FLUNARIZINE: 337 Adverse Event Reports & Safety Profile
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337
Total FAERS Reports
1 (0.3%)
Deaths Reported
74
Hospitalizations
337
As Primary/Secondary Suspect
13
Life-Threatening
32
Disabilities
First Report: 200902 · Latest Report: 20250604
What Are the Most Common FLUNARIZINE Side Effects?
#1 Most Reported
Off label use
115 reports (34.1%)
#2 Most Reported
Drug ineffective
108 reports (32.0%)
#3 Most Reported
Product use in unapproved indication
89 reports (26.4%)
All FLUNARIZINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 115 | 34.1% | 1 | 11 |
| Drug ineffective | 108 | 32.1% | 0 | 29 |
| Product use in unapproved indication | 89 | 26.4% | 0 | 10 |
| Insomnia | 50 | 14.8% | 0 | 2 |
| Treatment failure | 49 | 14.5% | 0 | 0 |
| Drug intolerance | 47 | 14.0% | 0 | 1 |
| Drug abuse | 43 | 12.8% | 0 | 4 |
| Paraesthesia | 42 | 12.5% | 0 | 2 |
| Migraine | 37 | 11.0% | 0 | 1 |
| Headache | 31 | 9.2% | 0 | 8 |
| Therapy partial responder | 31 | 9.2% | 0 | 0 |
| Drug ineffective for unapproved indication | 30 | 8.9% | 0 | 4 |
| Serotonin syndrome | 27 | 8.0% | 0 | 6 |
| Product use issue | 24 | 7.1% | 0 | 1 |
| Therapeutic product effect incomplete | 24 | 7.1% | 0 | 18 |
| Weight decreased | 23 | 6.8% | 0 | 22 |
| Somnolence | 22 | 6.5% | 0 | 19 |
| Weight increased | 22 | 6.5% | 0 | 1 |
| Withdrawal syndrome | 22 | 6.5% | 0 | 22 |
| Drug eruption | 21 | 6.2% | 0 | 20 |
Who Reports FLUNARIZINE Side Effects? Age & Gender Data
Gender: 62.5% female, 37.5% male. Average age: 45.6 years. Most reports from: ES. View detailed demographics →
Is FLUNARIZINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2009 | 29 | 0 | 0 |
| 2011 | 2 | 1 | 0 |
| 2014 | 4 | 0 | 1 |
| 2015 | 5 | 0 | 3 |
| 2016 | 2 | 0 | 2 |
| 2017 | 4 | 0 | 0 |
| 2018 | 26 | 0 | 8 |
| 2019 | 4 | 0 | 1 |
| 2020 | 4 | 0 | 1 |
| 2021 | 4 | 0 | 0 |
| 2022 | 3 | 0 | 2 |
| 2023 | 4 | 0 | 4 |
| 2024 | 1 | 0 | 0 |
| 2025 | 2 | 0 | 0 |
What Is FLUNARIZINE Used For?
| Indication | Reports |
|---|---|
| Migraine | 166 |
| Product used for unknown indication | 43 |
| Migraine prophylaxis | 40 |
| New daily persistent headache | 22 |
| Prophylaxis | 9 |
| Headache | 7 |
| Post-traumatic headache | 6 |
| Migraine with aura | 5 |
FLUNARIZINE vs Alternatives: Which Is Safer?
FLUNARIZINE vs FLUNISOLIDE
FLUNARIZINE vs FLUNITRAZEPAM
FLUNARIZINE vs FLUOCINOLONE
FLUNARIZINE vs FLUOCINOLONE ACETONIDE
FLUNARIZINE vs FLUOCINOLONE ACETONIDE\HYDROQUINONE\TRETINOIN
FLUNARIZINE vs FLUOCINONIDE
FLUNARIZINE vs FLUORESCEIN
FLUNARIZINE vs FLUOROMETHOLONE
FLUNARIZINE vs FLUOROURACIL
FLUNARIZINE vs FLUOROURACIL\IRINOTECAN\LEUCOVORIN
Official FDA Label for FLUNARIZINE
Official prescribing information from the FDA-approved drug label.