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THERACYS

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Theracys Adverse Events Reported to the FDA Over Time

How are Theracys adverse event reports trending over time?

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

Most Common Theracys Adverse Events Reported to the FDA

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

Pyrexia
150 (8.53%)
Chills
83 (4.72%)
Bovine Tuberculosis
71 (4.04%)
Dysuria
57 (3.24%)
Haematuria
46 (2.62%)
Arthralgia
36 (2.05%)
Fatigue
35 (1.99%)
Sepsis
34 (1.93%)
Hyperhidrosis
33 (1.88%)
Pollakiuria
33 (1.88%)
Micturition Urgency
27 (1.53%)
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Nausea
23 (1.31%)
Malaise
22 (1.25%)
Weight Decreased
22 (1.25%)
Cough
20 (1.14%)
Incorrect Dose Administered
19 (1.08%)
Asthenia
17 (.97%)
Bladder Cancer Recurrent
17 (.97%)
Joint Swelling
16 (.91%)
Oedema Peripheral
16 (.91%)
Cold Sweat
15 (.85%)
Haemorrhage Urinary Tract
15 (.85%)
Headache
15 (.85%)
Night Sweats
15 (.85%)
Anaemia
14 (.8%)
Cystitis
14 (.8%)
Myalgia
14 (.8%)
Urinary Tract Infection
14 (.8%)
Vomiting
13 (.74%)
Cystitis Noninfective
12 (.68%)
Diarrhoea
12 (.68%)
Lung Neoplasm
12 (.68%)
Tremor
12 (.68%)
Bladder Pain
11 (.63%)
Body Temperature Increased
11 (.63%)
Decreased Appetite
11 (.63%)
Dyspnoea
11 (.63%)
Muscle Spasms
11 (.63%)
Abdominal Pain Lower
10 (.57%)
Anorexia
10 (.57%)
Balance Disorder
10 (.57%)
Cognitive Disorder
10 (.57%)
Dehydration
10 (.57%)
Drug Resistance
10 (.57%)
Electroencephalogram Abnormal
10 (.57%)
Faeces Discoloured
10 (.57%)
Hypersensitivity
10 (.57%)
Motor Dysfunction
10 (.57%)
Nuclear Magnetic Resonance Imaging ...
10 (.57%)
Pain
10 (.57%)
Pseudomembranous Colitis
10 (.57%)
Skin Discolouration
10 (.57%)
Inappropriate Schedule Of Drug Admi...
9 (.51%)
Pneumonia
9 (.51%)
Adverse Drug Reaction
8 (.45%)
Bacteria Stool Identified
8 (.45%)
Lethargy
8 (.45%)
Pleural Effusion
8 (.45%)
Serum Sickness
8 (.45%)
Temperature Intolerance
8 (.45%)
Thrombocytopenia
8 (.45%)
Bladder Irritation
7 (.4%)
Blood Urine Present
7 (.4%)
Abdominal Pain Upper
6 (.34%)
Cystitis Bacterial
6 (.34%)
Depression
6 (.34%)
Diverticulum
6 (.34%)
Flank Pain
6 (.34%)
Gastritis
6 (.34%)
Neutropenia
6 (.34%)
Pain In Extremity
6 (.34%)
Urethral Pain
6 (.34%)
Accidental Exposure
5 (.28%)
Erythema
5 (.28%)
Hypotension
5 (.28%)
Liver Function Test Abnormal
5 (.28%)
Lung Disorder
5 (.28%)
Neck Pain
5 (.28%)
Pelvic Pain
5 (.28%)
Renal Disorder
5 (.28%)
Renal Failure
5 (.28%)
Sluggishness
5 (.28%)
Suprapubic Pain
5 (.28%)
Balanitis
4 (.23%)
Clostridium Difficile Colitis
4 (.23%)
Confusional State
4 (.23%)
Cystitis Interstitial
4 (.23%)
Disorientation
4 (.23%)
Disseminated Tuberculosis
4 (.23%)
Fibromyalgia
4 (.23%)
Hepatic Failure
4 (.23%)
Hydronephrosis
4 (.23%)
Hypertension
4 (.23%)
Influenza Like Illness
4 (.23%)
Lymphadenopathy
4 (.23%)
Mass
4 (.23%)
Metastatic Neoplasm
4 (.23%)
Musculoskeletal Stiffness
4 (.23%)
Nocturia
4 (.23%)
Oedema
4 (.23%)
Orchitis
4 (.23%)

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

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

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

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

Bladder Cancer
211
Immunisation
10
Product Used For Unknown Indication
7
Accidental Exposure
6
Neoplasm Prophylaxis
1
Bladder Cancer Recurrent
1
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Drug Labels

LabelLabelerEffective
TheracysSanofi Pasteur Inc.10-DEC-12

Theracys Case Reports

What Theracys 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 Theracys. 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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