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Testosterone Safety Reports submitted to FDA

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Total Testosterone reports: 16.
Testosterone FDA safety alerts: 2002 2004 .
   Reported hospitalizations: 4.
Take Testosterone Side Effects Survey or Share Your Testosterone Story.
Reported Testosterone Side Effects: breast cancer male, dyspnoea, rash, oestrogen receptor assay positive, retching, pharyngeal oedema, injection site pain, injection site erythema, hypoaesthesia, feeling hot, anaphylactic reaction.
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Testosterone Side Effects Report #5238070-3
Pharmacist from UNITED STATES reported TESTOSTERONE problem on Feb 09, 2007. Male patient, weighting 260.1 lb, was diagnosed with blood testosterone decreased and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: injection site abscess sterile. TESTOSTERONE dosage: 300MG Q3 WEEKS IM. During the same period patient was treated with CHLORPHENIRAMINE MALEATE, OMEGA, ZOLOFT, TERAZOSIN, LEVITRA, LOPID. Patient recovered.

Testosterone Side Effects Report #5282967-5
TESTOSTERONE problem was reported by a Pharmacist from UNITED STATES on Mar 28, 2007. Male patient, 84 years of age, weighting 147.5 lb, was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: rash. TESTOSTERONE dosage: unknown. Patient recovered.

Testosterone Side Effects Report #5345599-6
Consumer or non-health professional from UNITED STATES reported TESTOSTERONE problem on Mar 16, 2006. Male patient, weighting 180.8 lb, was diagnosed with blood testosterone decreased, erectile dysfunction and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, blood testosterone abnormal, blood testosterone decreased, high density lipoprotein decreased, hyperlipidaemia, low density lipoprotein increased. TESTOSTERONE dosage: unknown. During the same period patient was treated with TICLOPIDINE, CRESTOR, ZETIA, NEXIUM, NIACIN, ASPIRIN, CO Q. Patient recovered.

Testosterone Side Effects Report #5331804-9
TESTOSTERONE problem was reported by a Health Professional from UNITED STATES on May 09, 2007. Male patient, 36 years of age, was diagnosed with blood testosterone decreased and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: fasciitis, injection site cellulitis. TESTOSTERONE dosage: 1 ML, SINGLE, RIGHT THIGH, INTRAMUSCULAR. During the same period patient was treated with TESTOSTERONE ENANTHATE, BENICAR, CODEINE SUL, OXYCODONE. Patient was hospitalized. Patient recovered.

Testosterone Side Effects Report #5339595-2
Pharmacist from UNITED STATES reported TESTOSTERONE problem on May 29, 2007. Male patient, 55 years of age, was diagnosed with blood testosterone decreased and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: therapeutic response decreased. TESTOSTERONE dosage: 200 MG IM Q 2 WEEKS. During the same period patient was treated with VARDENAFIL. Patient recovered.

Testosterone Side Effects Report #5370033-X
TESTOSTERONE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 15, 2007. Male patient was diagnosed with androgen deficiency, hypertension, atrial fibrillation, irritable bowel syndrome, dysuria and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: escherichia urinary tract infection, haematocrit increased, prostatic disorder. TESTOSTERONE dosage: unknown. During the same period patient was treated with ENALAPRIL, WARFARIN, CODEINE SUL, ALFUZOSIN. Patient was hospitalized. Patient recovered.

Testosterone Side Effects Report #5052642-0
Pharmacist from UNITED STATES reported TESTOSTERONE problem on July 12, 2006. Male patient, 57 years of age, weighting 167.1 lb, was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: rash. TESTOSTERONE dosage: unknown. Patient recovered.

Testosterone Side Effects Report #5069869-4
TESTOSTERONE problem was reported by a Physician from UNITED STATES on Aug 02, 2006. Male patient, 70 years of age, weighting 296.0 lb, was diagnosed with hypogonadism and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: cardiomyopathy, cellulitis, dyspnoea, oedema peripheral. TESTOSTERONE dosage: 200 MG /ML Q2 WEEKS IM. Patient recovered.

Testosterone Side Effects Report #5128832-5
Physician from UNITED STATES reported TESTOSTERONE problem on Oct 06, 2006. Male patient was diagnosed with benign prostatic hyperplasia and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, cardiac arrest, cardio-respiratory arrest, hyperhidrosis, loss of consciousness, pulse absent. TESTOSTERONE dosage: unknown. During the same period patient was treated with MICARDIS, METFORMIN, UROXATRAL. Patient was hospitalized. Patient recovered.

Testosterone Side Effects Report #5130031-8
TESTOSTERONE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on Oct 04, 2006. Male patient, 52 years of age, was diagnosed with hypogonadism and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: blood testosterone increased, chorioretinopathy. TESTOSTERONE dosage: 500 MG, MONTHLY, INTRAVENOUS. Patient recovered.

Testosterone Side Effects Report #5133221-3
Health Professional from POLAND reported TESTOSTERONE problem on Oct 13, 2006. Male patient, weighting 194.0 lb, was diagnosed with hypogonadism male and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: breast cancer male. TESTOSTERONE dosage: 250 MG, Q 3-4 WEEKS, INTRAMUSCULAR. Patient recovered.

Testosterone Side Effects Report #5133222-5
TESTOSTERONE problem was reported by a Health Professional from POLAND on Oct 13, 2006. Male patient was diagnosed with hypogonadism male and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: breast cancer male. TESTOSTERONE dosage: 250 MG, Q 3-4 WEEKS, INTRAMUSCULAR. Patient recovered.

Testosterone Side Effects Report #5167869-7
Pharmacist from UNITED STATES reported TESTOSTERONE problem on Dec 06, 2006. Male patient, 56 years of age, weighting 262.0 lb, was diagnosed with androgen deficiency and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: myalgia. TESTOSTERONE dosage: 25 MG Q24H. Patient was hospitalized. Patient recovered.

Testosterone Side Effects Report #5397151-4
TESTOSTERONE problem was reported by a Consumer or non-health professional from UNITED STATES on July 10, 2007. Male patient, 50 years of age, was diagnosed with osteopenia and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, dyspnoea, feeling hot, hypoaesthesia, injection site erythema, injection site pain, pharyngeal oedema, retching. TESTOSTERONE dosage: 0.75 ML, Q2 WEEKS, INTRAMUSCULAR. During the same period patient was treated with TESTOSTERONE CYPIONATE. Patient recovered.

Testosterone Side Effects Report #5398966-9
Consumer or non-health professional from UNITED KINGDOM reported TESTOSTERONE problem on July 18, 2007. Male patient, 61 years of age, was diagnosed with primary hypogonadism and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: breast cancer male, oestrogen receptor assay positive. TESTOSTERONE dosage: unknown. Patient recovered.

Testosterone Side Effects Report #5404933-9
TESTOSTERONE problem was reported by a Consumer or non-health professional from UNITED KINGDOM on July 23, 2007. Male patient, 61 years of age, weighting 205.0 lb, was diagnosed with primary hypogonadism and was treated with TESTOSTERONE. After drug was administered, patient experienced the following problems/side effects: breast cancer male. TESTOSTERONE dosage: unknown. Patient recovered.


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