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Debrox Side Effects submitted to FDA
Total Debrox reports: 7.Debrox FDA safety alerts: No.
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FDA Reported Debrox Side Effects: deafness transitory, ear discomfort, deafness, deafness unilateral, dyspnoea, deafness neurosensory, cerumen impaction, fear, salivary hypersecretion, loss of consciousness, fall,
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Debrox Side Effects Report #5679000-X
Consumer or non-health professional from UNITED STATES reported DEBROX problem on Mar 24, 2008. Male patient, 81 years of age, was treated with DEBROX. After drug was administered, patient experienced the following problems/side effects: auricular swelling, deafness. DEBROX dosage: unknown. Patient recovered.
Debrox Side Effects Report #5581474-X
DEBROX problem was reported by a Consumer or non-health professional from UNITED STATES on Jan 03, 2008. Female patient, 42 years of age, weighting 220.0 lb, was diagnosed with cerumen removal and was treated with DEBROX. After drug was administered, patient experienced the following problems/side effects: ear discomfort, ear infection, ear pain, feeling abnormal, instillation site erythema, instillation site irritation, instillation site reaction, no therapeutic response. DEBROX dosage: unknown. Patient recovered.
Debrox Side Effects Report #5508724-X
Consumer or non-health professional from UNITED STATES reported DEBROX problem on Nov 07, 2007. Female patient, 90 years of age, was treated with DEBROX. After drug was administered, patient experienced the following problems/side effects: deafness. DEBROX dosage: unknown. Patient recovered.
Debrox Side Effects Report #5481387-8
DEBROX problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 10, 2007. Female patient, 93 years of age, was treated with DEBROX. After drug was administered, patient experienced the following problems/side effects: deafness. DEBROX dosage: unknown. Patient recovered.

Debrox Side Effects Report #5482443-0
Consumer or non-health professional from UNITED STATES reported DEBROX problem on Oct 11, 2007. Female patient, 74 years of age, was treated with DEBROX. After drug was administered, patient experienced the following problems/side effects: accidental exposure, corneal abrasion, keratitis. DEBROX dosage: unknown. Patient recovered.
Debrox Side Effects Report #5315747-2
DEBROX problem was reported by a Consumer or non-health professional from UNITED STATES on May 03, 2007. Female patient, 80 years of age, was diagnosed with cerumen removal and was treated with DEBROX. After drug was administered, patient experienced the following problems/side effects: deafness transitory, ear discomfort, hypoacusis, tinnitus. DEBROX dosage: unknown. During the same period patient was treated with TOPROL, LISINOPRIL AND HYDROCHLOROTHIAZIDE, SYNTHROID, VITAMIN D, ACTONEL. Patient recovered.
Debrox Side Effects Report #5297995-3
Physician from UNITED STATES reported DEBROX problem on Apr 12, 2007. Female patient, 86 years of age, was treated with DEBROX. After drug was administered, patient experienced the following problems/side effects: deafness, fear. DEBROX dosage: unknown. During the same period patient was treated with COUMADIN, FLUOXETINE, SULAR, ATENOLOL AND CHLORTHALIDONE. Patient recovered.
Debrox Side Effects


