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PHOTOFRIN

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Photofrin Adverse Events Reported to the FDA Over Time

How are Photofrin adverse event reports trending over time?

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

Most Common Photofrin Adverse Events Reported to the FDA

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

Off Label Use
29 (5.05%)
Cholangitis
26 (4.53%)
Oesophageal Stenosis
16 (2.79%)
Post Procedural Complication
15 (2.61%)
Deep Vein Thrombosis
12 (2.09%)
Bronchial Obstruction
11 (1.92%)
Hypotension
9 (1.57%)
Sepsis
8 (1.39%)
Dyspnoea
7 (1.22%)
Neoplasm Recurrence
7 (1.22%)
Oesophageal Fistula
6 (1.05%)
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Pneumonia
6 (1.05%)
Blood Bilirubin Increased
5 (.87%)
Excessive Granulation Tissue
5 (.87%)
Gastrointestinal Necrosis
5 (.87%)
Pain
5 (.87%)
Photosensitivity Reaction
5 (.87%)
Pneumonia Aspiration
5 (.87%)
Respiratory Distress
5 (.87%)
Acute Respiratory Distress Syndrome
4 (.7%)
Atrial Fibrillation
4 (.7%)
Bronchopleural Fistula
4 (.7%)
Fatigue
4 (.7%)
Fluid Overload
4 (.7%)
General Physical Health Deteriorati...
4 (.7%)
Haemoglobin Decreased
4 (.7%)
Haemoptysis
4 (.7%)
Malignant Neoplasm Progression
4 (.7%)
Oesophageal Ulcer
4 (.7%)
Pancreatitis
4 (.7%)
Pericardial Effusion
4 (.7%)
Pleural Effusion
4 (.7%)
Post Procedural Haemorrhage
4 (.7%)
Procedural Complication
4 (.7%)
Pulmonary Embolism
4 (.7%)
Pulmonary Function Test Decreased
4 (.7%)
Asthenia
3 (.52%)
Bradycardia
3 (.52%)
Cardiac Arrest
3 (.52%)
Chest Pain
3 (.52%)
Death
3 (.52%)
Dysphagia
3 (.52%)
Dysphonia
3 (.52%)
Empyema
3 (.52%)
Facial Palsy
3 (.52%)
Gastrointestinal Haemorrhage
3 (.52%)
Haematemesis
3 (.52%)
Hypoxia
3 (.52%)
Idiopathic Thrombocytopenic Purpura
3 (.52%)
Lobar Pneumonia
3 (.52%)
Lower Respiratory Tract Inflammatio...
3 (.52%)
Mediastinitis
3 (.52%)
Multi-organ Failure
3 (.52%)
Odynophagia
3 (.52%)
Oesophageal Perforation
3 (.52%)
Pyrexia
3 (.52%)
Radiation Oesophagitis
3 (.52%)
Recurrent Cancer
3 (.52%)
Sunburn
3 (.52%)
Syncope
3 (.52%)
Therapeutic Response Decreased
3 (.52%)
Tracheo-oesophageal Fistula
3 (.52%)
Abdominal Distension
2 (.35%)
Aorto-oesophageal Fistula
2 (.35%)
Atrioventricular Block First Degree
2 (.35%)
Bladder Spasm
2 (.35%)
Blood Creatinine Increased
2 (.35%)
Blood Pressure Decreased
2 (.35%)
Bronchial Secretion Retention
2 (.35%)
Cardiac Tamponade
2 (.35%)
Cardio-respiratory Arrest
2 (.35%)
Cerebral Haematoma
2 (.35%)
Cerebral Haemorrhage
2 (.35%)
Chylothorax
2 (.35%)
Coagulopathy
2 (.35%)
Collapse Of Lung
2 (.35%)
Coma
2 (.35%)
Condition Aggravated
2 (.35%)
Dehydration
2 (.35%)
Depression
2 (.35%)
Dysuria
2 (.35%)
Flatulence
2 (.35%)
Haematuria
2 (.35%)
Haemorrhage
2 (.35%)
Haemothorax
2 (.35%)
Hepatic Necrosis
2 (.35%)
Hydrothorax
2 (.35%)
Infusion Related Reaction
2 (.35%)
International Normalised Ratio Incr...
2 (.35%)
Intra-abdominal Haemorrhage
2 (.35%)
Lethargy
2 (.35%)
Lung Neoplasm
2 (.35%)
Malaise
2 (.35%)
Malnutrition
2 (.35%)
Metastatic Neoplasm
2 (.35%)
Micturition Urgency
2 (.35%)
Myocardial Infarction
2 (.35%)
Necrosis
2 (.35%)
Neoplasm Progression
2 (.35%)
Oedema Mouth
2 (.35%)
Oedema Peripheral
2 (.35%)

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

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

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

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

Bile Duct Cancer
65
Barretts Oesophagus
15
Non-small Cell Lung Cancer Stage Ii...
12
Oesophageal Carcinoma
12
Non-small Cell Lung Cancer
7
Brain Neoplasm
7
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Adenocarcinoma
7
Bronchial Carcinoma
7
Photodynamic Therapy
7
Oesophageal Squamous Cell Carcinoma
7
Metastases To Pleura
6
Bladder Cancer
5
Squamous Cell Carcinoma
4
Glioma
4
Malignant Hepatobiliary Neoplasm
4
Sarcomatosis
4
Tongue Neoplasm Malignant Stage Uns...
4
Glioblastoma Multiforme
4
Dysplasia
4
Biliary Adenoma
3
Oesophageal Squamous Cell Carcinoma...
3
Lung Neoplasm Malignant
3
Metastatic Neoplasm
3
Lip And/or Oral Cavity Cancer Stage...
2
Lip And/or Oral Cavity Cancer
2
Oesophageal Carcinoma Recurrent
2
Disease Recurrence
2
Non-small Cell Lung Cancer Stage Iv
2
Non-small Cell Lung Cancer Stage Ii
2
Meningioma
2
Carcinoma
1
Malignant Peritoneal Neoplasm
1
Oropharyngeal Cancer Stage Unspecif...
1
Metastasis
1
Tracheal Cancer
1
Oesophageal Dysplasia
1
Lung Disorder
1
Biliary Neoplasm
1
Pleural Mesothelioma
1
Epiglottic Carcinoma
1
Pain
1
Cardiac Disorder
1
Periodontal Disease
1
Neuroendocrine Carcinoma Of The Ski...
1
Pharyngeal Disorder
1
Metastases To Peritoneum
1
Malignant Pleural Effusion
1
Peritoneal Mesothelioma Malignant
1
Metastatic Malignant Melanoma
1
Neoplasm Malignant
1

Drug Labels

LabelLabelerEffective
PhotofrinPinnacle Biologics, Inc.24-JUN-11

Photofrin Case Reports

What Photofrin 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 Photofrin. 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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