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Review Nicabate Safety Reports submitted to FDA

Total Nicabate reports: 12.
Nicabate FDA safety alerts: No.
   Reported hospitalizations: 4.
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FDA Reported Nicabate Side Effects: vomiting, flatulence, faeces discoloured, dizziness, diarrhoea, abnormal faeces, headache, dependence, vision blurred, overdose, syncope.
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Nicabate Side Effects Report #5518224-9
Consumer or non-health professional from AUSTRALIA reported NICABATE problem on Nov 07, 2007. Male patient, 41 years of age, was treated with NICABATE. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, application site rash, impaired driving ability, throat tightness, tremor. NICABATE dosage: unknown. During the same period patient was treated with CITALOPRAM HYDROBROMIDE. Patient recovered.

Nicabate Side Effects Report #5409821-X
NICABATE problem was reported by a Consumer or non-health professional from AUSTRALIA on Aug 02, 2007. Male patient was treated with NICABATE. After drug was administered, patient experienced the following problems/side effects: dependence. NICABATE dosage: 4MG TWENTY TIMES PER DAY. Patient recovered.

Nicabate Side Effects Report #5376192-7
Consumer or non-health professional from AUSTRALIA reported NICABATE problem on June 26, 2007. Male patient was treated with NICABATE. After drug was administered, patient experienced the following problems/side effects: dependence. NICABATE dosage: 2MG FIFTEEN TIMES PER DAY. Patient recovered.

Nicabate Side Effects Report #5392355-9
NICABATE problem was reported by a Consumer or non-health professional from AUSTRALIA on July 12, 2007. Female patient, 49 years of age, was treated with NICABATE. After drug was administered, patient experienced the following problems/side effects: headache, overdose, vision blurred, vomiting. NICABATE dosage: unknown. Patient was hospitalized. Patient recovered.

Nicabate Side Effects Report #5399436-4
Consumer or non-health professional from AUSTRALIA reported NICABATE problem on July 19, 2007. Female patient, 49 years of age, was diagnosed with nerve injury, ill-defined disorder and was treated with NICABATE. After drug was administered, patient experienced the following problems/side effects: headache, insomnia, malaise, overdose, vision blurred, vomiting. NICABATE dosage: 21MG SINGLE DOSE. During the same period patient was treated with TEGRETOL, RABEPRAZOLE. Patient was hospitalized. Patient recovered.

Nicabate Side Effects Report #5376192-7
NICABATE problem was reported by a Consumer or non-health professional from AUSTRALIA on June 26, 2007. Male patient was treated with NICABATE. After drug was administered, patient experienced the following problems/side effects: dependence. NICABATE dosage: 2MG FIFTEEN TIMES PER DAY. Patient recovered.

Nicabate Side Effects Report #5392355-9
Consumer or non-health professional from AUSTRALIA reported NICABATE problem on July 12, 2007. Female patient, 49 years of age, was treated with NICABATE. After drug was administered, patient experienced the following problems/side effects: headache, overdose, vision blurred, vomiting. NICABATE dosage: unknown. Patient was hospitalized. Patient recovered.

Nicabate Side Effects Report #5399436-4
NICABATE problem was reported by a Consumer or non-health professional from AUSTRALIA on July 19, 2007. Female patient, 49 years of age, was diagnosed with nerve injury, ill-defined disorder and was treated with NICABATE. After drug was administered, patient experienced the following problems/side effects: headache, insomnia, malaise, overdose, vision blurred, vomiting. NICABATE dosage: 21MG SINGLE DOSE. During the same period patient was treated with TEGRETOL, RABEPRAZOLE. Patient was hospitalized. Patient recovered.

Nicabate Side Effects Report #5756922-2
Consumer or non-health professional from AUSTRALIA reported NICABATE problem on May 29, 2008. Female patient, 67 years of age, was treated with NICABATE. After drug was administered, patient experienced the following problems/side effects: aggression, depression, irritability. NICABATE dosage: unknown. Patient recovered.

Nicabate Side Effects Report #5756923-4
NICABATE problem was reported by a Consumer or non-health professional from AUSTRALIA on May 29, 2008. Female patient, 44 years of age, was treated with NICABATE. After drug was administered, patient experienced the following problems/side effects: application site pruritus, application site rash, psoriasis. NICABATE dosage: unknown. Patient recovered.

Nicabate Side Effects Report #5719535-4
Consumer or non-health professional from AUSTRALIA reported NICABATE problem on Apr 24, 2008. Female patient, 44 years of age, was treated with NICABATE. After drug was administered, patient experienced the following problems/side effects: asthma. NICABATE dosage: unknown. During the same period patient was treated with FLIXOTIDE. Patient recovered.

Nicabate Side Effects Report #5272715-7
NICABATE problem was reported by a Consumer or non-health professional from AUSTRALIA on Mar 13, 2007. Female patient was treated with NICABATE. After drug was administered, patient experienced the following problems/side effects: dependence, incorrect dose administered. NICABATE dosage: unknown. Patient recovered.


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anaphylactic reaction, application site rash, impaired driving ability, throat tightness, tremor, dependence, , was diagnosed with nerve injury, ill-defined disorder and was diagnosed with nerve injury, ill-defined disorder and