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Florinef Safety Reports submitted to FDA

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Total Florinef reports: 21.
Florinef FDA safety alerts: No.
   Reported hospitalizations: 10.
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FDA Reported Florinef Side Effects: dehydration, fatigue, somnolence, helicobacter infection, gastric ulcer, blood pressure decreased, asthenia, anorexia, hypokalaemia, blood potassium decreased, dizziness.
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Florinef Side Effects Report #5237842-9
Consumer or non-health professional from UNITED STATES reported FLORINEF problem on Feb 01, 2007. Female patient was diagnosed with syncope vasovagal and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, blood creatine phosphokinase increased, chest pain, coronary artery stenosis, ejection fraction decreased, electrocardiogram abnormal, hypertension, troponin increased. FLORINEF dosage: .2 MG, QD. During the same period patient was treated with AMLODIPINE, PERINDOPRIL ERBUMINE, LIPITOR. Patient was hospitalized. Patient recovered.

Florinef Side Effects Report #5344110-3
FLORINEF problem was reported by a Consumer or non-health professional from SPAIN on May 21, 2007. Female patient was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, addison's disease, anorexia, asthenia, blood potassium increased, blood pressure decreased, dehydration, grand mal convulsion. FLORINEF dosage: .15 MG, QD. During the same period patient was treated with LITHIUM CARBONATE, PERICIAZINE, LORAZEPAM, HYDROCORTISONE. Patient was hospitalized. Patient recovered.

Florinef Side Effects Report #5355732-8
Consumer or non-health professional from SPAIN reported FLORINEF problem on May 31, 2007. Female patient was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, addison's disease, anorexia, asthenia, blood potassium increased, blood pressure decreased, dehydration, dizziness. FLORINEF dosage: .15 MG, QD. During the same period patient was treated with LITHIUM CARBONATE, PERICIAZINE, LORAZEPAM, HYDROCORTISONE. Patient was hospitalized. Patient recovered.

Florinef Side Effects Report #5045276-5
FLORINEF problem was reported by a Pharmacist from AUSTRALIA on June 28, 2006. Female patient, 14 years of age, was diagnosed with hypotension and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: angioneurotic oedema. FLORINEF dosage: unknown. Patient recovered.

Florinef Side Effects Report #5064250-6
Health Professional from UNITED STATES reported FLORINEF problem on July 26, 2006. Female patient, 53 years of age, weighting 106.0 lb, was diagnosed with hypotension and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: contraindication to medical treatment, unevaluable event. FLORINEF dosage: unknown. Patient recovered.

Florinef Side Effects Report #5081123-3
FLORINEF problem was reported by a Pharmacist from AUSTRALIA on Apr 04, 2006. Female patient, 47 years of age, weighting 121.3 lb, was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: asthenia, blood pressure decreased, dehydration, dyspnoea. FLORINEF dosage: unknown. During the same period patient was treated with HYDROCORTISONE, ANTIDEPRESSANT. Patient was hospitalized. Patient recovered.

Florinef Side Effects Report #5129344-5
Consumer or non-health professional from UNITED STATES reported FLORINEF problem on Oct 04, 2006. Female patient, 92 years of age, was diagnosed with dementia alzheimer's type and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: blood potassium decreased, dehydration, fatigue, gastric ulcer, helicobacter infection, somnolence. FLORINEF dosage: .1 MG, BID. During the same period patient was treated with NAMENDA, REMINYL, LIPITOR. Patient was hospitalized. Patient recovered.

Florinef Side Effects Report #5144134-5
FLORINEF problem was reported by a Consumer or non-health professional from UNITED STATES on Oct 04, 2006. Female patient, 92 years of age, was diagnosed with hypotension, dementia alzheimer's type and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: blood potassium decreased, dehydration, fatigue, gastric ulcer, helicobacter infection, somnolence. FLORINEF dosage: .1 MG, BID. During the same period patient was treated with NAMENDA, REMINYL, LIPITOR. Patient was hospitalized. Patient recovered.

Florinef Side Effects Report #5179134-2
Consumer or non-health professional from UNITED STATES reported FLORINEF problem on Oct 04, 2006. Female patient, 92 years of age, was diagnosed with hypotension, dementia alzheimer's type and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: dehydration, fatigue, gastric ulcer, helicobacter infection, hypokalaemia, somnolence. FLORINEF dosage: .1 MG, BID. During the same period patient was treated with NAMENDA, REMINYL, LIPITOR, BACTRIM. Patient was hospitalized. Patient recovered.

