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Review Lekadol Safety Reports submitted to FDA

Total Lekadol reports: 6.
Lekadol FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 2.
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FDA Reported Lekadol Side Effects: death, alcohol use.
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Lekadol Side Effects Report #5679750-5
Health Professional from SLOVENIA reported LEKADOL problem on Mar 10, 2008. Male patient was diagnosed with pyrexia and was treated with LEKADOL. After drug was administered, patient experienced the following problems/side effects: dyspnoea, erythema. LEKADOL dosage: unknown. Patient was hospitalized. Patient recovered.

Lekadol Side Effects Report #5379798-4
LEKADOL problem was reported by a Consumer or non-health professional from CROATIA (local name: Hrvatska) on June 26, 2007. Female patient, 39 years of age, was diagnosed with abdominal pain and was treated with LEKADOL. After drug was administered, patient experienced the following problems/side effects: alcohol use. LEKADOL dosage: unknown. Patient died on 06/21/2007.

Lekadol Side Effects Report #5383459-5
Consumer or non-health professional from CROATIA (local name: Hrvatska) reported LEKADOL problem on June 26, 2007. Female patient, 39 years of age, was diagnosed with abdominal pain and was treated with LEKADOL. LEKADOL dosage: unknown. Patient died on 06/21/2007.

Lekadol Side Effects Report #5379798-4
LEKADOL problem was reported by a Consumer or non-health professional from CROATIA (local name: Hrvatska) on June 26, 2007. Female patient, 39 years of age, was diagnosed with abdominal pain and was treated with LEKADOL. After drug was administered, patient experienced the following problems/side effects: alcohol use. LEKADOL dosage: unknown. Patient died on 06/21/2007.

Lekadol Side Effects Report #5383459-5
Consumer or non-health professional from CROATIA (local name: Hrvatska) reported LEKADOL problem on June 26, 2007. Female patient, 39 years of age, was diagnosed with abdominal pain and was treated with LEKADOL. LEKADOL dosage: unknown. Patient died on 06/21/2007.

Lekadol Side Effects Report #5706413-X
LEKADOL problem was reported by a Health Professional from SLOVENIA on Apr 01, 2008. Male patient was diagnosed with pyrexia and was treated with LEKADOL. After drug was administered, patient experienced the following problems/side effects: dyspnoea, erythema. LEKADOL dosage: unknown. Patient was hospitalized. Patient recovered.


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