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DAFALGAN

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Dafalgan Adverse Events Reported to the FDA Over Time

How are Dafalgan adverse event reports trending over time?

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

Most Common Dafalgan Adverse Events Reported to the FDA

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

Pyrexia
43 (2.23%)
Renal Failure
36 (1.87%)
Vomiting
32 (1.66%)
Cytolytic Hepatitis
31 (1.61%)
Hepatocellular Injury
30 (1.55%)
Alanine Aminotransferase Increased
27 (1.4%)
Aspartate Aminotransferase Increase...
25 (1.3%)
Gamma-glutamyltransferase Increased
25 (1.3%)
Neutropenia
24 (1.24%)
Renal Failure Acute
24 (1.24%)
Diarrhoea
23 (1.19%)
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Blood Alkaline Phosphatase Increase...
21 (1.09%)
Hypotension
20 (1.04%)
Hepatitis
19 (.98%)
Leukopenia
19 (.98%)
Pruritus
19 (.98%)
Thrombocytopenia
18 (.93%)
Cholestasis
17 (.88%)
Transaminases Increased
17 (.88%)
Anaemia
16 (.83%)
Drug Exposure During Pregnancy
16 (.83%)
Tachycardia
16 (.83%)
Confusional State
15 (.78%)
Rash Maculo-papular
15 (.78%)
International Normalised Ratio Incr...
14 (.73%)
Nausea
14 (.73%)
Hyperkalaemia
13 (.67%)
Agranulocytosis
12 (.62%)
Headache
12 (.62%)
Abdominal Pain
11 (.57%)
Acute Generalised Exanthematous Pus...
11 (.57%)
Bradycardia
11 (.57%)
C-reactive Protein Increased
11 (.57%)
Infection
11 (.57%)
Chills
10 (.52%)
Dehydration
10 (.52%)
Dermatitis Bullous
10 (.52%)
Dyspnoea
10 (.52%)
Haemoglobin Decreased
10 (.52%)
Jaundice
10 (.52%)
Toxic Skin Eruption
10 (.52%)
Drug Interaction
9 (.47%)
Eosinophilia
9 (.47%)
Hypertension
9 (.47%)
Hyponatraemia
9 (.47%)
Inflammation
9 (.47%)
Leukocytosis
9 (.47%)
Abortion Induced
8 (.41%)
Bacterial Infection
8 (.41%)
Blood Creatinine Increased
8 (.41%)
Cardiac Failure
8 (.41%)
Chest Pain
8 (.41%)
General Physical Health Deteriorati...
8 (.41%)
Liver Disorder
8 (.41%)
Metabolic Acidosis
8 (.41%)
Reversible Posterior Leukoencephalo...
8 (.41%)
Somnolence
8 (.41%)
Toxic Epidermal Necrolysis
8 (.41%)
Asthenia
7 (.36%)
Atrioventricular Block Complete
7 (.36%)
Depressed Level Of Consciousness
7 (.36%)
Hepatic Enzyme Increased
7 (.36%)
Loss Of Consciousness
7 (.36%)
Oedema Peripheral
7 (.36%)
Pain
7 (.36%)
Pancreatic Enzymes Increased
7 (.36%)
Pancytopenia
7 (.36%)
Rash
7 (.36%)
Sepsis
7 (.36%)
Atrial Fibrillation
6 (.31%)
Burning Sensation
6 (.31%)
Cholestatic Liver Injury
6 (.31%)
Clostridium Difficile Colitis
6 (.31%)
Condition Aggravated
6 (.31%)
Decreased Appetite
6 (.31%)
Epilepsy
6 (.31%)
Erythema
6 (.31%)
Erythema Nodosum
6 (.31%)
Fall
6 (.31%)
Gastrointestinal Disorder
6 (.31%)
Hepatic Failure
6 (.31%)
Hyperbilirubinaemia
6 (.31%)
Iridocyclitis
6 (.31%)
Lymphadenopathy
6 (.31%)
Mouth Ulceration
6 (.31%)
Muscular Weakness
6 (.31%)
Musculoskeletal Chest Pain
6 (.31%)
Overdose
6 (.31%)
Respiratory Disorder
6 (.31%)
Suicide Attempt
6 (.31%)
Weight Decreased
6 (.31%)
Acidosis
5 (.26%)
Acute Febrile Neutrophilic Dermatos...
5 (.26%)
Ascites
5 (.26%)
Back Pain
5 (.26%)
Bacteraemia
5 (.26%)
Bladder Tamponade
5 (.26%)
Blood Bilirubin Increased
5 (.26%)
Blood Lactate Dehydrogenase Increas...
5 (.26%)
Blood Potassium Increased
5 (.26%)
Cerebral Haemorrhage Neonatal
5 (.26%)

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

What are the most common Dafalgan 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, 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 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 According to Those Reporting Adverse Events

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

Pain
281
Drug Use For Unknown Indication
250
Product Used For Unknown Indication
56
Back Pain
38
Rheumatoid Arthritis
28
Arthralgia
25
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Pyrexia
18
Prophylaxis
15
Bone Pain
14
Headache
12
Osteoarthritis
12
Crohns Disease
11
Analgesic Therapy
11
Ill-defined Disorder
10
Cancer Pain
8
Influenza Like Illness
8
Pain In Extremity
7
Abdominal Pain
6
Fibromyalgia
5
Musculoskeletal Pain
5
Arthritis
4
Hyperthermia
4
Chest Pain
4
Skin Necrosis
3
Malaise
3
Abscess
3
Erysipelas
3
Renal Colic
3
Procedural Pain
3
Migraine
3
Extravasation
3
Q Fever
3
Arthropathy
3
Influenza
3
Premedication
3
Trigeminal Neuralgia
2
Musculoskeletal Chest Pain
2
Analgesic Effect
2
Myalgia
2
Pain Prophylaxis
2
Dyslipidaemia
2
Sinusitis
2
General Anaesthesia
2
Analgesic Intervention Supportive T...
2
Postoperative Care
2
Ankylosing Spondylitis
2
Bronchitis
1
Post-traumatic Pain
1
Herpes Zoster
1
Metastases To Bone
1
Lung Disorder
1

Dafalgan Case Reports

What Dafalgan 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. 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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