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Review Nicardipine Safety Reports submitted to FDA

Total Nicardipine reports: 25.
Nicardipine FDA safety alerts: No.
Reported deaths: 4    Reported hospitalizations: 6.
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FDA Reported Nicardipine Side Effects: erythema multiforme, renal impairment, fall, neutropenia, arrhythmia, left ventricle outflow tract obstruction, haemolysis, malaise, platelet count decreased, haemodialysis, ileus paralytic.
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Nicardipine Side Effects Report #5682506-0
Pharmacist from UNITED STATES reported NICARDIPINE problem on Mar 26, 2008. Male patient, 63 years of age, weighting 215.6 lb, was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: hypotension. NICARDIPINE dosage: 25MG IV OTO. During the same period patient was treated with LACTULOSE, MITODRINE, CEFEPIME, OCTREOTIDE ACETATE, FENTANYL, VIT K. Patient died on 01/15/2008.

Nicardipine Side Effects Report #5660502-7
NICARDIPINE problem was reported by a Physician from UNITED STATES on May 23, 2007. Female patient, 40 years of age, was diagnosed with cerebrovascular spasm and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, heart rate increased. NICARDIPINE dosage: 3 MG DAILY INTRA-ARTERIAL. Patient recovered.

Nicardipine Side Effects Report #5660504-0
Physician from UNITED STATES reported NICARDIPINE problem on May 31, 2007. Female patient, 59 years of age, was diagnosed with cerebrovascular spasm and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. NICARDIPINE dosage: 3 MG DAILY INTRA-ARTERIAL. Patient recovered.

Nicardipine Side Effects Report #5660506-4
NICARDIPINE problem was reported by a Physician from UNITED STATES on May 31, 2007. Female patient, 46 years of age, was diagnosed with cerebrovascular spasm and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. NICARDIPINE dosage: 3 MG DAILY INTRA-ARTERIAL. Patient recovered.

Nicardipine Side Effects Report #5660508-8
Physician from UNITED STATES reported NICARDIPINE problem on May 31, 2007. Female patient, 51 years of age, was diagnosed with cerebrovascular spasm and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. NICARDIPINE dosage: 3 MG DAILY INTRA-ARTERIAL. Patient recovered.

Nicardipine Side Effects Report #5660510-6
NICARDIPINE problem was reported by a Physician from UNITED STATES on May 31, 2007. Female patient, 57 years of age, was diagnosed with cerebrovascular spasm and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. NICARDIPINE dosage: 3 MG DAILY INTRA-ARTERIAL. Patient recovered.

Nicardipine Side Effects Report #5660511-8
Physician from UNITED STATES reported NICARDIPINE problem on May 31, 2007. Female patient, 66 years of age, was diagnosed with cerebrovascular spasm and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. NICARDIPINE dosage: 3 MG DAILY INTRA-ARTERIAL. Patient recovered.

Nicardipine Side Effects Report #5660513-1
NICARDIPINE problem was reported by a Physician from UNITED STATES on May 31, 2007. Male patient, 36 years of age, was diagnosed with cerebrovascular spasm and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. NICARDIPINE dosage: 3 MG DAILY INTRA-ARTERIAL. Patient recovered.

Nicardipine Side Effects Report #5660728-2
Physician from UNITED STATES reported NICARDIPINE problem on May 31, 2007. Male patient, 49 years of age, was diagnosed with cerebrovascular spasm and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. NICARDIPINE dosage: 3 MG DAILY INTRA-ARTERIAL. Patient recovered.

Nicardipine Side Effects Report #5660755-5
NICARDIPINE problem was reported by a Physician from UNITED STATES on May 31, 2007. Male patient, 56 years of age, was diagnosed with cerebrovascular spasm and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. NICARDIPINE dosage: 3 MG DAILY INTRA-ARTERIAL. Patient recovered.

Nicardipine Side Effects Report #5660807-X
Physician from UNITED STATES reported NICARDIPINE problem on May 31, 2007. Female patient, 49 years of age, was diagnosed with cerebrovascular spasm and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. NICARDIPINE dosage: 3 MG DAILY INTRA-ARTERIAL. Patient recovered.

Nicardipine Side Effects Report #5660847-0
NICARDIPINE problem was reported by a Physician from UNITED STATES on May 31, 2007. Female patient, 59 years of age, was diagnosed with cerebrovascular spasm and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. NICARDIPINE dosage: 3 MG DAILY INTRA-ARTERIAL. Patient recovered.

Nicardipine Side Effects Report #5660877-9
Physician from UNITED STATES reported NICARDIPINE problem on May 31, 2007. Female patient, 66 years of age, was diagnosed with cerebrovascular spasm and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased. NICARDIPINE dosage: 3 MG DAILY NITRA-ARTERIAL. Patient recovered.

