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DAFALGAN CODEINE

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Dafalgan Codeine Adverse Events Reported to the FDA Over Time

How are Dafalgan Codeine adverse event reports trending over time?

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

Most Common Dafalgan Codeine Adverse Events Reported to the FDA

What are the most common Dafalgan Codeine adverse events reported to the FDA?

Renal Failure
10 (4.98%)
Cytolytic Hepatitis
8 (3.98%)
Diarrhoea
8 (3.98%)
Renal Failure Acute
8 (3.98%)
Vomiting
7 (3.48%)
Dehydration
5 (2.49%)
General Physical Health Deteriorati...
5 (2.49%)
Pyrexia
5 (2.49%)
Blood Potassium Increased
4 (1.99%)
Decreased Appetite
4 (1.99%)
Hypotension
4 (1.99%)
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Somnolence
4 (1.99%)
Blood Creatinine Increased
3 (1.49%)
Bundle Branch Block Left
3 (1.49%)
Chills
3 (1.49%)
Gastric Ulcer Perforation
3 (1.49%)
Hepatic Encephalopathy
3 (1.49%)
Infection
3 (1.49%)
Peritonitis
3 (1.49%)
Transaminases Increased
3 (1.49%)
Agranulocytosis
2 (1%)
Alanine Aminotransferase Increased
2 (1%)
Anaemia
2 (1%)
Anuria
2 (1%)
Aortic Valve Disease
2 (1%)
Aspartate Aminotransferase Increase...
2 (1%)
Back Pain
2 (1%)
Depressed Level Of Consciousness
2 (1%)
Drug Exposure During Pregnancy
2 (1%)
Fall
2 (1%)
Hyperkalaemia
2 (1%)
Jaundice
2 (1%)
Mitral Valve Disease
2 (1%)
Pain
2 (1%)
Peritoneal Perforation
2 (1%)
Pneumoperitoneum
2 (1%)
Sepsis
2 (1%)
Tachycardia
2 (1%)
Thrombocytopenia
2 (1%)
Toxic Skin Eruption
2 (1%)
Abdominal Discomfort
1 (.5%)
Abdominal Pain
1 (.5%)
Abortion Spontaneous
1 (.5%)
Agitation
1 (.5%)
Anaphylactic Shock
1 (.5%)
Asthenia
1 (.5%)
Atrial Fibrillation
1 (.5%)
Blood Albumin Decreased
1 (.5%)
Blood Iron Decreased
1 (.5%)
C-reactive Protein Increased
1 (.5%)
Cholelithiasis
1 (.5%)
Computerised Tomogram Abnormal
1 (.5%)
Constipation
1 (.5%)
Death
1 (.5%)
Dermatitis Bullous
1 (.5%)
Diverticulum Intestinal Haemorrhagi...
1 (.5%)
Drug Abuser
1 (.5%)
Drug Dependence
1 (.5%)
Drug Interaction
1 (.5%)
Drug Rash With Eosinophilia And Sys...
1 (.5%)
Dyspnoea
1 (.5%)
Electrocardiogram P Wave Abnormal
1 (.5%)
Epilepsy
1 (.5%)
Erythema
1 (.5%)
Gastrointestinal Erosion
1 (.5%)
Gastrointestinal Necrosis
1 (.5%)
Haematoma
1 (.5%)
Haemoglobin Decreased
1 (.5%)
Hepatic Cirrhosis
1 (.5%)
Hepatic Function Abnormal
1 (.5%)
Hiatus Hernia
1 (.5%)
Hyperbilirubinaemia
1 (.5%)
Infected Skin Ulcer
1 (.5%)
Inflammation
1 (.5%)
International Normalised Ratio Incr...
1 (.5%)
Intestinal Ischaemia
1 (.5%)
Leukocytosis
1 (.5%)
Leukopenia
1 (.5%)
Loss Of Consciousness
1 (.5%)
Malaise
1 (.5%)
Mesenteric Occlusion
1 (.5%)
Metabolic Acidosis
1 (.5%)
Microlithiasis
1 (.5%)
Myoglobinaemia
1 (.5%)
Myopathy
1 (.5%)
Nausea
1 (.5%)
Necrosis
1 (.5%)
Neutropenia
1 (.5%)
Neutrophil Percentage Increased
1 (.5%)
Overdose
1 (.5%)
Pallor
1 (.5%)
Platelet Count Decreased
1 (.5%)
Platelet Count Increased
1 (.5%)
Pregnancy
1 (.5%)
Premature Baby
1 (.5%)
Psychomotor Retardation
1 (.5%)
Respiratory Tract Inflammation
1 (.5%)
Septic Shock
1 (.5%)
Skin Exfoliation
1 (.5%)
Skin Ulcer
1 (.5%)
Suicide Attempt
1 (.5%)

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

What are the most common Dafalgan Codeine adverse events reported to the FDA?

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

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

Pain
19
Drug Use For Unknown Indication
13
Crohns Disease
11
Back Pain
7
Rheumatoid Arthritis
5
Product Used For Unknown Indication
3
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Musculoskeletal Pain
3
Osteoarthritis
2
Analgesic Therapy
2
Pain Prophylaxis
1
Chest Pain
1
Fibromyalgia
1
Joint Prosthesis User
1

Dafalgan Codeine Case Reports

What Dafalgan Codeine 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 Dafalgan Codeine. 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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