood cholesterol increased, blood iron decreased, blood pressure increased, blood urine present, hemoglobin decreased, heart rate increased, protein urine present, weight decreased, weight increased.

Metabolism and Nutrition Disorders

Infrequent: Anorexia, decreased appetite, diabetes mellitus non-insulin-dependent, fluid retention, gout, hypercholesterolemia.

Musculoskeletal and Connective Tissue Disorders

Frequent: Muscle spasms, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, tendonitis. Infrequent: Arthritis, aseptic necrosis bone, bone pain, bone spur, bursitis, groin pain, intervertebral disc degeneration, intervertebral disc protrusion, joint stiffness, joint swelling, localized osteoarthritis, monoarthritis, muscle contracture, muscle tightness, muscle twitching, osteoporosis, rotator cuff syndrome, sacroiliitis, synovitis.

Neoplasms Benign, Malignant, and Unspecified

Infrequent: Anaplastic thyroid cancer, angiomyolipoma, basal cell carcinoma, breast cancer, gastric cancer, gastrointestinal stromal tumor, malignant melanoma, prostate cancer, skin papilloma, squamous cell carcinoma, uterine leiomyoma.

Nervous System Disorders

Frequent: Hypoesthesia, migraine. Infrequent: Amnesia, aphasia, ataxia, balance disorder, benign intracranial hypertension, burning sensation, carpal tunnel syndrome, disturbance in attention, dizziness postural, dysgeusia, dyskinesia, head discomfort, hyperesthesia, hypersomnia, lethargy, loss of consciousness, memory impairment, migraine with aura, migraine without aura, neuralgia, sciatica, sedation, sinus headache, sleep apnea syndrome, syncope vasovagal, tension headache, transient ischemic attack, tremor.

Psychiatric Disorders

Frequent: Anxiety, depression, irritability, sleep disorder. Infrequent: Abnormal dreams, agitation, bruxism, confusional state, depressed mood, disorientation, early morning awakening, libido decreased, loss of libido, mood swings, nervousness, nightmare, panic attack, stress symptoms, tension.

Renal and Urinary Disorders

Infrequent: Dysuria, hematuria, hypertonic bladder, micturition disorder, nephrolithiasis, nocturia, pollakiuria, proteinuria, urinary retention.

Reproductive System and Breast Disorders

Frequent: Erectile dysfunction. Infrequent: Breast cyst, dysmenorrhea, menorrhagia, pelvic peritoneal adhesions, postmenopausal hemorrhage, premenstrual syndrome, prostatitis.

Respiratory, Thoracic and Mediastinal Disorders

Frequent: Asthma, pharyngolaryngeal pain. Infrequent: Dry throat, dyspnea, epistaxis, hemoptysis, hoarseness, interstitial lung disease, nasal mucosal disorder, nasal polyps, respiratory tract congestion, rhinorrhea, sinus congestion, sneezing, wheezing, yawning.

Skin and Subcutaneous Tissue Disorders

Frequent: Night sweats, rash. Infrequent: Acne, actinic keratosis, alopecia, cold sweat, dermatitis, dermatitis allergic, dermatitis contact, eczema, exanthem, face edema, photosensitivity reaction, pruritus, psoriasis, rash pruritic, skin lesion, urticaria.

Vascular Disorders

Frequent: Hot flush, hypertension, hypotension. Infrequent: Atherosclerosis, circulatory collapse, flushing, hematoma, thrombosis, varicose vein.

Postmarketing Reports

The following adverse events (not listed above in clinical trials or other sections of the prescribing information) have been identified during postapproval use of ropinirole. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Immune Systems Disorders: Hypersensitivity reactions (including urticaria, angioedema, rash, and pruritus).

Psychiatric Disorders: Impulse control symptoms, pathological gambling, increased libido including hypersexuality.



REPORTS OF SUSPECTED REQUIP SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Requip side effects / adverse reactions in 67 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 67 year old female

Reactions: Inappropriate Schedule of Drug Administration, Impaired Driving Ability, Insomnia, Disturbance in Attention, Laceration, Fall, Sudden Onset of Sleep

Suspect drug(s):
Requip

Other drugs received by patient: Antihypertensive; Diabetes Medication; Unknown Given FOR Hypercholesterolemia



Possible Requip side effects / adverse reactions in 50 year old male

Reported by a pharmacist from France on 2011-10-04

Patient: 50 year old male weighing 80.0 kg (176.0 pounds)

Reactions: Anxiety, Paranoia, Depression, Crying, Aggression

Suspect drug(s):
Requip

Other drugs received by patient: Modopar



Possible Requip side effects / adverse reactions in 77 year old female

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-10-07

Patient: 77 year old female weighing 79.0 kg (173.8 pounds)

Reactions: Venous Thrombosis, Asthenia

Adverse event resulted in: hospitalization

Suspect drug(s):
Xeloda
    Administration route: Oral
    Indication: Colon Cancer

Calcium Carbonate
    Dosage: dose as used: unk
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2008-07-01

Lovenox
    Dosage: dose as used: unk
    Indication: Thrombosis
    Start date: 2008-12-01

Lansoprazole
    Dosage: dose as used: unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2008-12-01

Requip
    Dosage: dose as used: unk
    Administration route: Oral
    Indication: Restless Legs Syndrome
    Start date: 2008-12-18

Xeloda
    Administration route: Oral
    Start date: 2008-09-30

Levothyroxine Sodium
    Dosage: dose as used: unk
    Administration route: Oral
    Indication: Thyroidectomy
    Start date: 2007-06-22

Pantoprazole
    Dosage: dose as used: unk
    Administration route: Oral
    Indication: Prophylaxis
    Start date: 2008-07-01
    End date: 2008-12-01

Dancor
    Dosage: dose as used: unk
    Administration route: Oral
    Start date: 2008-08-01

Bisoprolol Fumarate
    Dosage: dose as used: unk
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-08-01

Other drugs received by patient: Reparil; Calcium Carbonate; Colecalciferol



See index of all Requip side effect reports >>

Drug label data at the top of this Page last updated: 2009-08-24

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