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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

CITICOLINE: 104 Adverse Event Reports & Safety Profile

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104
Total FAERS Reports
22 (21.2%)
Deaths Reported
37
Hospitalizations
104
As Primary/Secondary Suspect
4
Life-Threatening
2
Disabilities

First Report: 20100320 · Latest Report: 20250719

What Are the Most Common CITICOLINE Side Effects?

#1 Most Reported
Hypertension
40 reports (38.5%)
#2 Most Reported
Fatigue
23 reports (22.1%)
#3 Most Reported
Hyperglycaemia
22 reports (21.2%)

All CITICOLINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hypertension 40 38.5% 19 6
Fatigue 23 22.1% 0 1
Blood cholesterol increased 22 21.2% 0 0
Blood triglycerides increased 22 21.2% 0 0
Hyperglycaemia 22 21.2% 0 0
Confusional state 21 20.2% 19 7
Brain oedema 20 19.2% 20 7
Encephalopathy 20 19.2% 20 7
Pulmonary oedema 20 19.2% 20 7
Acute respiratory failure 19 18.3% 19 6
Cardiovascular insufficiency 19 18.3% 19 6
Covid-19 pneumonia 19 18.3% 19 6
Embolism 19 18.3% 19 6
Hallucination 19 18.3% 19 6
Hypoxia 19 18.3% 19 6
Off label use 19 18.3% 15 5
Tachypnoea 19 18.3% 19 6
Overdose 18 17.3% 0 1
Drug interaction 17 16.4% 0 17
Intentional product use issue 14 13.5% 14 4

Who Reports CITICOLINE Side Effects? Age & Gender Data

Gender: 35.2% female, 64.8% male. Average age: 52.4 years. Most reports from: ES. View detailed demographics →

Is CITICOLINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 3 0 0
2015 3 0 0
2016 9 0 4
2017 2 0 1
2018 9 0 0
2019 2 0 0
2020 23 19 7
2021 4 1 3
2022 2 0 1
2023 1 0 1
2024 2 0 1
2025 2 0 1

View full timeline →

What Is CITICOLINE Used For?

IndicationReports
Product used for unknown indication 42
Prophylaxis 21
Cerebral infarction 7

CITICOLINE vs Alternatives: Which Is Safer?

CITICOLINE vs CITRIC ACID CITICOLINE vs CITRIC ACID\LACTIC ACID, L-\POTASSIUM CITICOLINE vs CLADRIBINE CITICOLINE vs CLARAVIS CITICOLINE vs CLARITHROMYCIN CITICOLINE vs CLARITIN CITICOLINE vs CLARITIN CHEWABLE CITICOLINE vs CLARITIN-D-12 CITICOLINE vs CLARITIN-D-24 CITICOLINE vs CLARITIN REDITABS

Official FDA Label for CITICOLINE

Official prescribing information from the FDA-approved drug label.