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Review Macrodantin Safety Reports submitted to FDA

Total Macrodantin reports: 6.
Macrodantin FDA safety alerts: No.
   Reported hospitalizations: 4.
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FDA Reported Macrodantin Side Effects: hepatitis chronic active, fatigue, hepatic trauma, weight decreased, pulmonary fibrosis, dyspnoea, nausea, liver injury, pneumonia, interstitial lung disease, disease recurrence.
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Macrodantin Side Effects Report #5594562-9
Physician from AUSTRALIA reported MACRODANTIN problem on Nov 23, 2007. Female patient, 74 years of age, was diagnosed with urinary tract infection and was treated with MACRODANTIN. After drug was administered, patient experienced the following problems/side effects: alopecia, anaemia, atrial fibrillation, cardiac disorder, cold sweat, confusional state, dehydration, diarrhoea. MACRODANTIN dosage: 50 MG,2/DAY, ORAL. During the same period patient was treated with NEXIUM, PREMARIN, MODURETIC, LANOXIN. Patient was hospitalized. Patient recovered.

Macrodantin Side Effects Report #5552271-6
MACRODANTIN problem was reported by a Consumer or non-health professional from AUSTRALIA on Nov 23, 2007. Female patient, 74 years of age, was diagnosed with urinary tract infection and was treated with MACRODANTIN. After drug was administered, patient experienced the following problems/side effects: alopecia, anaemia, atrial fibrillation, cardiac disorder, chills, dehydration, faecal incontinence, feeling cold. MACRODANTIN dosage: 100 MG, ORAL. During the same period patient was treated with PREMARIN, NEXIUM. Patient was hospitalized. Patient recovered.

Macrodantin Side Effects Report #5491575-2
Physician from UNITED STATES reported MACRODANTIN problem on Oct 19, 2007. Female patient, 73 years of age, was treated with MACRODANTIN. After drug was administered, patient experienced the following problems/side effects: antinuclear antibody positive, biopsy liver abnormal, chronic hepatitis, dyspnoea, hepatic fibrosis, hepatic necrosis, hepatitis acute, hepatotoxicity. MACRODANTIN dosage: unknown. During the same period patient was treated with TOPROL, ATACAND, ALLEGRA, FLONASE, ALLOPURINOL, NEXIUM, ZOCOR, ZETIA. Patient recovered.

Macrodantin Side Effects Report #5474199-2
MACRODANTIN problem was reported by a Physician from UNITED STATES on Sept 28, 2007. Female patient, 80 years of age, was treated with MACRODANTIN. After drug was administered, patient experienced the following problems/side effects: hepatitis, liver injury. MACRODANTIN dosage: 100MG 2X A DAY. During the same period patient was treated with EXELON, CARDIA XT, DIGOXIN, NAMENDA, RISPERDAL. Patient recovered.

Macrodantin Side Effects Report #5392015-4
Pharmacist from UNITED STATES reported MACRODANTIN problem on July 17, 2007. Female patient, 27 years of age, weighting 103.0 lb, was treated with MACRODANTIN. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, pneumonia. MACRODANTIN dosage: 100MG DAILY ORAL. Patient was hospitalized. Patient recovered.

Macrodantin Side Effects Report #5392015-4
MACRODANTIN problem was reported by a Pharmacist from UNITED STATES on July 17, 2007. Female patient, 27 years of age, weighting 103.0 lb, was treated with MACRODANTIN. After drug was administered, patient experienced the following problems/side effects: interstitial lung disease, pneumonia. MACRODANTIN dosage: 100MG DAILY ORAL. Patient was hospitalized. Patient recovered.


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alopecia, anaemia, atrial fibrillation, cardiac disorder, cold sweat, confusional state, dehydration, diarrhoea, , was diagnosed with urinary tract infection and was diagnosed with urinary tract infection and