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Review Solpadeine Safety Reports submitted to FDA

Total Solpadeine reports: 2.
Solpadeine FDA safety alerts: No.
Reported deaths: 2    .
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FDA Reported Solpadeine Side Effects: intentional overdose, vomiting, somnolence, respiratory failure, pancreatitis, loss of consciousness, accidental overdose, nausea, heart rate increased, dizziness, abdominal pain.
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Solpadeine Side Effects Report #5541640-6
Consumer or non-health professional from IRELAND reported SOLPADEINE problem on Nov 30, 2007. Male patient, 29 years of age, was treated with SOLPADEINE. After drug was administered, patient experienced the following problems/side effects: cardiac arrest, respiratory failure. SOLPADEINE dosage: unknown. During the same period patient was treated with ALCOHOL. Patient died on 01/11/2007.

Solpadeine Side Effects Report #5425204-0
SOLPADEINE problem was reported by a Consumer or non-health professional from IRELAND on Aug 15, 2007. Female patient, 48 years of age, was diagnosed with back pain and was treated with SOLPADEINE. After drug was administered, patient experienced the following problems/side effects: accidental overdose, loss of consciousness, pancreatitis, respiratory failure. SOLPADEINE dosage: unknown. During the same period patient was treated with CODEINE SUL, PARACETAMOL, SEDATIVES, ALCOHOL. Patient died.


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