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.

Prostate Side Effects Reported to FDA

Prostate Side Effect Report#7940278-0
No Adverse Event
This is a report of a 77-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Prostate Health Essentials (dosage: NA, start time:
Sep 18, 2011), combined with:
  • Aleve (caplet) (2 Df, Bid)
and developed a serious reaction and side effect(s): No Adverse Event after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prostate Health Essentials treatment in male patients, resulting in No Adverse Event side effect.
Prostate Side Effect Report#7262002-X
Injection Site Pain
This report suggests a potential Prostate Support 300 Injection Site Pain side effect(s) that can have serious consequences. A 77-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: prostatic disorder,vitamin supplementation,mineral supplementation,rheumatoid arthritis and used Prostate Support 300 (dosage: 1-3 Tabs Daily) starting NS. After starting Prostate Support 300 the patient began experiencing various side effects, including: Injection Site PainAdditional drugs used concurrently:
  • Folic Acid
  • Calcium
  • Humira
  • Methotrexate
  • Multi-vitamin
Although Prostate Support 300 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Injection Site Pain, may still occur.

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.

What are common Prostate Side Effects for Women?

Women Side EffectsReports

What are common Prostate Side Effects for Men?

Men Side EffectsReports
Injection Site Pain 1
No Adverse Event 1

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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 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.

    Discuss Prostate Side Effects

    Did You Have a Prostate Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor

    How Effective is Prostate for You?

    Exceeded Expectations
    Somewhat Effective
    Not Effective

    Prostate Safety Alerts, Active Ingredients, Usage Information

    Proprietary NameGUNA-PROSTATE
    Dosage FormSOLUTION/ DROPS
    On market since20080416
    LabelerGuna spa
    Strength(s)4; 30; 6; 6; 3; 30; 30; 30; 30; 4; 4; 4; 3; 30; 200; 30; 4; 3
    Unit(s)[hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30
    Pharma Class

    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:
    • 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