Nicardipine Side Effects Report #5577806-9
NICARDIPINE problem was reported by a Pharmacist from UNITED STATES on Dec 17, 2007. Female patient was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: extravasation. NICARDIPINE dosage: unknown. Patient was hospitalized. Patient recovered.

Nicardipine Side Effects Report #5524945-4
Health Professional from UNITED STATES reported NICARDIPINE problem on Nov 05, 2007. Female patient was diagnosed with hypertension and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: ecg signs of myocardial ischaemia. NICARDIPINE dosage: unknown. Patient recovered.

Nicardipine Side Effects Report #5484844-3
NICARDIPINE problem was reported by a Health Professional from FRANCE on Sept 26, 2007. Female patient, 28 years of age, was diagnosed with threatened labour and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, brain natriuretic peptide increased, dilatation ventricular, premature labour, troponin increased. NICARDIPINE dosage: unknown. Patient was hospitalized. Patient recovered.

Nicardipine Side Effects Report #5484845-5
Physician from FRANCE reported NICARDIPINE problem on Sept 26, 2007. Female patient was diagnosed with threatened labour and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, chorioamnionitis, diabetic complication, respiratory failure. NICARDIPINE dosage: unknown. Patient was hospitalized. Patient recovered.

Nicardipine Side Effects Report #5484846-7
NICARDIPINE problem was reported by a Physician from FRANCE on Sept 26, 2007. Female patient, 39 years of age, was diagnosed with threatened labour and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, caesarean section, electrocardiogram repolarisation abnormality, troponin increased, uterine atony. NICARDIPINE dosage: unknown. Patient was hospitalized. Patient recovered.

Nicardipine Side Effects Report #5484886-8
Physician from FRANCE reported NICARDIPINE problem on Sept 26, 2007. Female patient, 38 years of age, was diagnosed with threatened labour and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: acute pulmonary oedema, caesarean section. NICARDIPINE dosage: unknown. Patient was hospitalized. Patient recovered.

Nicardipine Side Effects Report #5413011-4
NICARDIPINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Jan 12, 2007. Female patient, 82 years of age, was diagnosed with hypertension and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: creatinine renal clearance decreased, dizziness, fall, headache, hypotonia, malaise, orthostatic hypotension. NICARDIPINE dosage: 20 MG;TID;PO. During the same period patient was treated with SPIRONOLACTONE, HYDROCHLOROTHIAZIDE, HALOPERIDOL, PARACETAMOL, SERETIDE, ZOLPIDEM TARTRATE. Patient was hospitalized. Patient recovered.

Nicardipine Side Effects Report #5429174-0
Consumer or non-health professional from JAPAN reported NICARDIPINE problem on Aug 07, 2007. Male patient, 89 years of age, was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, cardio-respiratory arrest, hypotension, malnutrition, overdose, oxygen saturation decreased. NICARDIPINE dosage: 60 MG (60 MG, 1 IN 1 ONCE), INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with GLUCOSE. Patient died.

Nicardipine Side Effects Report #5386099-7
NICARDIPINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 26, 2007. Male patient, 29 years of age, was diagnosed with hypertension and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, apparent life threatening event, colitis, disseminated intravascular coagulation, ileus. NICARDIPINE dosage: 10 MG; QH; IV. During the same period patient was treated with AMLODIPINE BESYLATE. Patient recovered.

Nicardipine Side Effects Report #5401933-X
Consumer or non-health professional from JAPAN reported NICARDIPINE problem on June 27, 2007. Male patient, 89 years of age, was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, hypotension, malnutrition, overdose, oxygen saturation decreased, poor peripheral circulation, respiratory arrest, resuscitation. NICARDIPINE dosage: 60 MG (60 MG, 1 IN 1 ONCE) INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with GLUCOSE. Patient died.

Nicardipine Side Effects Report #5386099-7
NICARDIPINE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 26, 2007. Male patient, 29 years of age, was diagnosed with hypertension and was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: abdominal pain, apparent life threatening event, colitis, disseminated intravascular coagulation, ileus. NICARDIPINE dosage: 10 MG; QH; IV. During the same period patient was treated with AMLODIPINE BESYLATE. Patient recovered.

Nicardipine Side Effects Report #5401933-X
Consumer or non-health professional from JAPAN reported NICARDIPINE problem on June 27, 2007. Male patient, 89 years of age, was treated with NICARDIPINE. After drug was administered, patient experienced the following problems/side effects: blood glucose decreased, hypotension, malnutrition, overdose, oxygen saturation decreased, poor peripheral circulation, respiratory arrest, resuscitation. NICARDIPINE dosage: 60 MG (60 MG, 1 IN 1 ONCE) INTRAVENOUS (NOT OTHERWISE SPECIFIED). During the same period patient was treated with GLUCOSE. Patient died.


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