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Review Xozal Safety Reports submitted to FDA

Total Xozal reports: 8.
Xozal FDA safety alerts: No.
   Reported hospitalizations: 2.
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FDA Reported Xozal Side Effects: prothrombin time prolonged, photosensitivity reaction, international normalised ratio increased.
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Xozal Side Effects Report #5612056-9
Consumer or non-health professional from GREECE reported XOZAL problem on Jan 18, 2008. Male patient, child 4 years of age, was treated with XOZAL. After drug was administered, patient experienced the following problems/side effects: accidental overdose. XOZAL dosage: unknown. Patient recovered.

Xozal Side Effects Report #5614713-7
XOZAL problem was reported by a Consumer or non-health professional from GREECE on Jan 23, 2008. Male patient, child 10 years of age, weighting 105.8 lb, was diagnosed with dermatitis and was treated with XOZAL. After drug was administered, patient experienced the following problems/side effects: incorrect dose administered. XOZAL dosage: 5 ML ONCE PO. Patient was hospitalized. Patient recovered.

Xozal Side Effects Report #5575772-3
Physician from GREECE reported XOZAL problem on Nov 16, 2007. Male patient was treated with XOZAL. After drug was administered, patient experienced the following problems/side effects: caesarean section, pregnancy, premature baby. XOZAL dosage: unknown. Patient recovered.

Xozal Side Effects Report #5528541-4
XOZAL problem was reported by a Consumer or non-health professional from GREECE on Nov 12, 2007. Male patient, child 6 years of age, was diagnosed with hypersensitivity, rhinitis and was treated with XOZAL. After drug was administered, patient experienced the following problems/side effects: arrhythmia. XOZAL dosage: unknown. Patient was hospitalized. Patient recovered.

Xozal Side Effects Report #5393075-7
Consumer or non-health professional from GREECE reported XOZAL problem on June 20, 2007. Male patient, 68 years of age, weighting 165.3 lb, was diagnosed with pruritus and was treated with XOZAL. After drug was administered, patient experienced the following problems/side effects: international normalised ratio increased, photosensitivity reaction, prothrombin time prolonged. XOZAL dosage: unknown. During the same period patient was treated with MAREVAN. Patient recovered.

Xozal Side Effects Report #5397313-6
XOZAL problem was reported by a Consumer or non-health professional from GREECE on July 05, 2007. Male patient, 68 years of age, weighting 165.3 lb, was diagnosed with pruritus and was treated with XOZAL. After drug was administered, patient experienced the following problems/side effects: international normalised ratio increased, photosensitivity reaction, prothrombin time prolonged. XOZAL dosage: unknown. During the same period patient was treated with MAREVAN. Patient recovered.

Xozal Side Effects Report #5393075-7
Consumer or non-health professional from GREECE reported XOZAL problem on June 20, 2007. Male patient, 68 years of age, weighting 165.3 lb, was diagnosed with pruritus and was treated with XOZAL. After drug was administered, patient experienced the following problems/side effects: international normalised ratio increased, photosensitivity reaction, prothrombin time prolonged. XOZAL dosage: unknown. During the same period patient was treated with MAREVAN. Patient recovered.

Xozal Side Effects Report #5397313-6
XOZAL problem was reported by a Consumer or non-health professional from GREECE on July 05, 2007. Male patient, 68 years of age, weighting 165.3 lb, was diagnosed with pruritus and was treated with XOZAL. After drug was administered, patient experienced the following problems/side effects: international normalised ratio increased, photosensitivity reaction, prothrombin time prolonged. XOZAL dosage: unknown. During the same period patient was treated with MAREVAN. Patient recovered.


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accidental overdose, incorrect dose administered, caesarean section, pregnancy, premature baby, arrhythmia, , was diagnosed with dermatitis and was diagnosed with hypersensitivity, rhinitis and was diagnosed with pruritus and