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DEROXAT

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Deroxat Adverse Events Reported to the FDA Over Time

How are Deroxat adverse event reports trending over time?

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

Most Common Deroxat Adverse Events Reported to the FDA

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

Hyponatraemia
153 (2.78%)
Drug Interaction
110 (2%)
Fall
105 (1.91%)
Confusional State
99 (1.8%)
Drug Exposure During Pregnancy
95 (1.73%)
General Physical Health Deteriorati...
61 (1.11%)
Vomiting
59 (1.07%)
Somnolence
58 (1.06%)
Disorientation
55 (1%)
Tremor
55 (1%)
Anaemia
53 (.96%)
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Nausea
51 (.93%)
Malaise
50 (.91%)
Diarrhoea
48 (.87%)
Cholestasis
46 (.84%)
Agitation
45 (.82%)
Pyrexia
45 (.82%)
Dizziness
44 (.8%)
Asthenia
42 (.76%)
Abdominal Pain
39 (.71%)
Renal Failure Acute
38 (.69%)
Hypokalaemia
36 (.66%)
Dyskinesia
33 (.6%)
Overdose
33 (.6%)
Haematoma
32 (.58%)
Loss Of Consciousness
32 (.58%)
Coma
31 (.56%)
Dyspnoea
31 (.56%)
Hypotension
31 (.56%)
Dehydration
30 (.55%)
Gamma-glutamyltransferase Increased
30 (.55%)
Thrombocytopenia
29 (.53%)
Fatigue
28 (.51%)
Hypertonia
27 (.49%)
International Normalised Ratio Incr...
27 (.49%)
Renal Failure
26 (.47%)
Abnormal Behaviour
25 (.45%)
Alanine Aminotransferase Increased
24 (.44%)
Anxiety
24 (.44%)
Convulsion
24 (.44%)
Neutropenia
24 (.44%)
Weight Decreased
24 (.44%)
Epilepsy
23 (.42%)
Disturbance In Attention
22 (.4%)
Lung Disorder
22 (.4%)
Rectal Haemorrhage
22 (.4%)
Cytolytic Hepatitis
21 (.38%)
Hyperhidrosis
21 (.38%)
Suicide Attempt
21 (.38%)
Urinary Retention
21 (.38%)
Extrapyramidal Disorder
20 (.36%)
Headache
20 (.36%)
Inflammation
20 (.36%)
Interstitial Lung Disease
20 (.36%)
Myoclonus
20 (.36%)
Pruritus
20 (.36%)
Amnesia
19 (.35%)
Anorexia
19 (.35%)
Aspartate Aminotransferase Increase...
19 (.35%)
Serotonin Syndrome
19 (.35%)
Toxic Skin Eruption
19 (.35%)
Gastrointestinal Haemorrhage
18 (.33%)
Hepatitis
18 (.33%)
Pallor
18 (.33%)
Respiratory Distress
18 (.33%)
Rhabdomyolysis
18 (.33%)
Transaminases Increased
18 (.33%)
Hypertension
17 (.31%)
Intentional Overdose
17 (.31%)
Depressed Level Of Consciousness
16 (.29%)
Gait Disturbance
16 (.29%)
Hypoxia
16 (.29%)
Leukocytosis
16 (.29%)
Mydriasis
16 (.29%)
Inappropriate Antidiuretic Hormone ...
15 (.27%)
Insomnia
15 (.27%)
Tachycardia
15 (.27%)
Head Injury
14 (.25%)
Hepatocellular Injury
14 (.25%)
Oedema Peripheral
14 (.25%)
Orthostatic Hypotension
14 (.25%)
Psychomotor Retardation
14 (.25%)
Sudden Death
14 (.25%)
C-reactive Protein Increased
13 (.24%)
Dermatitis Bullous
13 (.24%)
Grand Mal Convulsion
13 (.24%)
Hallucination
13 (.24%)
Hallucination, Visual
13 (.24%)
Hypoaesthesia
13 (.24%)
Metabolic Acidosis
13 (.24%)
Prothrombin Level Decreased
13 (.24%)
Weight Increased
13 (.24%)
Blood Creatine Phosphokinase Increa...
12 (.22%)
Bradycardia
12 (.22%)
Chest Pain
12 (.22%)
Constipation
12 (.22%)
Death
12 (.22%)
Haemoglobin Decreased
12 (.22%)
Hepatitis Fulminant
12 (.22%)
Hepatomegaly
12 (.22%)
Hypochloraemia
12 (.22%)

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

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

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

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

Depression
413
Drug Use For Unknown Indication
288
Ill-defined Disorder
63
Product Used For Unknown Indication
43
Dysthymic Disorder
41
Anxiety
31
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Major Depression
19
Affective Disorder
14
Bipolar Disorder
11
Anxiety Disorder
8
Bipolar I Disorder
6
Obsessive-compulsive Disorder
5
Unevaluable Event
4
Panic Attack
4
Mental Disorder
3
Psychotic Disorder
2
Anorexia
2
Dementia Alzheimers Type
2
Agoraphobia
2
Fatigue
2
Post-traumatic Stress Disorder
2
Agitation
2
Persecutory Delusion
2
Suicide Attempt
2
Tobacco Withdrawal Symptoms
1
Generalised Anxiety Disorder
1
Osteoarthritis
1
Social Phobia
1
Panic Reaction
1
Claustrophobia
1
Personality Disorder
1
Depressive Symptom
1
Pain
1
Central Pain Syndrome
1
Anhedonia
1
Epilepsy
1
Bulimia Nervosa
1
Hypomania
1
Parkinsons Disease
1
Drug Exposure During Pregnancy
1
Delusional Disorder, Persecutory Ty...
1
Bipolar Ii Disorder
1
Phobia
1
Hepatitis C
1
Neuralgia
1
Panic Disorder
1
General Physical Health Deteriorati...
1

Deroxat Case Reports

What Deroxat 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 Deroxat. 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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