OpenClaim

Pregabalin Side Effects

The most commonly reported side effects of pregabalin include pain, fatigue, and off label use, based on 268,525 FDA adverse event reports from 2004 to 2025. 8.7% of reports found the drug to be ineffective.

Pregabalin side effects

Percentages show how often each reaction appears relative to total reports for pregabalin.

1
Drug Ineffective8.7%23,281
2
Pain8.5%22,897
3
Fatigue5.0%13,482
4
Off Label Use4.9%13,150
5
Nausea4.6%12,281
6
Malaise4.3%11,435
7
Headache4.2%11,160
8
Dizziness4.1%11,116
9
Pain In Extremity3.7%9,958
10
Fall3.5%9,378
11
Somnolence3.4%9,004
12
Diarrhoea3.4%8,997
13
Dyspnoea3.3%8,801
14
Arthralgia3.2%8,500
15
Insomnia3.1%8,208

These are voluntary reports and do not establish that pregabalin caused these reactions.

Report severity

66.9%Serious179,558 reports
28.7%Hospitalizations76,949 reports
8.0%Fatal21,596 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pregabalin drug interactions

Other drugs that appear in adverse event reports alongside pregabalin. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Adalimumab3.9%10,343
2
Acetaminophen3.2%8,674
3
Gabapentin2.8%7,417
4
Methotrexate2.6%7,103
5
Oxycodone2.6%6,884
6
Etanercept2.4%6,507
7
Rituximab2.4%6,379
8
Prednisone2.4%6,376
9
Tramadol-hydrochloride2.2%5,882
10
Duloxetine-hydrochloride2.2%5,857
11
Pantoprazole-sodium1.9%5,231
12
Abatacept1.9%5,224
13
Tocilizumab1.9%5,064
14
Infliximab1.9%4,996
15
Celecoxib1.9%4,990

Taken alongside

1
Acetaminophen13.1%35,280
2
Aspirin8.3%22,262
3
Levothyroxine-sodium8.2%21,892
4
Omeprazole7.5%20,232
5
Ergocalciferol7.4%19,931
6
Duloxetine-hydrochloride6.7%17,986
7
Oxycodone6.6%17,792
8
Pantoprazole-sodium6.4%17,259
9
Atorvastatin-calcium6.4%17,152
10
Furosemide6.4%17,101
11
Metformin6.2%16,752
12
Albuterol5.6%15,027
13
Amlodipine5.4%14,474
14
Insulin5.1%13,583
15
Prednisone5.1%13,576

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports pregabalin side effects

60.0% of pregabalin adverse event reports involve female patients and 31.3% involve male patients. The largest age group is adult at 60%. These figures reflect who reports side effects, not underlying risk.

Sex

Female60.0%
Male31.3%
Unknown8.6%

Age group

< 20.2%
2–110.2%
12–170.8%
18–6460.4%
65+38.4%

What is pregabalin used for

Conditions and purposes for which patients were taking pregabalin when the adverse event was reported.

AbasiaAbdominal AdhesionsAbdominal DiscomfortAbdominal DistensionAbdominal OperationAbdominal PainAbdominal Pain LowerAbdominal Pain UpperAbnormal BehaviourAbscessAccidentAccident At WorkAccidental ExposureAccidental Exposure To ProductAccidental Exposure To Product By Child

Showing 15 of 2,916 indications

Pregabalin brand names and reporting trend

Pregabalin is sold under the brand name Lyrica.

Brand names

Lyrica90,417

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking pregabalin with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.