Common Folbic Side Effects

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

Pruritus (1)
Lip Swelling (1)
Hypersensitivity (1)
Tongue Discolouration (1)
Rash (1)
Rash Erythematous (1)
Therapeutic Response Decreased (1)
Tardive Dyskinesia (1)
Sjogren's Syndrome (1)
Rash Papular (1)
Dysphagia (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.

Folbic Side Effects Reported to FDA

Folbic Side Effect Report#8433094-7
Tardive Dyskinesia
This is a report of a 51-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Folbic Vitamin B Complex (dosage: NA, start time: NS), combined with:
  • Aspirin
  • Seroquel
  • Ensure Clear
  • Calcium Carbonate
  • One A Day
and developed a serious reaction and side effect(s): Tardive Dyskinesia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Folbic Vitamin B Complex treatment in female patients, resulting in Tardive Dyskinesia side effect.
Folbic Side Effect Report#8132728-4
Sjogren's Syndrome
This report suggests a potential Folbic Sjogren's Syndrome side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Folbic (dosage: Unk) starting
Jan 01, 2009. After starting Folbic the patient began experiencing various side effects, including: Sjogren's SyndromeAdditional drugs used concurrently:
  • Temazepam (Unk)
  • Potassium (Unk)
  • Lyrica (75 Mg, 2x/day)
  • Doxepin (Unk)
Although Folbic demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Sjogren's Syndrome, may still occur.
Folbic Side Effect Report#7803508-1
Lip Swelling, Pruritus, Tongue Discolouration, Rash, Dysphagia, Rash Papular, Therapeutic Response Decreased, Hypersensitivity, Rash Erythematous
This Lip Swelling problem was reported by a physician from United States. A 85-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jul 19, 2011 this consumer started treatment with Folbic (dosage: NA). The following drugs were being taken at the same time:
  • Procrit (Unk)
  • Aranesp
When using Folbic, the patient experienced the following unwanted symptoms/side effects: Lip Swelling, Pruritus, Tongue Discolouration, Rash, Dysphagia, Rash Papular, Therapeutic Response Decreased, Hypersensitivity, Rash ErythematousAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Lip Swelling, may become evident only after a product is in use by the general population.

The appearance of Folbic 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 Folbic Side Effects for Women?

Women Side Effects Reports
Sjogren's Syndrome 1
Tardive Dyskinesia 1

What are common Folbic Side Effects for Men?

Men Side Effects Reports
Dysphagia 1
Hypersensitivity 1
Lip Swelling 1
Pruritus 1
Rash 1
Rash Erythematous 1
Rash Papular 1
Therapeutic Response Decreased 1
Tongue Discolouration 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.

    Folbic 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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    Folbic Safety Alerts, Active Ingredients, Usage Information

    NDC 0615-7575
    Proprietary Name Folbic
    Name Pyridoxine and Cyanocobalamin and Folic Acid
    Dosage Form TABLET
    Route ORAL
    On market since 20100219
    Labeler NCS HealthCare of KY, Inc dba Vangard Labs
    Strength(s) 2; 2.5; 25
    Unit(s) mg/1; mg/1; mg/1
    Pharma Class Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]

    More About Folbic

    Side Effects reported to FDA: 3

    Folbic safety alerts: No

    Latest Folbic clinical trials

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