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Aerius Side Effects submitted to FDA

Total Aerius reports: 11.
Aerius FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 4.
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FDA Reported Aerius Side Effects: aplasia pure red cell, erythema infectiosum, cholestasis, anaemia, dyspnoea, pregnancy, abortion spontaneous, bone marrow failure, condition aggravated, skin lesion, rash pruritic,
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Aerius Side Effects Report #5592524-9
Physician from FRANCE reported AERIUS problem on Jan 09, 2008. Female patient was diagnosed with bronchiectasis, hypotension and was treated with AERIUS. After drug was administered, patient experienced the following problems/side effects: dysphagia, fungal infection, lip oedema, paranoia. AERIUS dosage: 5 MG; PO. During the same period patient was treated with TERCIAN, RISPERDAL, CLONAZEPAM, GUTRON, ZOPICLONE. Patient was hospitalized. Patient recovered.



Aerius Side Effects Report #5694379-0
AERIUS problem was reported by a Physician from FRANCE on Mar 28, 2008. Male patient, 85 years of age, was diagnosed with pulmonary embolism, depression and was treated with AERIUS. After drug was administered, patient experienced the following problems/side effects: anaemia, international normalised ratio increased, muscle haemorrhage, subcutaneous haematoma. AERIUS dosage: 5 MG;QD;PO. During the same period patient was treated with PREVISCAN, IXEL, FORLAX, ZOLPIDEM TARTRATE, HYDROCORTISONE, LEVOTHYROXINE, NEXIUM, ALPRAZOLAM. Patient was hospitalized. Patient recovered.



Aerius Side Effects Report #5352139-4
Physician from SPAIN reported AERIUS problem on May 29, 2007. Male patient, child 9 years of age, was diagnosed with rhinitis and was treated with AERIUS. After drug was administered, patient experienced the following problems/side effects: electrocardiogram qt corrected interval prolonged. AERIUS dosage: unknown. Patient recovered.



Aerius Side Effects Report #5369726-X
AERIUS problem was reported by a Physician from FRANCE on June 15, 2007. Male patient, 73 years of age, weighting 121.3 lb, was diagnosed with benign prostatic hyperplasia, prostate cancer, phlebitis, thrombophlebitis and was treated with AERIUS. After drug was administered, patient experienced the following problems/side effects: infection, phlebitis, thrombophlebitis, vascular purpura. AERIUS dosage: unknown. During the same period patient was treated with XATRAL, LEUPROLIDE ACETATE, PREVISCAN. Patient was hospitalized. Patient died.




Aerius Side Effects Report #5318464-8
Consumer or non-health professional from UNITED STATES reported AERIUS problem on Apr 20, 2007. Female patient was diagnosed with hypersensitivity and was treated with AERIUS. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, chills, dizziness, dyspnoea, heart rate decreased, pharyngeal oedema, swollen tongue. AERIUS dosage: unknown. During the same period patient was treated with ELTROXIN. Patient recovered.



Aerius Side Effects Report #5323100-0
AERIUS problem was reported by a Physician from INDONESIA on May 01, 2007. Female patient, 25 years of age, was diagnosed with dermatitis and was treated with AERIUS. After drug was administered, patient experienced the following problems/side effects: dermatitis allergic. AERIUS dosage: 5 MG, QD; PO. Patient was hospitalized. Patient recovered.



Aerius Side Effects Report #5332846-X
Pharmacist from CANADA reported AERIUS problem on May 14, 2007. Female patient, 59 years of age, weighting 136.7 lb, was treated with AERIUS. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, therapeutic response unexpected. AERIUS dosage: 5 MG;QD;PO. During the same period patient was treated with NOVOLIN GE TORONTO, NOVOLIN GE NPH, LOSARTAN, CRESTOR, NIFEDIPINE. Patient recovered.



Aerius Side Effects Report #5336412-1
AERIUS problem was reported by a Consumer or non-health professional from CANADA on May 14, 2007. Female patient was treated with AERIUS. After drug was administered, patient experienced the following problems/side effects: arthralgia, chest discomfort, condition aggravated, dyspnoea, hypersensitivity, lip swelling, oedema mouth, wheezing. AERIUS dosage: unknown. Patient recovered.



Aerius Side Effects Report #5264304-5
Physician from HUNGARY reported AERIUS problem on Oct 02, 2006. Male patient was diagnosed with rhinitis allergic and was treated with AERIUS. After drug was administered, patient experienced the following problems/side effects: convulsion, hiccups. AERIUS dosage: unknown. During the same period patient was treated with CONVULEX. Patient recovered.




Aerius Side Effects Report #5266648-X
AERIUS problem was reported by a Physician from GERMANY on Feb 26, 2007. Female patient was diagnosed with urticaria and was treated with AERIUS. After drug was administered, patient experienced the following problems/side effects: coronary artery disease, dyspnoea. AERIUS dosage: unknown. Patient recovered.



Aerius Side Effects Report #5268757-8
Physician from GERMANY reported AERIUS problem on Feb 28, 2007. Male patient, 64 years of age, was treated with AERIUS. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation. AERIUS dosage: unknown. Patient recovered.




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, Aerius was diagnosed with bronchiectasis, hypotension and Aerius was diagnosed with pulmonary embolism, depression and