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Review Tropicamide Safety Reports submitted to FDA

Total Tropicamide reports: 14.
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.
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Tropicamide Side Effects Report #5648351-7
Consumer or non-health professional from UNITED KINGDOM reported TROPICAMIDE problem on Feb 20, 2008. Female patient, 66 years of age, was diagnosed with eye disorder and was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: eye pain, headache, malaise. TROPICAMIDE dosage: unknown. Patient recovered.

Tropicamide Side Effects Report #5663638-X
TROPICAMIDE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Feb 21, 2008. Female patient, 66 years of age, was diagnosed with eye disorder and was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: eye pain, headache, malaise. TROPICAMIDE dosage: unknown. Patient recovered.

Tropicamide Side Effects Report #5520720-5
Physician from UNITED STATES reported TROPICAMIDE problem on Nov 15, 2007. Male patient, 82 years of age, was diagnosed with ophthalmological examination and was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: confusional state, dysarthria. TROPICAMIDE dosage: unknown. Patient was hospitalized. Patient recovered.

Tropicamide Side Effects Report #5493856-5
TROPICAMIDE problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 05, 2007. Female patient was treated with TROPICAMIDE. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock. TROPICAMIDE dosage: unknown. During the same period patient was treated with PHENYLEPHRINE SOLUTION. Patient recovered.

Tropicamide Side Effects Report #5411295-X
Consumer or non-health professional from UNITED KINGDOM reported TROPICAMIDE problem 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
TROPICAMIDE problem was reported by a Consumer or non-health professional from UNITED KINGDOM 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.

Tropicamide Side Effects Report #5396978-2
Consumer or non-health professional from UNITED STATES reported TROPICAMIDE problem 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
TROPICAMIDE problem was reported by a Physician from UNITED STATES 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
Health Professional from UNITED STATES reported TROPICAMIDE problem 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
TROPICAMIDE problem was reported by a Consumer or non-health professional from UNITED STATES 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 #5396978-2
Consumer or non-health professional from UNITED STATES reported TROPICAMIDE problem 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
TROPICAMIDE problem was reported by a Physician from UNITED STATES 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
Health Professional from UNITED STATES reported TROPICAMIDE problem 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
TROPICAMIDE problem was reported by a Consumer or non-health professional from UNITED STATES 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.


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