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Femara Safety Reports reported to FDA

Total Femara reports: 342.
Femara FDA safety alerts: No.
Reported deaths: 20    Reported hospitalizations: 61.
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Reported Femara Side Effects: arthralgia, fatigue, condition aggravated, osteonecrosis, myalgia, hypertension, hot flush, asthenia, pain in extremity, bone pain, depression.
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Femara Side Effects Report #5357010-X
Health Professional from UNITED STATES reported FEMARA problem on June 12, 2007. Female patient, 52 years of age, weighting 178.0 lb, was diagnosed with breast disorder and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: rib fracture, road traffic accident. FEMARA dosage: 2.5 MG DAILY PO. During the same period patient was treated with TARCEVA. Patient recovered.

Femara Side Effects Report #5361548-9
FEMARA problem was reported by a Physician from GERMANY on June 06, 2007. Female patient, 64 years of age, weighting 238.1 lb, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, alanine aminotransferase increased, aspartate aminotransferase increased, blood lactate dehydrogenase increased, cytomegalovirus infection, cytomegalovirus test positive, dehydration, endoscopy upper gastrointestinal tract abnormal, epstein-barr virus antibody positive. FEMARA dosage: 2.5 MG. During the same period patient was treated with FUROSEMIDE, DECORTIN, DOXEPIN, ACETYLSALICYLIC ACID SRT, THEOPHYLLINE, EFEROX, MORPHINE, FLUPIRTINE MALEATE. Patient was hospitalized. Patient recovered.

Femara Side Effects Report #5363177-X
Physician from JAPAN reported FEMARA problem on June 14, 2007. Female patient, 70 years of age, weighting 70.55 lb, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: lung disorder. FEMARA dosage: 2.5 MG/D. During the same period patient was treated with NOLVADEX. Patient died on 05/13/2007.

Femara Side Effects Report #5363436-0
FEMARA problem was reported by a Physician from FRANCE on June 11, 2007. Female patient, 63 years of age, weighting 116.8 lb, was diagnosed with breast cancer, asthma, migraine, dyslipidaemia, osteoarthritis and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: haemoptysis, tongue cancer metastatic. FEMARA dosage: 2.5 MG PER DAY. During the same period patient was treated with DESLORATADINE, AVLOCARDYL, LESCOL, PIASCLEDINE, ART. Patient was hospitalized. Patient recovered.

Femara Side Effects Report #5363778-9
Consumer or non-health professional from UNITED STATES reported FEMARA problem on June 12, 2007. Female patient, 61 years of age, weighting 199.0 lb, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: arthralgia, cardiac flutter, diastolic dysfunction, electrocardiogram ambulatory, gait disturbance, heart rate irregular, joint injury, osteoarthritis, pain in extremity. FEMARA dosage: 2.5 MG, QD. During the same period patient was treated with VITAMIN CAP, GLUCOSAMINE, VITAMIN B CAP, ASPIRIN. Patient recovered.

Femara Side Effects Report #5364393-3
FEMARA problem was reported by a Consumer or non-health professional from UNITED STATES on June 12, 2007. Female patient, 61 years of age, weighting 199.0 lb, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: arthralgia, cardiac flutter, diastolic dysfunction, electrocardiogram ambulatory, gait disturbance, heart rate irregular, joint injury, osteoarthritis, pain in extremity. FEMARA dosage: 2.5 MG, QD. During the same period patient was treated with VITAMIN CAP, GLUCOSAMINE, VITAMIN B CAP, ASPIRIN. Patient recovered.

Femara Side Effects Report #5368625-7
Consumer or non-health professional from UNITED STATES reported FEMARA problem on June 21, 2007. Female patient, weighting 170.2 lb, was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: anxiety, depression, insomnia, memory impairment, metastasis. FEMARA dosage: 67.5 MG. Patient recovered.

Femara Side Effects Report #5370561-7
FEMARA problem was reported by a Consumer or non-health professional from JAPAN on June 22, 2007. Female patient, 61 years of age, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: pleural effusion, respiratory failure. FEMARA dosage: 2.5 MG/DAY. Patient died on 05/15/2007.

Femara Side Effects Report #5370597-6
Physician from GERMANY reported FEMARA problem on June 18, 2007. Female patient, 71 years of age, weighting 143.3 lb, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: palpitations, tachycardia. FEMARA dosage: 2.5 MG, QD. Patient recovered.

Femara Side Effects Report #5371628-X
FEMARA problem was reported by a Consumer or non-health professional from UNITED STATES on June 20, 2007. Female patient, 70 years of age, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: eye disorder, eye irritation, eye pain, lacrimation increased, visual acuity reduced. FEMARA dosage: 2.5 MG, QD. Patient recovered.

