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Review Nebivolol Safety Reports submitted to FDA

Total Nebivolol reports: 5.
Nebivolol FDA safety alerts: No.
   Reported hospitalizations: 1.
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FDA Reported Nebivolol Side Effects:
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Nebivolol Side Effects Report #5678151-3
Physician from FRANCE reported NEBIVOLOL problem on Mar 04, 2008. Female patient, 56 years of age, was diagnosed with essential hypertension, musculoskeletal pain, mixed hyperlipidaemia and was treated with NEBIVOLOL. After drug was administered, patient experienced the following problems/side effects: cytolytic hepatitis. NEBIVOLOL dosage: 5 MG;DAILY; ORAL. During the same period patient was treated with METHOTREXATE, ACECLOFENAC, FENOFIBRATE, ACETAMINOPHEN. Patient recovered.

Nebivolol Side Effects Report #5623854-X
NEBIVOLOL problem was reported by a Physician from FRANCE on Jan 17, 2008. Female patient, 63 years of age, weighting 134.5 lb, was diagnosed with hypertension and was treated with NEBIVOLOL. After drug was administered, patient experienced the following problems/side effects: arthralgia, hypokinesia, myalgia, systemic lupus erythematosus. NEBIVOLOL dosage: 5 MG DAILY ORAL. During the same period patient was treated with PROPRANOLOL, HYZAAR, PAROXETINE, ESTRADIOL TRANSDERMAL. Patient recovered.

Nebivolol Side Effects Report #5797327-8
Physician from UNITED KINGDOM reported NEBIVOLOL problem on June 14, 2008. Female patient, 53 years of age, was diagnosed with hypertension and was treated with NEBIVOLOL. After drug was administered, patient experienced the following problems/side effects: lip swelling. NEBIVOLOL dosage: unknown. During the same period patient was treated with INDAPAMIDE, AMLODIPINE. Patient recovered.

Nebivolol Side Effects Report #5741405-6
NEBIVOLOL problem was reported by a Physician from SWITZERLAND on Apr 29, 2008. Male patient, 62 years of age, was diagnosed with essential hypertension, depression and was treated with NEBIVOLOL. After drug was administered, patient experienced the following problems/side effects: syncope, tremor. NEBIVOLOL dosage: unknown. During the same period patient was treated with TRAZODONE HYDROCHLORIDE, SORTIS, EFFEXOR. Patient was hospitalized. Patient recovered.

Nebivolol Side Effects Report #5715770-X
Physician from FRANCE reported NEBIVOLOL problem on Apr 07, 2008. Male patient was diagnosed with cardiac failure and was treated with NEBIVOLOL. After drug was administered, patient experienced the following problems/side effects: alcohol interaction, loss of consciousness, malaise. NEBIVOLOL dosage: 5 MG; DAILY; ORAL. During the same period patient was treated with VIAGRA. Patient recovered.


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cytolytic hepatitis, arthralgia, hypokinesia, myalgia, systemic lupus erythematosus, lip swelling, , was diagnosed with essential hypertension, musculoskeletal pain, mixed hyperlipidaemia and was diagnosed with hypertension and