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Prostate Side Effects

Common Prostate Side Effects

The most commonly reported Prostate side effects (click to view or check a box to report):

No Adverse Event (1)
Injection Site Pain (1)


If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Prostate Side Effects Reported to FDA

The following Prostate reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Prostate on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
No Adverse Event
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
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 and. Prostate Support 300 dosage: 1-3 Tabs Daily.
Multiple prescriptions taken:
  • Folic Acid
  • Calcium
  • Humira
  • Methotrexate
  • Multi-vitamin




PillPack: Pharmacy Simplified

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Prostate Side Effects



    Did You Have a Prostate Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Prostate for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative PROSTATE Names:ALDESLEUK BARYTA CA CHIMAPHIL CLEMATIS THYROIDIN

    Active Ingredient: ALDESLEUK ARCTIUM L BARIUM CA CHIMAPHIL CLEMATIS

    More About Prostate

    Side Effects reported to FDA: 2

    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: www.fda.gov/MedWatch/report.htm
    • 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]

    Latest Prostate clinical trials