Femara Side Effects Report #5371652-7
Pharmacist from GERMANY reported FEMARA problem on June 21, 2007. Female patient was diagnosed with breast cancer female and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus non-insulin-dependent. FEMARA dosage: 2.5 MG, QD. During the same period patient was treated with METFORMIN, BETA BLOCKING AGENTS. Patient recovered.

Femara Side Effects Report #5375212-3
FEMARA problem was reported by a Physician from ITALY on June 20, 2007. Female patient, 73 years of age, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: gastric cancer, hepatic lesion, hepatic mass. FEMARA dosage: unknown. Patient recovered.

Femara Side Effects Report #5375335-9
Consumer or non-health professional from CANADA reported FEMARA problem on June 22, 2007. Female patient, 26 years of age, weighting 142.9 lb, was diagnosed with ovulation induction and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: breech presentation, caesarean section, normal newborn. FEMARA dosage: 2.5 MG ONCE A DAY FOR 5 DAYS. Patient was hospitalized. Patient recovered.

Femara Side Effects Report #5375345-1
FEMARA problem was reported by a Consumer or non-health professional from CANADA on June 22, 2007. Female patient, 26 years of age, weighting 142.9 lb, was diagnosed with ovulation induction and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: breech presentation, caesarean section, normal newborn. FEMARA dosage: 2.5 MG ONCE A DAY FOR 5 DAYS. Patient was hospitalized. Patient recovered.

Femara Side Effects Report #5042631-4
Physician from SPAIN reported FEMARA problem on May 09, 2006. Female patient, 56 years of age, was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: meniscus lesion, musculoskeletal disorder, tendonitis, trigger finger. FEMARA dosage: unknown. Patient recovered.

Femara Side Effects Report #5045030-4
FEMARA problem was reported by a Physician from GERMANY on Nov 14, 2005. Female patient, 62 years of age, weighting 165.3 lb, was diagnosed with metastases to bone and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: anaesthesia, bone disorder, bone trimming, facial pain, impaired healing, local anaesthesia, osteonecrosis, plastic surgery, tooth extraction. FEMARA dosage: unknown. During the same period patient was treated with ZOMETA. Patient was hospitalized. Patient recovered.

Femara Side Effects Report #5045779-3
Consumer or non-health professional from UNITED STATES reported FEMARA problem on Nov 29, 2005. Female patient, child 1 years of age, was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: neuroblastoma. FEMARA dosage: unknown. Patient recovered.

Femara Side Effects Report #5045789-6
FEMARA problem was reported by a Physician from FRANCE on July 06, 2006. Female patient, 60 years of age, was diagnosed with breast cancer recurrent and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: asthenia, hepatitis, transaminases increased. FEMARA dosage: 2.5 MG, QD. Patient was hospitalized. Patient died.

Femara Side Effects Report #5046019-1
Physician from GERMANY reported FEMARA problem on June 30, 2006. Female patient, 68 years of age, was diagnosed with breast cancer metastatic and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: ileus, surgery. FEMARA dosage: 2.5 MG, QD. Patient was hospitalized. Patient recovered.

Femara Side Effects Report #5046272-4
FEMARA problem was reported by a Physician from GERMANY on Nov 14, 2005. Female patient, 62 years of age, weighting 165.3 lb, was diagnosed with metastases to bone and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: anaesthesia, bone disorder, bone trimming, facial pain, impaired healing, local anaesthesia, osteonecrosis, plastic surgery, tooth extraction. FEMARA dosage: unknown. During the same period patient was treated with ZOMETA. Patient was hospitalized. Patient recovered.

Femara Side Effects Report #5047642-0
Consumer or non-health professional from UNITED STATES reported FEMARA problem on July 05, 2006. Female patient, 62 years of age, weighting 145.0 lb, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: anxiety, asthenia, back pain, depression, feeling abnormal, insomnia, myalgia. FEMARA dosage: 2.5 MG 1XDAY PO. Patient recovered.

Femara Side Effects Report #5051042-7
FEMARA problem was reported by a Consumer or non-health professional from UNITED KINGDOM on July 04, 2006. Female patient was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: amnesia. FEMARA dosage: 2.5 MG/DAY. Patient recovered.

Femara Side Effects Report #5053605-1
Physician from GERMANY reported FEMARA problem on Feb 24, 2006. Female patient, 74 years of age, weighting 110.2 lb, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: dental prosthesis user, dental treatment, osteonecrosis. FEMARA dosage: 2.5 MG, QD. During the same period patient was treated with ZOMETA. Patient recovered.

