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Review Genteal Safety Reports submitted to FDA

Total Genteal reports: 28.
Genteal FDA safety alerts: 2005 .
   Reported hospitalizations: 5.
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FDA Reported Genteal Side Effects: eye irritation, eyelid disorder, eye pain, cellulitis, ocular hyperaemia, eye pruritus, dyspnoea, anaphylactic shock, weight decreased, stent placement, myocardial infarction.
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Genteal Side Effects Report #5650632-8
Consumer or non-health professional from BRAZIL reported GENTEAL problem on Feb 25, 2008. Female patient, 90 years of age, weighting 114.6 lb, was diagnosed with thyroid disorder and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: anorexia, cataract operation, cataract operation complication, depression, diplopia, memory impairment, vision blurred, weight decreased. GENTEAL dosage: unknown. During the same period patient was treated with PURAN T, DIAMICRON, DIATRALINA, INDAPAMIDE, CLORIDRATO DE SERTRALINA, DICOPE, EMAMA, CALTRATE. Patient was hospitalized. Patient recovered.

Genteal Side Effects Report #5661574-6
GENTEAL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 05, 2008. Female patient was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: eye infection, intraocular pressure increased. GENTEAL dosage: unknown. During the same period patient was treated with GENTEAL MODERATE LUBRICANT EYE DROPS. Patient recovered.

Genteal Side Effects Report #5669215-9
Consumer or non-health professional from UNITED STATES reported GENTEAL problem on Mar 06, 2008. Female patient, 64 years of age, was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: corneal abrasion, eye pain, ocular hyperaemia. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5585214-X
GENTEAL problem was reported by a Consumer or non-health professional from BRAZIL on Jan 03, 2008. Female patient, 63 years of age, weighting 187.4 lb, was diagnosed with dry eye, hypercholesterolaemia, hypertension and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: eyelid operation. GENTEAL dosage: unknown. During the same period patient was treated with VYTORIN, ENALAPRIL. Patient recovered.

Genteal Side Effects Report #5518970-7
Physician from BRAZIL reported GENTEAL problem on Nov 09, 2007. Male patient, 47 years of age, weighting 176.4 lb, was diagnosed with brain oedema, abdominal pain upper and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: furuncle, hypersensitivity, pruritus, vision blurred, visual disturbance. GENTEAL dosage: unknown. During the same period patient was treated with DECADRON, PANTOPRAZOLE, TEGRETOL. Patient recovered.

Genteal Side Effects Report #5474331-0
GENTEAL problem was reported by a Physician from BRAZIL on Sept 20, 2007. Male patient, 47 years of age, weighting 176.4 lb, was diagnosed with brain oedema, abdominal pain upper and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: furuncle, hypersensitivity, pruritus, vision blurred, visual disturbance. GENTEAL dosage: unknown. During the same period patient was treated with DECADRON, PANTOPRAZOLE, TEGRETOL CR. Patient recovered.

Genteal Side Effects Report #5503960-0
Consumer or non-health professional from UNITED STATES reported GENTEAL problem on Oct 30, 2007. Male patient, 52 years of age, weighting 178.0 lb, was diagnosed with hypersensitivity and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: condition aggravated, dry eye. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5378514-X
GENTEAL problem was reported by a Consumer or non-health professional from BRAZIL on June 21, 2007. Female patient, 49 years of age, was diagnosed with dry eye, hypertension and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: eye haemorrhage, eye irritation, eye pain, eye pruritus, injury, malaise, mass excision, ocular hyperaemia, plastic surgery. GENTEAL dosage: 10 ML, QID. During the same period patient was treated with CAPTOPRIL. Patient recovered.

Genteal Side Effects Report #5383748-4
Consumer or non-health professional from COLOMBIA reported GENTEAL problem on June 27, 2007. Female patient, 51 years of age, was diagnosed with conjunctival hyperaemia and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: cellulitis, conjunctival hyperaemia. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5386210-8
GENTEAL problem was reported by a Consumer or non-health professional from UNITED STATES on July 06, 2007. Female patient, 81 years of age, was diagnosed with dry eye and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: condition aggravated, eye pain, eye pruritus, fall, headache, ocular hyperaemia. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5387231-1
Consumer or non-health professional from BRAZIL reported GENTEAL problem on July 03, 2007. Female patient, 77 years of age, weighting 149.9 lb, was diagnosed with scab, hypertension and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: angioplasty, myocardial infarction, stent placement, weight decreased. GENTEAL dosage: unknown. During the same period patient was treated with ATACAND. Patient was hospitalized. Patient recovered.

Genteal Side Effects Report #5396173-7
GENTEAL problem was reported by a Consumer or non-health professional from COLOMBIA on July 16, 2007. Female patient, 51 years of age, was diagnosed with conjunctival hyperaemia and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: cellulitis. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5378514-X
Consumer or non-health professional from BRAZIL reported GENTEAL problem on June 21, 2007. Female patient, 49 years of age, was diagnosed with dry eye, hypertension and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: eye haemorrhage, eye irritation, eye pain, eye pruritus, injury, malaise, mass excision, ocular hyperaemia, plastic surgery. GENTEAL dosage: 10 ML, QID. During the same period patient was treated with CAPTOPRIL. Patient recovered.

