Common Pranactin Side Effects


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

Rash Pruritic (1)
Ventricular Extrasystoles (1)
Rash Morbilliform (1)
Palpitations (1)
Dyspepsia (1)
Heart Rate Irregular (1)
Atrial Fibrillation (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.

Pranactin Side Effects Reported to FDA


Pranactin Side Effect Report#8816598
Atrial Fibrillation, Ventricular Extrasystoles, Palpitations, Heart Rate Irregular
This is a report of a 71-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: bacterial test, who was treated with Pranactin-citric (dosage: Df Dosage Form, Oral, start time:
Jul 30, 2012), combined with:
  • Zetia (clopidogrel Sulfate)
  • Plavix (clopidogrel Sulfate)
  • Digoxin (digoxin)
  • Warfarin Sodium (warfarin Sodium)
  • Flecainide Acetate (flecainide Acetate)
  • Metoprolol (metoprolol Tartrate)
  • Crestor (rosuvastatin Calcium)
  • Ativan (lorazepam)
and developed a serious reaction and side effect(s): Atrial Fibrillation, Ventricular Extrasystoles, Palpitations, Heart Rate Irregular after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Pranactin-citric treatment in female patients, resulting in Atrial Fibrillation side effect.
Pranactin Side Effect Report#6112326-4
Rash Morbilliform, Rash Pruritic
This report suggests a potential Pranactin Citric Rash Morbilliform side effect(s) that can have serious consequences. A 46-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: helicobacter infection and used Pranactin Citric (dosage: 84 Mg Once Po) starting
Feb 10, 2009. After starting Pranactin Citric the patient began experiencing various side effects, including: Rash Morbilliform, Rash PruriticAdditional drugs used concurrently: NA. Although Pranactin Citric demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash Morbilliform, may still occur.
Pranactin Side Effect Report#4990742-1
Dyspepsia
This Dyspepsia problem was reported by a consumer or non-health professional from United States. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: helicobacter infection. On
Apr 12, 2006 this consumer started treatment with Pranactin-citric, (dosage: One Pouch Per Test). The following drugs were being taken at the same time:
  • ...
  • Tagamet
  • Zelnorm
  • Hrt
  • Vitamin B Complex Cap
  • Lactose Tablets
When using Pranactin-citric,, the patient experienced the following unwanted symptoms/side effects: DyspepsiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyspepsia, may become evident only after a product is in use by the general population.



The appearance of Pranactin 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 Pranactin Side Effects for Women?

Women Side Effects Reports
Atrial Fibrillation 1
Dyspepsia 1
Heart Rate Irregular 1
Palpitations 1
Ventricular Extrasystoles 1

What are common Pranactin Side Effects for Men?

Men Side Effects Reports
Rash Morbilliform 1
Rash Pruritic 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.

    Pranactin 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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    Pranactin Safety Alerts, Active Ingredients, Usage Information

    NDC 59148-023
    Type HUMAN PRESCRIPTION DRUG
    Proprietary Name Pranactin-Citric
    Name UREA C-13
    Dosage Form POWDER, FOR SOLUTION
    Route ORAL
    On market since 20010510
    Labeler Otsuka America Pharmaceutical
    Active Ingredient(s) UREA C-13
    Strength(s) 75
    Unit(s) mg/3000mg
    Pharma Class Carbon Radioisotopes [Chemical/Ingredient],Helicobacter pylori Diagnostic [EPC],Radioactive Tracers

    More About Pranactin

    Side Effects reported to FDA: 3

    Pranactin safety alerts: No

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