Femara Side Effects Report #5054723-4
FEMARA problem was reported by a Health Professional from UNITED STATES on May 28, 2006. Female patient, 57 years of age, was diagnosed with endometrial cancer stage i and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: arthralgia, arthritis, hip arthroplasty, osteonecrosis. FEMARA dosage: 2.5 MG, QD. Patient was hospitalized. Patient recovered.

Femara Side Effects Report #5059342-1
Consumer or non-health professional from UNITED KINGDOM reported FEMARA problem on July 12, 2006. Female patient was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: oral pain, stomatitis. FEMARA dosage: 2.5 MG/DAY. Patient recovered.

Femara Side Effects Report #5059343-3
FEMARA problem was reported by a Pharmacist from UNITED KINGDOM on July 12, 2006. Female patient was diagnosed with endometrial cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: hyperproteinaemia, protein total increased. FEMARA dosage: 2.5MG/DAY. Patient recovered.

Femara Side Effects Report #5064223-3
Health Professional from UNITED STATES reported FEMARA problem on July 17, 2006. Female patient was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: blood cholesterol increased, blood triglycerides increased. FEMARA dosage: 2.5 MG, QD. Patient recovered.

Femara Side Effects Report #5064225-7
FEMARA problem was reported by a Physician from SWITZERLAND on July 18, 2006. Female patient, 81 years of age, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: necrosis. FEMARA dosage: unknown. Patient recovered.

Femara Side Effects Report #5064228-2
Physician from FRANCE reported FEMARA problem on July 17, 2006. Female patient, 50 years of age, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: amaurosis fugax, retinal vein thrombosis. FEMARA dosage: 2.5 MG, QD. Patient recovered.

Femara Side Effects Report #5065414-8
FEMARA problem was reported by a Health Professional from UNITED KINGDOM on July 04, 2006. Female patient, 72 years of age, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: amnesia. FEMARA dosage: 2.5 MG/DAY. Patient recovered.

Femara Side Effects Report #5065422-7
Physician from GERMANY reported FEMARA problem on Mar 03, 2006. Female patient, 81 years of age, was diagnosed with breast cancer metastatic and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: arthralgia, fall, subarachnoid haemorrhage. FEMARA dosage: 2.5 MG, QD. Patient was hospitalized. Patient recovered.

Femara Side Effects Report #5065426-4
FEMARA problem was reported by a Consumer or non-health professional from UNITED STATES on July 26, 2006. Female patient, 55 years of age, weighting 140.0 lb, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: dupuytren's contracture, hyperkeratosis, skin hypertrophy, skin lesion. FEMARA dosage: unknown. During the same period patient was treated with XELODA. Patient recovered.

Femara Side Effects Report #5071692-1
Consumer or non-health professional from UNITED STATES reported FEMARA problem on Mar 29, 2004. Female patient, 51 years of age, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: bone disorder, impaired healing, osteonecrosis, pain in jaw, tooth extraction. FEMARA dosage: 2.5 MG, QD. During the same period patient was treated with CELEBREX, AREDIA, CALCIUM CARBONATE, VITAMINS, OXYCONTIN, OXYCODONE, ZOFRAN, COMPAZINE. Patient recovered.

Femara Side Effects Report #5076013-6
FEMARA problem was reported by a Physician from UNITED STATES on Aug 08, 2006. Female patient, 49 years of age, weighting 221.0 lb, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: chest pain, dyspnoea exertional. FEMARA dosage: 2.5 MG DAILY PO. Patient recovered.

Femara Side Effects Report #5077969-8
Physician from BELGIUM reported FEMARA problem on July 06, 2006. Female patient was diagnosed with breast cancer metastatic and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: mental disorder. FEMARA dosage: unknown. Patient was hospitalized. Patient recovered.

Femara Side Effects Report #5077970-4
FEMARA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 27, 2006. Female patient, 51 years of age, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: hot flush, mastectomy, musculoskeletal stiffness, tinnitus. FEMARA dosage: 2.5 MG, QD. During the same period patient was treated with ZOLADEX. Patient recovered.

Femara Side Effects Report #5078099-1
Consumer or non-health professional from UNITED STATES reported FEMARA problem on July 28, 2006. Female patient, 59 years of age, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: arthralgia, arthropathy, dizziness, fatigue, joint swelling, osteoarthritis. FEMARA dosage: unknown. Patient recovered.

Femara Side Effects Report #5079021-4
FEMARA problem was reported by a Pharmacist from UNITED STATES on Aug 02, 2006. Female patient, 91 years of age, was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: blood creatinine increased, blood urea increased, pneumonia, renal failure acute. FEMARA dosage: unknown. Patient was hospitalized. Patient recovered.

