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Durotep Adverse Events Reported to the FDA Over Time

How are Durotep adverse event reports trending over time?

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

Most Common Durotep Adverse Events Reported to the FDA

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

Wrong Technique In Drug Usage Proce...
514 (8.56%)
Drug Prescribing Error
303 (5.04%)
Somnolence
232 (3.86%)
Delirium
226 (3.76%)
Nausea
187 (3.11%)
Pain
103 (1.71%)
Respiratory Depression
100 (1.66%)
Malignant Neoplasm Progression
96 (1.6%)
Depressed Level Of Consciousness
95 (1.58%)
Constipation
92 (1.53%)
Vomiting
92 (1.53%)
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Pyrexia
91 (1.51%)
Altered State Of Consciousness
89 (1.48%)
Overdose
84 (1.4%)
Inappropriate Schedule Of Drug Admi...
80 (1.33%)
Death
74 (1.23%)
Dizziness
59 (.98%)
Dyspnoea
59 (.98%)
Malaise
54 (.9%)
Pneumonia Aspiration
51 (.85%)
Respiratory Failure
49 (.82%)
Insomnia
44 (.73%)
Drug Administration Error
43 (.72%)
Restlessness
43 (.72%)
Gastric Cancer
42 (.7%)
Incorrect Dose Administered
40 (.67%)
Inadequate Analgesia
38 (.63%)
Aspartate Aminotransferase Increase...
37 (.62%)
Lung Neoplasm Malignant
35 (.58%)
Drug Ineffective
34 (.57%)
Oxygen Saturation Decreased
33 (.55%)
Product Quality Issue
33 (.55%)
Drug Administered At Inappropriate ...
32 (.53%)
Hallucination
32 (.53%)
Condition Aggravated
31 (.52%)
Blood Pressure Decreased
30 (.5%)
Drug Interaction
30 (.5%)
Treatment Noncompliance
30 (.5%)
Decreased Appetite
29 (.48%)
Renal Impairment
28 (.47%)
Convulsion
27 (.45%)
Feeling Abnormal
27 (.45%)
Myocardial Infarction
27 (.45%)
Pancreatic Carcinoma
27 (.45%)
Disease Progression
24 (.4%)
Application Site Pruritus
23 (.38%)
Aspiration
23 (.38%)
Neoplasm Malignant
23 (.38%)
Respiratory Arrest
23 (.38%)
Drug Effect Increased
22 (.37%)
Eating Disorder
22 (.37%)
Alanine Aminotransferase Increased
21 (.35%)
Coma
21 (.35%)
Confusional State
21 (.35%)
Depression
21 (.35%)
Pneumonia
21 (.35%)
Withdrawal Syndrome
21 (.35%)
Intentional Drug Misuse
20 (.33%)
Pruritus
20 (.33%)
Abdominal Distension
19 (.32%)
Anaemia
19 (.32%)
Cough
19 (.32%)
Myoclonus
19 (.32%)
Off Label Use
19 (.32%)
Abdominal Pain Upper
18 (.3%)
Dysphagia
18 (.3%)
Headache
18 (.3%)
Hepatic Failure
18 (.3%)
Blood Alkaline Phosphatase Increase...
17 (.28%)
Loss Of Consciousness
17 (.28%)
Asthenia
16 (.27%)
Hepatic Function Abnormal
16 (.27%)
Ileus
16 (.27%)
Incorrect Drug Administration Durat...
16 (.27%)
Respiratory Rate Decreased
16 (.27%)
Uterine Cancer
16 (.27%)
Abnormal Behaviour
15 (.25%)
Application Site Erythema
15 (.25%)
Application Site Pain
15 (.25%)
Dementia
15 (.25%)
Fall
15 (.25%)
Hospitalisation
15 (.25%)
Narcotic Intoxication
15 (.25%)
Parkinsonism
15 (.25%)
Sepsis
15 (.25%)
Aggression
14 (.23%)
Back Pain
14 (.23%)
Gait Disturbance
14 (.23%)
Hypoventilation
14 (.23%)
Pain In Extremity
14 (.23%)
Speech Disorder
14 (.23%)
Sudden Death
14 (.23%)
Suicide Attempt
14 (.23%)
Tremor
14 (.23%)
Anxiety
13 (.22%)
Application Site Bleeding
13 (.22%)
Discomfort
13 (.22%)
Exposure To Extreme Temperature
13 (.22%)
Irritability
13 (.22%)
Muscle Rigidity
13 (.22%)
Blood Glucose Increased
12 (.2%)

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

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

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

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

Cancer Pain
841
Drug Use For Unknown Indication
316
Product Used For Unknown Indication
204
Pain
176
Ill-defined Disorder
94
Pain Management
27
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Back Pain
25
Metastatic Renal Cell Carcinoma
20
Analgesic Therapy
15
Multiple Myeloma
14
Metastases To Bone
12
Arthralgia
12
Scleroderma
10
Hepatic Neoplasm Malignant
9
Osteoarthritis
8
Chest Pain
8
Pain In Extremity
6
Spinal Column Stenosis
6
Bone Pain
6
Neoplasm Malignant
6
Rheumatoid Arthritis
6
Abdominal Pain Lower
5
Lung Neoplasm Malignant
5
Prostate Cancer
4
Perineal Pain
4
Spinal Compression Fracture
4
Sciatica
4
Gastric Cancer
4
Intervertebral Disc Protrusion
4
Malignant Ascites
4
Metastatic Pain
3
Scoliosis
3
Osteonecrosis
3
Musculoskeletal Pain
3
Large Intestine Carcinoma
3
Abdominal Pain
2
Central Pain Syndrome
2
Small Intestine Carcinoma
2
Uterine Cancer
2
Emphysema
2
Infective Spondylitis
2
Bone Sarcoma
2
Malignant Melanoma
2
Acute Myeloid Leukaemia
2
Sleep Disorder
2
Lip And/or Oral Cavity Cancer
2
Prostate Cancer Metastatic
2
Decubitus Ulcer
2
Ovarian Cancer Recurrent
2
Adenocarcinoma
2
Small Cell Lung Cancer Stage Unspec...
2

Durotep Case Reports

What Durotep 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 Durotep. 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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