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Prostate Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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No Adverse Event (7940278-0)
on Sep 21, 2011 Male from UNITED STATES , 77 years of age, weighting 174.2 lb, was treated with Prostate Health Essentials. Directly after, patient experienced the unwanted or unexpected Prostate side effects: no adverse event. Prostate Health Essentials dosage: N/A.
Associated medications used:
  • Aleve (caplet) (2 Df, Bid)

Injection Site Pain (7262002-X)
Patient was taking Prostate Support 300. Patient felt the following Prostate side effects: injection site pain on Nov 04, 2010 from UNITED STATES Additional patient health information: Male , 77 years of age, was diagnosed with
  • prostatic disorder
  • vitamin supplementation
  • mineral supplementation
  • rheumatoid arthritis
and. Prostate Support 300 dosage: 1-3 Tabs Daily.
Multiple prescriptions taken:
  • Folic Acid
  • Calcium
  • Humira
  • Methotrexate
  • Multi-vitamin

Prostate Health Episodes

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Prostate Information



More About Prostate

Side Effects reported to FDA: 2. View Prostate Adverse Reports

Prostate safety alerts: 2011 2010

5-alpha reductase inhibitors (5-ARIs): Label Change - Increased Risk of Prostate Cancer

Drugs in the 5-ARI class include finasteride and dutasteride. These drugs are marketed under the brand-names Proscar, Propecia, Avodart, and Jalyn


[Posted 06/09/2011]

AUDIENCE: Urology, Family Medicine, Internal Medicine

ISSUE: FDA notified healthcare professionals that the Warnings and Precautions section of the labels for the 5-alpha reductase inhibitor (5-ARI) class of drugs has been revised to include new safety information about the increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).

BACKGROUND: The new safety information is based on FDA’s review of two large, randomized controlled trials––the Prostate Cancer Prevention Trial (PCPT) and the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial. Proscar, Avodart, and Jalyn are approved to improve symptoms of an enlarged prostate gland (benign prostatic hyperplasia or BPH). Proscar and Avodart are also approved to reduce the risk of urinary retention or surgery related to an enlarged prostate.Propecia is approved to treat male pattern hair loss.

RECOMMENDATION: Prior to initiating therapy with 5-ARIs, perform appropriate evaluation to rule out other urological conditions, including prostate cancer, that might mimic benign prostatic hyperplasia (BPH). See Drug Safety Communication for a Data Summary and additional information.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[06/09/2011 - Drug Safety Communication - FDA]

[06/09/2011 - Q and A's - FDA]

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