Femara Side Effects Report #5079022-6
Consumer or non-health professional from UNITED STATES reported FEMARA problem on Aug 07, 2006. Female patient, 73 years of age, was diagnosed with breast cancer metastatic and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: aphasia, asthenia, back pain, cerebrovascular accident, hemiparesis, metastases to urinary tract. FEMARA dosage: 2.5 MG, QD. Patient was hospitalized. Patient died on 09/30/2005.

Femara Side Effects Report #5079023-8
FEMARA problem was reported by a Physician from UNITED STATES on Aug 03, 2006. Female patient, 57 years of age, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: hypoaesthesia, neuropathy. FEMARA dosage: 2.5 MG, QD. During the same period patient was treated with SELDANE, ADVIL. Patient recovered.

Femara Side Effects Report #5079367-X
Consumer or non-health professional from AUSTRALIA reported FEMARA problem on July 18, 2006. Female patient, 53 years of age, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: arthralgia, fatigue, heart rate irregular. FEMARA dosage: unknown. Patient recovered.

Femara Side Effects Report #5079844-1
FEMARA problem was reported by a Pharmacist from PORTUGAL on Aug 03, 2006. Female patient was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: arthritis, lupus-like syndrome. FEMARA dosage: 2.5 MG/D. Patient recovered.

Femara Side Effects Report #5079845-3
Health Professional from UNITED STATES reported FEMARA problem on June 07, 2006. Female patient, weighting 169.0 lb, was diagnosed with breast cancer, promotion of peripheral circulation, gastrooesophageal reflux disease, hypothyroidism, blood cholesterol increased and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: breast reconstruction, weight increased. FEMARA dosage: 2.5 MG, QD. During the same period patient was treated with COUMADIN, PREVACID, SYNTHROID, LIPITOR. Patient recovered.

Femara Side Effects Report #5081664-9
FEMARA problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 08, 2006. Female patient, 49 years of age, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: arthralgia, condition aggravated, rheumatoid arthritis. FEMARA dosage: 2.5 MG, QD. Patient recovered.

Femara Side Effects Report #5083654-9
Consumer or non-health professional from UNITED STATES reported FEMARA problem on May 25, 2006. Female patient, 52 years of age, weighting 234.0 lb, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, dyspnoea, loss of consciousness, pharyngeal oedema, rash, syncope, urticaria. FEMARA dosage: unknown. Patient recovered.

Femara Side Effects Report #5086329-5
FEMARA problem was reported by a Physician from UNITED STATES on Aug 07, 2006. Female patient, 73 years of age, was diagnosed with breast cancer metastatic and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: aphasia, asthenia, back pain, cerebrovascular accident, dehydration, hemiparesis, hypotension, metastases to urinary tract. FEMARA dosage: 2.5 MG, QD. During the same period patient was treated with AROMASIN, TAXOTERE. Patient was hospitalized. Patient died on 09/30/2005.

Femara Side Effects Report #5086331-3
Physician from GERMANY reported FEMARA problem on May 10, 2006. Female patient, weighting 110.2 lb, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: cerebral atrophy, cognitive disorder, dementia, dementia alzheimer's type, memory impairment, nuclear magnetic resonance imaging abnormal. FEMARA dosage: unknown. Patient recovered.

Femara Side Effects Report #5087283-2
FEMARA problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 17, 2006. Female patient, 72 years of age, weighting 150.0 lb, was diagnosed with breast cancer and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: cataract, deafness, lens implant, scar. FEMARA dosage: 2.5 MG, QD. During the same period patient was treated with VITAMINS, MINERALS NOS. Patient recovered.

Femara Side Effects Report #5087812-9
Health Professional from GERMANY reported FEMARA problem on Feb 24, 2006. Female patient, 74 years of age, weighting 110.2 lb, was diagnosed with breast cancer, breast cancer metastatic and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: dental prosthesis user, dental treatment, osteonecrosis. FEMARA dosage: 2.5 MG, QD. During the same period patient was treated with ZOMETA. Patient recovered.

Femara Side Effects Report #5089001-0
FEMARA problem was reported by a Physician from UNITED STATES on Jan 26, 2006. Female patient, 71 years of age, was diagnosed with breast cancer, metastases to bone and was treated with FEMARA. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, beta haemolytic streptococcal infection, blood culture positive, body temperature decreased, bone pain, cellulitis, decreased appetite, disorientation, fatigue. FEMARA dosage: 2.5 MG, QD. During the same period patient was treated with NEURONTIN, SKELAXIN, ELAVIL, ZOLEDRONATE. Patient was hospitalized. Patient recovered.

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