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Review Estradot Safety Reports submitted to FDA

Total Estradot reports: 18.
Estradot FDA safety alerts: No.
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FDA Reported Estradot Side Effects: hyperhidrosis, hypertension, hot flush, depression, feeling hot and cold, thyroidectomy, thyroid nodule removal, intervertebral disc protrusion, benign neoplasm of thyroid gland, back pain, anxiety.
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Estradot Side Effects Report #5669200-7
Consumer or non-health professional from AUSTRALIA reported ESTRADOT problem on Mar 05, 2008. Female patient was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident, feeling abnormal, headache. ESTRADOT dosage: unknown. Patient recovered.

Estradot Side Effects Report #5674166-X
ESTRADOT problem was reported by a Consumer or non-health professional from on Mar 17, 2008. Female patient was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: cardiac fibrillation, hot flush, nausea. ESTRADOT dosage: unknown. During the same period patient was treated with METOPROLOL TARTRATE. Patient recovered.

Estradot Side Effects Report #5675437-3
Consumer or non-health professional from reported ESTRADOT problem on Mar 17, 2008. Female patient was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: cardiac fibrillation, hot flush, nausea. ESTRADOT dosage: unknown. During the same period patient was treated with METOPROLOL TARTRATE. Patient recovered.

Estradot Side Effects Report #5678581-X
ESTRADOT problem was reported by a Consumer or non-health professional from AUSTRALIA on Mar 20, 2008. Female patient, 49 years of age, was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident, feeling abnormal, headache. ESTRADOT dosage: unknown. Patient recovered.


Estradot Side Effects Report #5599728-X
Physician from GERMANY reported ESTRADOT problem on Jan 17, 2008. Female patient, 69 years of age, was diagnosed with menopausal symptoms and was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: diplopia, extraocular muscle paresis, eye movement disorder. ESTRADOT dosage: unknown. Patient recovered.

Estradot Side Effects Report #5549735-8
ESTRADOT problem was reported by a Consumer or non-health professional from GERMANY on Dec 10, 2007. Female patient, 69 years of age, was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: diplopia, extraocular muscle paresis, eye movement disorder. ESTRADOT dosage: unknown. Patient recovered.

Estradot Side Effects Report #5444392-3
Consumer or non-health professional from BRAZIL reported ESTRADOT problem on Aug 29, 2007. Female patient, 56 years of age, weighting 121.3 lb, was diagnosed with hypertension and was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: anal haemorrhage, nervousness, vaginal haemorrhage. ESTRADOT dosage: unknown. During the same period patient was treated with ZETORETIC. Patient recovered.

Estradot Side Effects Report #5405669-0
ESTRADOT problem was reported by a Consumer or non-health professional from BRAZIL on July 25, 2007. Female patient, 54 years of age, weighting 189.6 lb, was diagnosed with depression and was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus, hyperhidrosis, hypertension. ESTRADOT dosage: unknown. During the same period patient was treated with PAMELOR. Patient recovered.

Estradot Side Effects Report #5413232-0
Consumer or non-health professional from BRAZIL reported ESTRADOT problem on Aug 09, 2007. Female patient, 42 years of age, weighting 136.7 lb, was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: asthenia, hot flush, muscle spasms, pain in extremity, weight decreased. ESTRADOT dosage: unknown. Patient died.


Estradot Side Effects Report #5693249-1
ESTRADOT problem was reported by a Consumer or non-health professional from AUSTRALIA on Mar 26, 2008. Female patient was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: depression, malaise. ESTRADOT dosage: unknown. Patient recovered.

Estradot Side Effects Report #5694202-4
Consumer or non-health professional from AUSTRALIA reported ESTRADOT problem on Mar 26, 2008. Female patient was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: depression, malaise. ESTRADOT dosage: unknown. Patient recovered.

Estradot Side Effects Report #5694462-X
ESTRADOT problem was reported by a Consumer or non-health professional from on Mar 27, 2008. Female patient, 66 years of age, weighting 134.5 lb, was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: breast mass. ESTRADOT dosage: unknown. Patient recovered.

Estradot Side Effects Report #5345241-4
Consumer or non-health professional from BRAZIL reported ESTRADOT problem on May 23, 2007. Female patient, 54 years of age, weighting 189.6 lb, was diagnosed with depression and was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: diabetes mellitus, hyperhidrosis, hypertension. ESTRADOT dosage: unknown. During the same period patient was treated with PAMELOR. Patient recovered.

Estradot Side Effects Report #5368189-8
ESTRADOT problem was reported by a Consumer or non-health professional from BRAZIL on June 15, 2007. Female patient was diagnosed with hypertension and was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: back pain, benign neoplasm of thyroid gland, intervertebral disc protrusion, thyroid nodule removal, thyroidectomy. ESTRADOT dosage: unknown. During the same period patient was treated with PROPRANOLOL, CALCIUM CARBONATE, ESTRADERM. Patient recovered.


Estradot Side Effects Report #5374328-5
Consumer or non-health professional from BRAZIL reported ESTRADOT problem on June 26, 2007. Female patient was diagnosed with hypertension and was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: back pain, benign neoplasm of thyroid gland, intervertebral disc protrusion, thyroid nodule removal, thyroidectomy. ESTRADOT dosage: unknown. During the same period patient was treated with PROPRANOLOL, CALCIUM CARBONATE, ESTRADERM. Patient recovered.

Estradot Side Effects Report #5333203-2
ESTRADOT problem was reported by a Consumer or non-health professional from BRAZIL on May 15, 2007. Female patient was diagnosed with hypertension and was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: back pain, benign neoplasm of thyroid gland, intervertebral disc protrusion, thyroid nodule removal, thyroidectomy. ESTRADOT dosage: unknown. During the same period patient was treated with PROPRANOLOL, CALCIUM CARBONATE, ESTRADERM. Patient recovered.

Estradot Side Effects Report #5262492-8
Consumer or non-health professional from BRAZIL reported ESTRADOT problem on Feb 28, 2007. Female patient, 51 years of age, weighting 127.9 lb, was diagnosed with menopause and was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: burning sensation, hot flush, hyperhidrosis, hypertension, malaise. ESTRADOT dosage: unknown. Patient recovered.

Estradot Side Effects Report #5276063-0
ESTRADOT problem was reported by a Consumer or non-health professional from BRAZIL on Mar 13, 2007. Female patient, 52 years of age, was treated with ESTRADOT. After drug was administered, patient experienced the following problems/side effects: clavicle fracture, road traffic accident. ESTRADOT dosage: 50 MG. Patient recovered.


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