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Review Phenazopyridine Safety Reports submitted to FDA

Total Phenazopyridine reports: 3.
Phenazopyridine FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Phenazopyridine Side Effects: methaemoglobinaemia, renal failure acute, urticaria, ageusia, arthralgia, dysuria, diarrhoea, pyuria, prostate examination abnormal, ocular icterus, nail discolouration.
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Phenazopyridine Side Effects Report #5523028-7
Consumer or non-health professional from UNITED STATES reported PHENAZOPYRIDINE problem on Nov 16, 2007. Female patient, 67 years of age, weighting 132.0 lb, was diagnosed with dysuria and was treated with PHENAZOPYRIDINE. After drug was administered, patient experienced the following problems/side effects: asthenia, haemolytic anaemia, hypotension, lethargy, oxygen saturation decreased. PHENAZOPYRIDINE dosage: unknown. Patient was hospitalized. Patient recovered.

Phenazopyridine Side Effects Report #5485509-4
PHENAZOPYRIDINE problem was reported by a Pharmacist from UNITED STATES on Oct 10, 2007. Female patient, weighting 211.6 lb, was diagnosed with urinary tract infection and was treated with PHENAZOPYRIDINE. After drug was administered, patient experienced the following problems/side effects: hypersensitivity, rash macular, swelling, throat tightness. PHENAZOPYRIDINE dosage: 200 MG. Patient was hospitalized. Patient recovered.

Phenazopyridine Side Effects Report #5420227-X
Consumer or non-health professional from ISRAEL reported PHENAZOPYRIDINE problem on Aug 01, 2007. Male patient, 87 years of age, was treated with PHENAZOPYRIDINE. After drug was administered, patient experienced the following problems/side effects: anaemia macrocytic, chromaturia, cyanosis central, dysuria, methaemoglobinaemia, nail discolouration, ocular icterus, prostate examination abnormal, pyuria. PHENAZOPYRIDINE dosage: 300 MG, DAILY,. Patient was hospitalized. Patient recovered.


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asthenia, haemolytic anaemia, hypotension, lethargy, oxygen saturation decreased, hypersensitivity, rash macular, swelling, throat tightness, , was diagnosed with dysuria and was diagnosed with urinary tract infection and