Genteal Side Effects Report #5383748-4
GENTEAL problem was reported by a Consumer or non-health professional from COLOMBIA on June 27, 2007. Female patient, 51 years of age, was diagnosed with conjunctival hyperaemia and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: cellulitis, conjunctival hyperaemia. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5386210-8
Consumer or non-health professional from UNITED STATES reported GENTEAL problem on July 06, 2007. Female patient, 81 years of age, was diagnosed with dry eye and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: condition aggravated, eye pain, eye pruritus, fall, headache, ocular hyperaemia. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5387231-1
GENTEAL problem was reported by a Consumer or non-health professional from BRAZIL on July 03, 2007. Female patient, 77 years of age, weighting 149.9 lb, was diagnosed with scab, hypertension and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: angioplasty, myocardial infarction, stent placement, weight decreased. GENTEAL dosage: unknown. During the same period patient was treated with ATACAND. Patient was hospitalized. Patient recovered.

Genteal Side Effects Report #5396173-7
Consumer or non-health professional from COLOMBIA reported GENTEAL problem on July 16, 2007. Female patient, 51 years of age, was diagnosed with conjunctival hyperaemia and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: cellulitis. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5728355-6
GENTEAL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 25, 2008. Female patient was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: vision blurred, visual disturbance. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5731628-4
Physician from GUATEMALA reported GENTEAL problem on Apr 28, 2008. Male patient was diagnosed with dry eye and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: crepitations, extrasystoles. GENTEAL dosage: unknown. During the same period patient was treated with NPH ILETIN II, METFORMIN, LYRICA, DICLOFENAC, VASTAREL, CAPOTEN, MEDOCOR, ZOCOR. Patient recovered.

Genteal Side Effects Report #5751513-1
GENTEAL problem was reported by a Physician from UNITED STATES on May 15, 2008. Female patient was diagnosed with dry eye and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: conjunctival oedema, eye irritation, eye pain, keratoconjunctivitis sicca, ocular hyperaemia, punctate keratitis. GENTEAL dosage: unknown. During the same period patient was treated with RESTASIS. Patient recovered.

Genteal Side Effects Report #5754081-3
Physician from UNITED STATES reported GENTEAL problem on May 23, 2008. Female patient was diagnosed with dry eye, keratoconjunctivitis sicca and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: conjunctival oedema, eye irritation, eye pain, keratoconjunctivitis sicca, ocular hyperaemia, punctate keratitis. GENTEAL dosage: unknown. During the same period patient was treated with GENTEAL PM LUBRICANT EYE OINTMENT, RESTASIS. Patient recovered.

Genteal Side Effects Report #5694450-3
GENTEAL problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 25, 2008. Female patient was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: eye infection. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5697465-4
Consumer or non-health professional from BRAZIL reported GENTEAL problem on Mar 31, 2008. Female patient, 90 years of age, weighting 114.6 lb, was diagnosed with thyroid disorder and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: anorexia, cataract operation, cataract operation complication, depression, diplopia, memory impairment, vision blurred, weight decreased. GENTEAL dosage: unknown. During the same period patient was treated with PURAN T, DIAMICRON, DIATRALINA, INDAPAMIDE, CLORIDRATO DE SERTRALINA, DICOPE, EMAMA, CALTRATE. Patient was hospitalized. Patient recovered.

Genteal Side Effects Report #5699628-0
GENTEAL problem was reported by a Physician from UNITED STATES on Mar 31, 2008. Female patient, 64 years of age, was diagnosed with corneal abrasion and was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: corneal abrasion, eye pain, ocular hyperaemia. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5699726-1
Pharmacist from ISRAEL reported GENTEAL problem on Mar 31, 2008. Female patient, 40 years of age, was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: eye inflammation, eye irritation, eye pain, ocular hyperaemia. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5718999-X
GENTEAL problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 18, 2008. Female patient was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: eye infection, intraocular pressure increased. GENTEAL dosage: unknown. During the same period patient was treated with GENTEAL MODERATE LUBRICANT EYE DROPS. Patient recovered.

Genteal Side Effects Report #5304265-3
Consumer or non-health professional from UNITED STATES reported GENTEAL problem on Apr 10, 2007. Female patient was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: deafness. GENTEAL dosage: unknown. Patient recovered.

Genteal Side Effects Report #5256129-1
GENTEAL problem was reported by a Health Professional from GERMANY on Feb 21, 2007. Female patient, 52 years of age, was treated with GENTEAL. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, dyspnoea. GENTEAL dosage: unknown. Patient was hospitalized. Patient recovered.


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anorexia, cataract operation, cataract operation complication, depression, diplopia, memory impairment, vision blurred, weight decreased, , was diagnosed with thyroid disorder and was diagnosed with dry eye, hypercholesterolaemia, hypertension and