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Review Pritor Safety Reports submitted to FDA

Total Pritor reports: 17.
Pritor FDA safety alerts: No.
   Reported hospitalizations: 15.
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FDA Reported Pritor Side Effects: tendonitis, pain in extremity, myalgia, muscle spasms, arthralgia, asthenia, hyponatraemia, epilepsy, dehydration, hypotension, fall.
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Pritor Side Effects Report #5625119-9
Consumer or non-health professional from reported PRITOR problem on Feb 04, 2008. Male patient, 74 years of age, was diagnosed with hypertension and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: atrioventricular block second degree. PRITOR dosage: unknown. During the same period patient was treated with TRITACE, HYDROCHLOROTHIAZIDE, MONONIT RETARD, MOLSIDOMINA, PREDUCTAL MR, DIURETICS NOS, ACE INHIBITORS NOS. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5633862-0
PRITOR problem was reported by a Consumer or non-health professional from on Feb 19, 2008. Male patient, 74 years of age, was diagnosed with hypertension and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: atrioventricular block second degree. PRITOR dosage: unknown. During the same period patient was treated with TRITACE, HYDROCHLOROTHIAZIDE, MONONIT RETARD, MOLSIDOMINA, PREDUCTAL MR, DIURETICS NOS, ACE INHIBITORS NOS. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5442782-6
Health Professional from reported PRITOR problem on Aug 28, 2007. Male patient, 83 years of age, was diagnosed with prostate cancer and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: dizziness, hyponatraemia, nausea, tinnitus, vomiting. PRITOR dosage: unknown. During the same period patient was treated with ANANDRON, XATRAL, NOVONORM. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5464557-4
PRITOR problem was reported by a Physician from on Sept 13, 2007. Male patient, 77 years of age, was diagnosed with hypertension and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: asthenia, back pain, decreased appetite, fall, hypotension. PRITOR dosage: unknown. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5467511-1
Physician from reported PRITOR problem on Sept 24, 2007. Male patient, 77 years of age, was diagnosed with hypertension and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: asthenia, back pain, decreased appetite, fall, hypotension. PRITOR dosage: unknown. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5413972-3
PRITOR problem was reported by a Health Professional from on Aug 07, 2007. Female patient, 67 years of age, was diagnosed with hypertension and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: toxic skin eruption. PRITOR dosage: unknown. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5426883-4
Physician from reported PRITOR problem on Aug 20, 2007. Female patient, 66 years of age, was diagnosed with hypertension and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: arthralgia, muscle spasms, myalgia, pain in extremity, tendon pain, tendonitis. PRITOR dosage: unknown. During the same period patient was treated with PRITOR PLUS, ISOPTIN, BRONCHODUAL, LANSOPRAZOLE. Patient recovered.

Pritor Side Effects Report #5317238-1
PRITOR problem was reported by a Health Professional from on Apr 17, 2007. Male patient, 83 years of age, was diagnosed with prostate cancer and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: dizziness, hyponatraemia, nausea, tinnitus, vomiting. PRITOR dosage: unknown. During the same period patient was treated with ANANDRON, XATRAL, NOVONORM. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5327919-1
Health Professional from reported PRITOR problem on May 09, 2007. Female patient, 85 years of age, was diagnosed with essential hypertension, diabetes mellitus, hyperlipidaemia and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: dehydration. PRITOR dosage: unknown. During the same period patient was treated with DIANBEN, EUGLUCON, PANTOK. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5329115-0
PRITOR problem was reported by a Health Professional from on May 09, 2007. Female patient, 85 years of age, was diagnosed with essential hypertension, diabetes mellitus, hyperlipidaemia and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: dehydration. PRITOR dosage: unknown. During the same period patient was treated with DIANBEN, EUGLUCON, PANTOK. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5334040-5
Health Professional from reported PRITOR problem on May 17, 2007. Female patient, 67 years of age, was diagnosed with hypertension and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: toxic skin eruption. PRITOR dosage: unknown. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5293630-9
PRITOR problem was reported by a Health Professional from on Mar 28, 2007. Male patient, 74 years of age, was diagnosed with epilepsy, anxiety and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: epilepsy. PRITOR dosage: unknown. During the same period patient was treated with FONZYLANE, MIANSERINE, ARTANE, DEPAKENE, TEMESTA, EQUANIL. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5310284-3
Health Professional from FRANCE reported PRITOR problem on Apr 17, 2007. Male patient, 83 years of age, was diagnosed with hypertension, diabetes mellitus, prostate cancer and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: hyponatraemia, vestibular disorder. PRITOR dosage: unknown. During the same period patient was treated with NOVONORM, ANANDRON, XATRAL. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5310438-6
PRITOR problem was reported by a Health Professional from on Apr 17, 2007. Male patient, 83 years of age, was diagnosed with prostate cancer and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: dizziness, dizziness postural, hyponatraemia, nausea, tinnitus, vomiting. PRITOR dosage: unknown. During the same period patient was treated with ANANDRON, XATRAL, NOVONORM. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5255606-7
Consumer or non-health professional from reported PRITOR problem on Feb 13, 2007. Male patient, 67 years of age, was diagnosed with hypertension and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: acute coronary syndrome, multiple sclerosis relapse. PRITOR dosage: unknown. During the same period patient was treated with METOCARD, EFFOX, ENARENAL. Patient was hospitalized. Patient recovered.

Pritor Side Effects Report #5258127-0
PRITOR problem was reported by a Physician from on Jan 24, 2007. Male patient, 48 years of age, was diagnosed with hypertension and was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: platelet count decreased. PRITOR dosage: unknown. Patient recovered.

Pritor Side Effects Report #5261128-X
Health Professional from reported PRITOR problem on Feb 21, 2007. Male patient, 74 years of age, was treated with PRITOR. After drug was administered, patient experienced the following problems/side effects: epilepsy. PRITOR dosage: unknown. During the same period patient was treated with FONZYLANE, MIANSERINE, ARTANE, DEPAKENE, TEMESTA, EQUANIL, KARDEGIC. Patient was hospitalized. Patient recovered.


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atrioventricular block second degree, atrioventricular block second degree, dizziness, hyponatraemia, nausea, tinnitus, vomiting, , was diagnosed with hypertension and was diagnosed with hypertension and was diagnosed with prostate cancer and