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Tropicamide Safety Reports submitted to FDA

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Total Tropicamide reports: 9.
Tropicamide FDA safety alerts: No.
   Reported hospitalizations: 1.
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FDA Reported Tropicamide Side Effects: conjunctival haemorrhage, cellulitis orbital, dizziness, hypersensitivity, eye pain, vertigo, headache, confusional state, clumsiness, balance disorder, vision blurred.
Tropicamide Usage.
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Tropicamide Side Effects Report #5270155-8
Consumer or non-health professional from UNITED KINGDOM reported TROPICAMIDE problem on Feb 27, 2007. Male patient, 74 years of age, weighting 176.4 lb, was diagnosed with mydriasis, prostatism and was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: angle closure glaucoma, floppy iris syndrome. TROPICAMIDE dosage: unknown. During the same period patient was treated with TAMSULOSIN. Patient recovered.

Tropicamide Side Effects Report #5054026-8
TROPICAMIDE problem was reported by a Consumer or non-health professional from DENMARK on June 29, 2006. Female patient, 47 years of age, was diagnosed with ophthalmological examination and was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: cholinergic syndrome, dizziness, fatigue, mydriasis, paralysis, respiratory distress. TROPICAMIDE dosage: unknown. During the same period patient was treated with PYRIDOSTIGMINE BROMIDE, ATROPINE. Patient was hospitalized. Patient recovered.

Tropicamide Side Effects Report #5096486-2
Physician from UNITED KINGDOM reported TROPICAMIDE problem on Aug 17, 2006. Male patient, 46 years of age, was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: bradycardia, syncope. TROPICAMIDE dosage: unknown. Patient recovered.

Tropicamide Side Effects Report #5396978-2
TROPICAMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 11, 2006. Female patient, 65 years of age, was diagnosed with ophthalmological examination, osteoporosis, insomnia and was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: eye irritation, keratoconjunctivitis sicca, visual acuity reduced. TROPICAMIDE dosage: unknown. During the same period patient was treated with ACTONEL, VITAMIN CAP, CALCIUM CHLORIDE, ASCORBIC ACID. Patient recovered.

Tropicamide Side Effects Report #5396982-4
Physician from UNITED STATES reported TROPICAMIDE problem on Apr 05, 2007. Female patient, 63 years of age, was diagnosed with ophthalmological examination and was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: vision blurred. TROPICAMIDE dosage: unknown. During the same period patient was treated with PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP, PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP. Patient recovered.

Tropicamide Side Effects Report #5396984-8
TROPICAMIDE problem was reported by a Health Professional from UNITED STATES on May 25, 2007. Male patient, 74 years of age, was diagnosed with ophthalmological examination, open angle glaucoma and was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: balance disorder, clumsiness, confusional state, dizziness. TROPICAMIDE dosage: unknown. During the same period patient was treated with XALATAN, TIMOPTIC. Patient recovered.

Tropicamide Side Effects Report #5399324-3
Consumer or non-health professional from UNITED STATES reported TROPICAMIDE problem on Sept 29, 2006. Female patient, 41 years of age, was diagnosed with ophthalmological examination and was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: headache, vertigo. TROPICAMIDE dosage: unknown. Patient recovered.

Tropicamide Side Effects Report #5411295-X
TROPICAMIDE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on July 24, 2007. Male patient, 79 years of age, was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: cellulitis orbital, conjunctival haemorrhage. TROPICAMIDE dosage: unknown. During the same period patient was treated with PHENYLEPHRINE, COSOPT, FLUORESCEIN. Patient recovered.

Tropicamide Side Effects Report #5411302-4
Consumer or non-health professional from UNITED KINGDOM reported TROPICAMIDE problem on July 24, 2007. Female patient, 76 years of age, was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: cellulitis orbital, conjunctival haemorrhage, eye pain, hypersensitivity. TROPICAMIDE dosage: unknown. During the same period patient was treated with PHENYLEPHRINE, ASPIRIN, FLUORESCEIN. Patient recovered.


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angle closure glaucoma, floppy iris syndrome cholinergic syndrome, dizziness, fatigue, mydriasis, paralysis, respiratory distress, was diagnosed with mydriasis, prostatism and was diagnosed with ophthalmological examination and was diagnosed with ophthalmological examination, osteoporosis, insomnia and