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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.

Restless legs syndrome: Which Medications Cause It? (12,649 Reports Across 547 Drugs)

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Restless legs syndrome has been reported as an adverse event with 547 different drugs in the FDA's FAERS database, with 12,649 total reports. 179 of these reports resulted in death.The drugs most commonly associated with Restless legs syndrome are SODIUM OXYBATE, QUETIAPINE, and MIRTAZAPINE.

12,649
Total Reports
547
Drugs Involved
179
Deaths
2,317
Hospitalizations
54.7 yrs
Average Patient Age
68.6% / 31.4%
Female / Male

Which Drugs Cause Restless legs syndrome Most Often?

Drug Reports % of Drug Reports Deaths Hosp. Life-Threat.
SODIUM OXYBATE 575 0.9% 2 52 1
QUETIAPINE 514 0.7% 2 140 51
MIRTAZAPINE 342 1.2% 2 91 28
PREGABALIN 329 0.3% 2 51 7
PRAMIPEXOLE 326 5.4% 3 63 3
ARIPIPRAZOLE 308 0.5% 0 52 8
ADALIMUMAB 280 0.1% 1 88 5
GABAPENTIN 263 0.4% 1 51 2
SERTRALINE 255 0.4% 0 50 15
ROTIGOTINE 254 3.2% 2 32 2
ENZALUTAMIDE 223 0.5% 9 28 2
BUROSUMAB-TWZA 217 4.2% 1 4 0
VENLAFAXINE 207 0.4% 3 50 2
DULOXETINE 202 0.4% 1 16 1
CARBIDOPA\LEVODOPA 198 0.3% 9 78 2
OXYCODONE 195 0.1% 8 51 5
OMEPRAZOLE 187 0.2% 2 55 47
TREPROSTINIL 177 0.2% 6 52 0
CLONAZEPAM 174 0.4% 1 62 35
LENALIDOMIDE 172 0.1% 2 15 4

View all 547 drugs →

Top 3 Drugs Associated With Restless legs syndrome

575 reports
514 reports
342 reports

Related Side Effects

Drug ineffective (1,049,718) Off label use (762,782) Death (660,423) Fatigue (599,248) Nausea (562,301) Diarrhoea (491,550) Pain (471,975) Headache (460,069) Dyspnoea (409,496) Dizziness (352,922)