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RIVOTRIL

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Rivotril Adverse Events Reported to the FDA Over Time

How are Rivotril adverse event reports trending over time?

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

Most Common Rivotril Adverse Events Reported to the FDA

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

Somnolence
255 (2.88%)
Insomnia
134 (1.51%)
Drug Ineffective
125 (1.41%)
Headache
108 (1.22%)
Drug Exposure During Pregnancy
106 (1.2%)
Overdose
98 (1.11%)
Suicide Attempt
91 (1.03%)
Confusional State
89 (1%)
Coma
87 (.98%)
Fall
81 (.91%)
Tremor
77 (.87%)
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Dizziness
76 (.86%)
Malaise
74 (.83%)
Agitation
72 (.81%)
Drug Interaction
72 (.81%)
Nausea
71 (.8%)
Medication Error
65 (.73%)
Convulsion
61 (.69%)
Pyrexia
61 (.69%)
Amnesia
60 (.68%)
Anxiety
58 (.65%)
Depression
56 (.63%)
Fatigue
54 (.61%)
Tachycardia
53 (.6%)
Vomiting
52 (.59%)
Renal Failure Acute
51 (.58%)
Syncope
51 (.58%)
Abnormal Behaviour
50 (.56%)
Dyspnoea
49 (.55%)
Ill-defined Disorder
49 (.55%)
Epilepsy
48 (.54%)
Hypertension
48 (.54%)
Nervousness
46 (.52%)
Hypotension
44 (.5%)
Loss Of Consciousness
44 (.5%)
Disorientation
43 (.49%)
Asthenia
41 (.46%)
Hyponatraemia
41 (.46%)
Rhabdomyolysis
40 (.45%)
Withdrawal Syndrome
40 (.45%)
Suicidal Ideation
39 (.44%)
Aggression
38 (.43%)
Feeling Abnormal
37 (.42%)
Myalgia
37 (.42%)
Pruritus
37 (.42%)
Weight Increased
37 (.42%)
Coordination Abnormal
36 (.41%)
Aspartate Aminotransferase Increase...
35 (.39%)
Abdominal Pain Upper
34 (.38%)
Alanine Aminotransferase Increased
34 (.38%)
Hallucination
34 (.38%)
Pregnancy
34 (.38%)
Drug Withdrawal Syndrome
33 (.37%)
Irritability
33 (.37%)
Memory Impairment
33 (.37%)
Weight Decreased
33 (.37%)
Intentional Overdose
32 (.36%)
Abdominal Pain
31 (.35%)
Condition Aggravated
31 (.35%)
Diarrhoea
31 (.35%)
Altered State Of Consciousness
30 (.34%)
Cytolytic Hepatitis
30 (.34%)
Death
30 (.34%)
Balance Disorder
29 (.33%)
Crying
28 (.32%)
Hypoaesthesia
28 (.32%)
Depressed Level Of Consciousness
27 (.3%)
Status Epilepticus
27 (.3%)
Sudden Death
27 (.3%)
Delirium
26 (.29%)
Dyskinesia
26 (.29%)
Hepatitis
26 (.29%)
Multiple Drug Overdose Intentional
26 (.29%)
Respiratory Distress
26 (.29%)
Apathy
25 (.28%)
Constipation
25 (.28%)
Drug Administration Error
25 (.28%)
Arthralgia
24 (.27%)
Blood Pressure Increased
24 (.27%)
Bradycardia
24 (.27%)
Chest Pain
24 (.27%)
Muscular Weakness
24 (.27%)
Pain
24 (.27%)
Cardio-respiratory Arrest
23 (.26%)
Gamma-glutamyltransferase Increased
23 (.26%)
Drug Dependence
22 (.25%)
Hypoglycaemia
22 (.25%)
Neutropenia
22 (.25%)
Sleep Disorder
22 (.25%)
Vertigo
22 (.25%)
Abortion Spontaneous
21 (.24%)
Blood Creatine Phosphokinase Increa...
21 (.24%)
Bradyphrenia
21 (.24%)
Chills
21 (.24%)
Head Discomfort
21 (.24%)
Hyperhidrosis
21 (.24%)
Sensory Disturbance
21 (.24%)
Anaemia
20 (.23%)
Encephalopathy
20 (.23%)
Erythema
20 (.23%)
Gait Disturbance
20 (.23%)

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This graph shows the top adverse events submitted to the FDA for Rivotril, 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 Rivotril 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 Rivotril

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

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This graph shows the top categories of adverse events submitted to the FDA for Rivotril, 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 Rivotril 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 Rivotril According to Those Reporting Adverse Events

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

Drug Use For Unknown Indication
628
Epilepsy
266
Depression
240
Anxiety
226
Insomnia
195
Product Used For Unknown Indication
139
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Sleep Disorder
100
Pain
80
Panic Disorder
53
Convulsion
46
Sedative Therapy
44
Bipolar Disorder
44
Sleep Disorder Therapy
42
Agitation
39
Neuralgia
37
Anxiety Disorder
28
Psychotic Disorder
23
Myoclonus
23
Schizophrenia
22
Prophylaxis
22
Drug Exposure During Pregnancy
21
Ill-defined Disorder
21
Parkinsons Disease
20
Sedation
19
Status Epilepticus
18
Panic Attack
18
Neuropathy Peripheral
17
Bipolar I Disorder
17
Nervousness
14
Anxiolytic Therapy
14
Trigeminal Neuralgia
14
Migraine
13
Labyrinthitis
12
Tremor
11
Restless Legs Syndrome
11
Restlessness
11
Mania
10
Fibromyalgia
10
Obsessive-compulsive Disorder
10
Mental Disorder
10
Herpes Zoster
10
Back Pain
9
Nervous System Disorder
9
Skin Ulcer
9
Partial Seizures
9
Facial Spasm
8
Stress
8
Pain In Extremity
8
Delirium
8
Muscle Relaxant Therapy
8
Tinnitus
7

Rivotril Case Reports

What Rivotril 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 Rivotril. 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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