Citicoline Side Effects


Common Citicoline Side Effects

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

Pneumonia (1)
Stevens-johnson Syndrome (1)
Hepatitis (1)
Cerebral Infarction (1)
Aspartate Aminotransferase Increased (1)
Cardiac Failure Acute (1)
Alanine Aminotransferase Increased (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.

Citicoline Side Effects Reported to FDA

Citicoline Side Effect Report#8239800-9
This is a report of a 44-year-old female patient (weight: NA) from Spain, suffering from the following health symptoms/conditions: NA, who was treated with Citicoline (dosage: 1 G, Uid/qd, start time:
Jun 01, 2011), combined with:
  • Dabigatran Etexilate (110 Mg, Bid)
  • Flecainide Acetate (100 Mg, Bid)
  • Vesicare (5 Mg, Uid/qd)
  • Keppra (1500 Mg, Bid)
  • Clopidogrel (75 Mg, Uid/qd)
  • Paroxetine Hydrochloride (20 Mg, Uid/qd)
  • Ranitidine (150 Mg, Uid/qd)
and developed a serious reaction and side effect(s): Hepatitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Citicoline treatment in female patients, resulting in Hepatitis side effect. The patient was hospitalized.
Citicoline Side Effect Report#8157716-3
Pneumonia, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Cardiac Failure Acute, Stevens-johnson Syndrome
This report suggests a potential Citicoline Pneumonia side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: cerebral infarction and used Citicoline (dosage: 500 Mg, 2x/day) starting
Dec 14, 2011. After starting Citicoline the patient began experiencing various side effects, including: Pneumonia, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Cardiac Failure Acute, Stevens-johnson SyndromeAdditional drugs used concurrently:
  • Radicut (30 Mg, 2x/day)
  • Cefazolin Sodium (1 G, 2x/day)
  • Plavix (75 Mg, Daily)
  • Ozagrel Sodium (80 Mg, 2x/day)
  • Lipitor (10 Mg, 1x/day)
  • Cerebid (8 Ml, 2x/day)
The patient was hospitalized. Although Citicoline demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pneumonia, may still occur.
Citicoline Side Effect Report#7552077-2
Cerebral Infarction
This Cerebral Infarction problem was reported by a consumer or non-health professional from United Kingdom. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Apr 20, 2009 this consumer started treatment with Citicoline (dosage: NA). The following drugs were being taken at the same time:
  • Glycerol 2.6%
When using Citicoline, the patient experienced the following unwanted symptoms/side effects: Cerebral InfarctionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Cerebral Infarction, may become evident only after a product is in use by the general population.

The appearance of Citicoline 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 Citicoline Side Effects for Women?

Women Side EffectsReports
Cerebral Infarction 1
Hepatitis 1

What are common Citicoline Side Effects for Men?

Men Side EffectsReports
Alanine Aminotransferase Increased 1
Aspartate Aminotransferase Increased 1
Cardiac Failure Acute 1
Pneumonia 1
Stevens-johnson Syndrome 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.

    Citicoline 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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    Citicoline Safety Alerts, Active Ingredients, Usage Information

    More About Citicoline

    Side Effects reported to FDA: 3

    Citicoline safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 3

    Latest Citicoline clinical trials