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ROTIGOTINE

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Rotigotine Adverse Events Reported to the FDA Over Time

How are Rotigotine adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Rotigotine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Rotigotine is flagged as the suspect drug causing the adverse event.

Most Common Rotigotine Adverse Events Reported to the FDA

What are the most common Rotigotine adverse events reported to the FDA?

Fall
49 (2.91%)
Delusion
22 (1.3%)
Gait Disturbance
20 (1.19%)
Loss Of Consciousness
20 (1.19%)
Tremor
20 (1.19%)
Dehydration
17 (1.01%)
Condition Aggravated
15 (.89%)
Confusional State
15 (.89%)
Hallucination
15 (.89%)
Nausea
15 (.89%)
Anxiety
14 (.83%)
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Delirium
14 (.83%)
Hyperhidrosis
14 (.83%)
Death
13 (.77%)
Pyrexia
13 (.77%)
Sudden Death
13 (.77%)
Abnormal Behaviour
12 (.71%)
Balance Disorder
12 (.71%)
Gastric Ulcer Haemorrhage
12 (.71%)
Myocardial Infarction
12 (.71%)
Somnolence
12 (.71%)
Anaemia
11 (.65%)
Dizziness
11 (.65%)
Drug Ineffective
11 (.65%)
Dysarthria
11 (.65%)
Pain In Extremity
11 (.65%)
Sleep Attacks
11 (.65%)
Dyspnoea
10 (.59%)
Insomnia
10 (.59%)
Pain
10 (.59%)
Pallor
10 (.59%)
Unresponsive To Stimuli
10 (.59%)
Application Site Erythema
9 (.53%)
Dyskinesia
9 (.53%)
Femur Fracture
9 (.53%)
Muscle Rigidity
9 (.53%)
Activities Of Daily Living Impaired
8 (.47%)
Agitation
8 (.47%)
Arthralgia
8 (.47%)
Drug Interaction
8 (.47%)
Haematoma
8 (.47%)
Haemoglobin Decreased
8 (.47%)
Malaise
8 (.47%)
Muscle Spasms
8 (.47%)
Neuroleptic Malignant Syndrome
8 (.47%)
Urinary Tract Infection
8 (.47%)
Vomiting
8 (.47%)
Application Site Pruritus
7 (.42%)
Blood Pressure Decreased
7 (.42%)
Cardiomegaly
7 (.42%)
Expired Drug Administered
7 (.42%)
Hallucination, Auditory
7 (.42%)
Hypertension
7 (.42%)
Pathological Gambling
7 (.42%)
Psychotic Disorder
7 (.42%)
Restlessness
7 (.42%)
Rhabdomyolysis
7 (.42%)
Speech Disorder
7 (.42%)
Suicidal Ideation
7 (.42%)
Syncope
7 (.42%)
Blood Glucose Increased
6 (.36%)
Blood Urea Increased
6 (.36%)
Chest Pain
6 (.36%)
Depression
6 (.36%)
General Physical Health Deteriorati...
6 (.36%)
Hallucination, Visual
6 (.36%)
Hallucinations, Mixed
6 (.36%)
Hyponatraemia
6 (.36%)
Joint Injury
6 (.36%)
Paraesthesia
6 (.36%)
Paranoia
6 (.36%)
Posture Abnormal
6 (.36%)
Pruritus
6 (.36%)
Renal Failure Acute
6 (.36%)
Renal Impairment
6 (.36%)
Road Traffic Accident
6 (.36%)
Accident
5 (.3%)
Acute Myocardial Infarction
5 (.3%)
Application Site Burn
5 (.3%)
Application Site Reaction
5 (.3%)
Aspartate Aminotransferase Increase...
5 (.3%)
Blood Creatine Phosphokinase Increa...
5 (.3%)
Blood Lactate Dehydrogenase Increas...
5 (.3%)
Bundle Branch Block Left
5 (.3%)
Cerebral Infarction
5 (.3%)
Cerebrovascular Accident
5 (.3%)
Contusion
5 (.3%)
Decreased Appetite
5 (.3%)
Dermatitis Contact
5 (.3%)
Dopamine Dysregulation Syndrome
5 (.3%)
Dysphagia
5 (.3%)
Gastritis
5 (.3%)
Haematocrit Decreased
5 (.3%)
Hip Fracture
5 (.3%)
Hypotension
5 (.3%)
Incorrect Dose Administered
5 (.3%)
Iron Deficiency Anaemia
5 (.3%)
Mitral Valve Incompetence
5 (.3%)
Mobility Decreased
5 (.3%)
Oedema Peripheral
5 (.3%)
Pyelonephritis
5 (.3%)

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This graph shows the top adverse events submitted to the FDA for Rotigotine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Rotigotine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Rotigotine

What are the most common Rotigotine adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Rotigotine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Rotigotine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Rotigotine According to Those Reporting Adverse Events

Why are people taking Rotigotine, according to those reporting adverse events to the FDA?

Parkinsons Disease
323
Restless Legs Syndrome
30
Drug Use For Unknown Indication
5
Psychotic Disorder
4
Parkinsonism
3
Tremor
2
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Balance Disorder
1
Diabetic Neuropathy
1
Depression
1
Off Label Use
1
Fibromyalgia
1
On And Off Phenomenon
1

Drug Labels

LabelLabelerEffective
NeuproUCB, Inc.11-APR-12

Rotigotine Case Reports

What Rotigotine safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Rotigotine. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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