Florinef Side Effects Report #5400458-5
FLORINEF problem was reported by a Consumer or non-health professional from UNITED STATES on July 20, 2007. Female patient was diagnosed with adrenogenital syndrome and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: hyperkalaemia, hypernatraemia. FLORINEF dosage: .1 MG, QD. Patient was hospitalized. Patient recovered.

Florinef Side Effects Report #5412625-5
Consumer or non-health professional from AUSTRALIA reported FLORINEF problem on Aug 01, 2007. Female patient was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: hypokalaemia, orthostatic hypotension. FLORINEF dosage: unknown. During the same period patient was treated with BICARBONATE W, ASPIRIN, TEMAZEPAM, CITALOPRAM HYDROBROMIDE, DOMPERIDONE, RABEPRAZOLE. Patient was hospitalized. Patient recovered.

Florinef Side Effects Report #5419334-7
FLORINEF problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 09, 2007. Female patient was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident, dysphagia. FLORINEF dosage: unknown. During the same period patient was treated with ASPIRIN, FOLIC ACID, MOVICOL, GLYCERYL TRINITRATE, PARACETAMOL, LANSOPRAZOLE, ATORVASTATIN CALCIUM. Patient was hospitalized. Patient recovered.

Florinef Side Effects Report #5430661-X
Consumer or non-health professional from UNITED STATES reported FLORINEF problem on Aug 28, 2006. Female patient was diagnosed with autonomic nervous system imbalance and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: depression, joint swelling, muscular weakness, skin discolouration, visual acuity reduced. FLORINEF dosage: .1 MG, QOD. During the same period patient was treated with PAXIL. Patient recovered.

Florinef Side Effects Report #5430662-1
FLORINEF problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 22, 2006. Female patient was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: false negative laboratory result. FLORINEF dosage: .1 MG, BID. During the same period patient was treated with ADVAIR DISKUS, FLONASE. Patient recovered.

Florinef Side Effects Report #5430663-3
Consumer or non-health professional from UNITED STATES reported FLORINEF problem on Aug 15, 2006. Female patient was diagnosed with addison's disease and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: blood pressure systolic increased. FLORINEF dosage: .1 MG, BID. During the same period patient was treated with COUMADIN, AMIODARONE, FOLVITE, EYE DROPS, LIPITOR. Patient recovered.

Florinef Side Effects Report #5430664-5
FLORINEF problem was reported by a Physician from UNITED STATES on Mar 22, 2007. Female patient was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: musculoskeletal pain. FLORINEF dosage: .1 MG, UNK. Patient recovered.

Florinef Side Effects Report #5430665-7
Consumer or non-health professional from UNITED STATES reported FLORINEF problem on Feb 26, 2007. Female patient was diagnosed with postural orthostatic tachycardia syndrome and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: dysuria. FLORINEF dosage: .1 MG, QD. During the same period patient was treated with NADOLOL. Patient recovered.

Florinef Side Effects Report #5430666-9
FLORINEF problem was reported by a Consumer or non-health professional from UNITED STATES on Feb 05, 2007. Female patient was diagnosed with orthostatic hypertension, multiple sclerosis, mineral supplementation and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: blood pressure fluctuation, fatigue, hot flush. FLORINEF dosage: .1 MG, TIW. During the same period patient was treated with COPAXONE, VITAMIN C, VITAMIN CAP, SELENIUM SULFIDE. Patient recovered.

Florinef Side Effects Report #5463343-9
Physician from IRELAND reported FLORINEF problem on Sept 12, 2007. Female patient, 60 years of age, was diagnosed with osteoporosis and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: anorexia, dizziness, nausea, pruritus, vomiting. FLORINEF dosage: unknown. During the same period patient was treated with FRUMIL, CALCICHEW, PARALIEF, ENSURE PLUS, ZIMOVANE, NEXIUM, FORTEO. Patient recovered.

Florinef Side Effects Report #5467987-X
FLORINEF problem was reported by a Pharmacist from UNITED STATES on Sept 25, 2007. Female patient, 22 years of age, weighting 136.0 lb, was diagnosed with orthostatic hypotension and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: breast pain. FLORINEF dosage: 0.1 MG ONCE DAILY BY MOUTH. Patient recovered.

Florinef Side Effects Report #5468562-3
Pharmacist from DENMARK reported FLORINEF problem on Sept 17, 2007. Female patient was diagnosed with adrenalectomy and was treated with FLORINEF. After drug was administered, patient experienced the following problems/side effects: swelling face, weight increased. FLORINEF dosage: unknown. During the same period patient was treated with HYDROCORTISONE, PANCREAS, TARGIN, BISOHEXAL, ASPIRIN, AMLODIPINE, RANIBETA, INSIDON. Patient recovered.

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