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Review Pontal Safety Reports submitted to FDA

Total Pontal reports: 2.
Pontal FDA safety alerts: No.
   Reported hospitalizations: 1.
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FDA Reported Pontal Side Effects: hypothermia, nausea, loss of consciousness.
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Pontal Side Effects Report #5447899-8
Physician from JAPAN reported PONTAL problem on Aug 31, 2007. Female patient, weighting 12.13 lb, was diagnosed with nasopharyngitis and was treated with PONTAL. After drug was administered, patient experienced the following problems/side effects: hypothermia. PONTAL dosage: unknown. During the same period patient was treated with ALIMEZINE, ANTOBRON, FENOTEROL HYDROBROMIDE, ERICANAL. Patient was hospitalized. Patient recovered.

Pontal Side Effects Report #5335371-5
PONTAL problem was reported by a Consumer or non-health professional from JAPAN on May 16, 2007. Female patient, 35 years of age, was diagnosed with dysmenorrhoea, musculoskeletal pain and was treated with PONTAL. After drug was administered, patient experienced the following problems/side effects: loss of consciousness, nausea. PONTAL dosage: unknown. Patient recovered.


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hypothermia, loss of consciousness, nausea, , was diagnosed with nasopharyngitis and was diagnosed with dysmenorrhoea, musculoskeletal pain and