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Astelin Safety Reports submitted to FDA

Total Astelin reports: 10.
Astelin FDA safety alerts: No.
   Reported hospitalizations: 3.
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Reported Astelin Side Effects: atrial fibrillation, grand mal convulsion, dizziness, dyspnoea, pregnancy, abortion spontaneous, pregnancy on oral contraceptive, swelling, sinus headache, nausea, jaw disorder.
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Astelin Side Effects Report #5254729-6
Physician from UNITED STATES reported ASTELIN problem on Aug 25, 2006. Female patient, 31 years of age, weighting 160.0 lb, was diagnosed with rhinitis allergic and was treated with ASTELIN. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, pregnancy. ASTELIN dosage: unknown. During the same period patient was treated with DESOGEN, LEVOXYL, ALLEGRA. Patient recovered.

Astelin Side Effects Report #5257054-2
ASTELIN problem was reported by a Health Professional from UNITED STATES on Mar 05, 2007. Female patient, 39 years of age, weighting 135.0 lb, was diagnosed with sinusitis, upper respiratory tract infection and was treated with ASTELIN. After drug was administered, patient experienced the following problems/side effects: abasia, coordination abnormal, dyspnoea, emotional disorder, hypoaesthesia, myelitis transverse, paraesthesia, thinking abnormal. ASTELIN dosage: unknown. Patient recovered.

Astelin Side Effects Report #5375897-1
Health Professional from UNITED STATES reported ASTELIN problem on June 27, 2007. Female patient, weighting 140.0 lb, was diagnosed with rhinitis allergic and was treated with ASTELIN. After drug was administered, patient experienced the following problems/side effects: dizziness, implantable defibrillator malfunction, somnolence. ASTELIN dosage: unknown. During the same period patient was treated with ACIPHEX, CRANBERRY, COUMADIN, ALTACE, POTASSIUM CHLORIDE, LASIX, CENTRUM SILVER. Patient recovered.

Astelin Side Effects Report #5068055-1
ASTELIN problem was reported by a Pharmacist from UNITED STATES on July 19, 2006. Male patient, 51 years of age, was diagnosed with seasonal allergy and was treated with ASTELIN. After drug was administered, patient experienced the following problems/side effects: grand mal convulsion. ASTELIN dosage: unknown. Patient recovered.

Astelin Side Effects Report #5087737-9
Physician from UNITED STATES reported ASTELIN problem on Aug 07, 2006. Male patient, 51 years of age, weighting 184.0 lb, was diagnosed with seasonal allergy and was treated with ASTELIN. After drug was administered, patient experienced the following problems/side effects: grand mal convulsion. ASTELIN dosage: unknown. During the same period patient was treated with XANAX, SINGULAIR, LEVOTHROID, ALBUTEROL. Patient recovered.

Astelin Side Effects Report #5125200-7
ASTELIN problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 10, 2006. Female patient, weighting 130.0 lb, was treated with ASTELIN. After drug was administered, patient experienced the following problems/side effects: crying, dry mouth, dyspnoea, eye infection, incorrect dose administered, moaning, nasal discomfort, respiratory arrest. ASTELIN dosage: unknown. Patient recovered.

Astelin Side Effects Report #5146485-7
Physician from UNITED STATES reported ASTELIN problem on Oct 22, 2006. Female patient, 35 years of age, was diagnosed with ill-defined disorder and was treated with ASTELIN. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, palpitations. ASTELIN dosage: unknown. Patient was hospitalized. Patient recovered.

Astelin Side Effects Report #5162238-8
ASTELIN problem was reported by a Physician from UNITED STATES on Nov 06, 2006. Female patient, 35 years of age, was diagnosed with rhinitis and was treated with ASTELIN. After drug was administered, patient experienced the following problems/side effects: atrial fibrillation, atrial flutter, dizziness, mitral valve incompetence, mitral valve prolapse, sinus bradycardia, syncope. ASTELIN dosage: unknown. During the same period patient was treated with METOPROLOL TARTRATE, NASACORT, AMBIEN, BIRTH CONTROL S, SONATA. Patient was hospitalized. Patient recovered.

Astelin Side Effects Report #5426023-1
Health Professional from UNITED STATES reported ASTELIN problem on Aug 24, 2007. Female patient, weighting 140.0 lb, was diagnosed with chronic sinusitis, hypersensitivity and was treated with ASTELIN. After drug was administered, patient experienced the following problems/side effects: arthralgia, convulsion, gingival pain, insomnia, jaw disorder, nausea, sinus headache, swelling. ASTELIN dosage: unknown. During the same period patient was treated with SYNTHROID, VASAFEM, ALBUTEROL, ATROVENT, NASONEX, ROXICET. Patient recovered.

Astelin Side Effects Report #5468685-9
ASTELIN problem was reported by a Health Professional from FRANCE on Sept 10, 2007. Female patient, 31 years of age, was diagnosed with rhinitis allergic, vasomotor rhinitis, contraception and was treated with ASTELIN. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, pregnancy, pregnancy on oral contraceptive. ASTELIN dosage: unknown. During the same period patient was treated with LEVONORGESTREL AND ETHINYL ESTRADIOL. Patient was hospitalized. Patient recovered.


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abortion spontaneous, pregnancy abasia, coordination abnormal, dyspnoea, emotional disorder, hypoaesthesia, myelitis transverse, paraesthesia, thinking abnormal, was diagnosed with rhinitis allergic and was diagnosed with sinusitis, upper respiratory tract infection and