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Fenac Side Effects

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Common Fenac Side Effects


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

Retinal Detachment (1)
Retinal Tear (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.

Fenac Side Effects Reported to FDA


Fenac Side Effect Report#4853136-5
Retinal Detachment, Retinal Tear
This is a report of a 71-year-old male patient (weight: NA) from Australia, suffering from the following health symptoms/conditions: osteoarthritis, who was treated with Fenac (diclofenac Sodium) (dosage: 25,000 Mg (25 Mg, 1 In 1 D) Oral, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Retinal Detachment, Retinal Tear after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fenac (diclofenac Sodium) treatment in male patients, resulting in Retinal Detachment side effect.



The appearance of Fenac 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 Fenac Side Effects for Women?

Women Side EffectsReports

What are common Fenac Side Effects for Men?

Men Side EffectsReports
Retinal Detachment 1
Retinal Tear 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.

    Fenac 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.

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    Fenac Safety Alerts, Active Ingredients, Usage Information

    NDC0093-0948
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDiclofenac Potassium
    NameDiclofenac Potassium
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since19980811
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)DICLOFENAC POTASSIUM
    Strength(s)50
    Unit(s)mg/1
    Pharma ClassCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammato

    More About Fenac

    Side Effects reported to FDA: 1

    Fenac safety alerts: 2009

    Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes

    Audience: Rheumatological healthcare professionals, pharmacists

    [Posted 12/04/2009] Endo, Novartis and FDA notified healthcare professionals of revisions to the Hepatic Effects section of the prescribing information to add new warnings and precautions about the potential for elevation in liver function tests during treatment with all products containing diclofenac sodium. 

    In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month but can occur at any time during treatment with diclofenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of  these reported cases resulted in fatalities or liver transplantation. 

    Physicians should measure transaminases periodically in patients receiving long-term therapy with diclofenac. The optimum times for making the first and subsequent transaminase measurement are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with diclofenac.

    [12/04/2009 - Dear Healthcare Professional Letter - Endo, Novartis]
    [Sept 2009 - Prescribing Information - Endo]

    Latest Fenac clinical trials