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Levulan Side Effects summary

Total Levulan reports: 14.
Levulan FDA safety alerts: No.
Reported deaths: 8    Reported hospitalizations: 3.
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Levulan Side Effects: cardiac disorder, non-hodgkin's lymphoma, hepatic cirrhosis, hypotension, haematemesis, pain, vomiting, transaminases increased, sudden death, nausea, gastrointestinal necrosis,
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Levulan Side Effects reported to FDA

Levulan Side Effects Report #5661130-X
Physician from UNITED KINGDOM reported LEVULAN problem on Dec 04, 2006. Male patient was diagnosed with dysplasia and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: haematemesis. LEVULAN dosage: 60 MG/KG, ONCE, ORAL. Patient was hospitalized. Patient recovered.



Levulan Side Effects Report #5661132-3
LEVULAN problem was reported by a Physician from GERMANY on Dec 04, 2006. Female patient was diagnosed with oesophageal carcinoma and was treated with LEVULAN. LEVULAN dosage: 60 MG/KG, ORAL. Patient died.



Levulan Side Effects Report #5661135-9
Physician from GERMANY reported LEVULAN problem on Dec 04, 2006. Female patient was diagnosed with neoplasm malignant and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: cardiac disorder. LEVULAN dosage: 60 MG/KG, ORAL. Patient died.



Levulan Side Effects Report #5661138-4
LEVULAN problem was reported by a Physician from GERMANY on Dec 04, 2006. Female patient was diagnosed with barrett's oesophagus and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: cardiac disorder. LEVULAN dosage: 60 MG/KG, ORAL. Patient died.




Levulan Side Effects Report #5661140-2
Physician from GERMANY reported LEVULAN problem on Dec 04, 2006. Female patient was diagnosed with neoplasm malignant and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: cardiac disorder. LEVULAN dosage: 60 MG/KG, ORAL. Patient died.



Levulan Side Effects Report #5661141-4
LEVULAN problem was reported by a Physician from GERMANY on Dec 04, 2006. Female patient was diagnosed with oesophageal carcinoma and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: hepatic cirrhosis. LEVULAN dosage: 60 MG/KG, ORAL. Patient died.



Levulan Side Effects Report #5661142-6
Physician from GERMANY reported LEVULAN problem on Dec 04, 2006. Female patient was diagnosed with oesophageal carcinoma and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: hepatic cirrhosis. LEVULAN dosage: 60 MG/KG, ORAL. Patient died.



Levulan Side Effects Report #5661143-8
LEVULAN problem was reported by a Physician from GERMANY on Dec 04, 2006. Female patient was diagnosed with oesophageal carcinoma and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: non-hodgkin's lymphoma. LEVULAN dosage: 60 MG/KG, ORAL. Patient died.



Levulan Side Effects Report #5661144-X
Consumer or non-health professional from NETHERLANDS reported LEVULAN problem on Dec 04, 2006. Female patient was diagnosed with barrett's oesophagus and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: erosive oesophagitis, haematemesis. LEVULAN dosage: 40 MG/KG, ONCE, ORAL. Patient was hospitalized. Patient recovered.




Levulan Side Effects Report #5661145-1
LEVULAN problem was reported by a Consumer or non-health professional from NETHERLANDS on Dec 04, 2006. Female patient was diagnosed with barrett's oesophagus and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: hypotension. LEVULAN dosage: 40 MG/KG, ONCE, ORAL. Patient was hospitalized. Patient recovered.



Levulan Side Effects Report #5463843-1
Health Professional from UNITED STATES reported LEVULAN problem on July 30, 2007. Female patient was diagnosed with barrett's oesophagus and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: arteriosclerosis, gastrointestinal necrosis, nausea, pain, transaminases increased, vomiting. LEVULAN dosage: 60 MG/KG. During the same period patient was treated with PROTON PUMP, OMEPRAZOLE. Patient died.



Levulan Side Effects Report #5661961-6
LEVULAN problem was reported by a Health Professional from UNITED STATES on Sept 28, 2007. Female patient, 68 years of age, was diagnosed with actinic keratosis and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: application site erythema, application site oedema, application site rash. LEVULAN dosage: unknown. Patient recovered.



Levulan Side Effects Report #5700412-X
Consumer or non-health professional from UNITED STATES reported LEVULAN problem on Mar 24, 2008. Male patient, 60 years of age, was diagnosed with actinic keratosis and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. LEVULAN dosage: unknown. During the same period patient was treated with COUMADIN, COREG, PRAVASTATIN, LISINOPRIL. Patient recovered.



Levulan Side Effects Report #5700517-3
LEVULAN problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 08, 2008. Male patient, weighting 145.0 lb, was diagnosed with actinic keratosis and was treated with LEVULAN. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident. LEVULAN dosage: unknown. Patient recovered.




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, Levulan was diagnosed with dysplasia and Levulan was diagnosed with oesophageal carcinoma and Levulan was diagnosed with neoplasm malignant and