What the label lists and what reports show
Pregabalin side effects
Pregabalin's FDA label: “Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention).” FAERS holds 270,624 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (26,330 reports).
- Generic listed
- DEA Schedule V
Check it at the source: the pregabalin FDA label on DailyMed (effective April 15, 2025, Viatris Specialty LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of LYRICA?LYRICA may cause serious side effects, including: • See “What is the most important information I should know about LYRICA?" • Muscle problems, muscle pain, soreness, or weakness. If you have these symptoms, especially if you feel sick and have a fever, tell your healthcare provider right away. • Problems with your eyesight, including blurry vision. Call your healthcare provider if you have any changes in your eyesight. • Weight gain. If you have diabetes, weight gain may affect the management of your diabetes. Weight gain can also be a serious problem for people with heart problems. • Feeling “high”. The most common side effects of LYRICA in adults are: • dizziness • blurry vision • dry mouth • weight gain • sleepiness • trouble concentrating • swelling of hands and feet The most common side effects of LYRICA in children are weight gain, increase in appetite, and sleepiness. […]
Source: FDA drug label, NDA021446 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2025 (SPL set d4734e7d-5079-455e-8ff5-8f4539c998a9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention).
Table 4. Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain Associated with Diabetic Peripheral Neuropathy
| Body system Preferred term | 75 mg/day [N=77] % | 150 mg/day [N=212] % | 300 mg/day [N=321] % | 600 mg/day [N=369] % | All PGB PGB: pregabalin [N=979] % | Placebo [N=459] % |
|---|---|---|---|---|---|---|
| Asthenia | 4 | 2 | 4 | 7 | 5 | 2 |
| Accidental injury | 5 | 2 | 2 | 6 | 4 | 3 |
| Back pain | 0 | 2 | 1 | 2 | 2 | 0 |
| Chest pain | 4 | 1 | 1 | 2 | 2 | 1 |
| Face edema | 0 | 1 | 1 | 2 | 1 | 0 |
| Dry mouth | 3 | 2 | 5 | 7 | 5 | 1 |
| Constipation | 0 | 2 | 4 | 6 | 4 | 2 |
| Flatulence | 3 | 0 | 2 | 3 | 2 | 1 |
| Peripheral edema | 4 | 6 | 9 | 12 | 9 | 2 |
| Weight gain | 0 | 4 | 4 | 6 | 4 | 0 |
| Edema | 0 | 2 | 4 | 2 | 2 | 0 |
| Hypoglycemia | 1 | 3 | 2 | 1 | 2 | 1 |
| Dizziness | 8 | 9 | 23 | 29 | 21 | 5 |
| Somnolence | 4 | 6 | 13 | 16 | 12 | 3 |
| Neuropathy | 9 | 2 | 2 | 5 | 4 | 3 |
| Ataxia | 6 | 1 | 2 | 4 | 3 | 1 |
| Vertigo | 1 | 2 | 2 | 4 | 3 | 1 |
| Confusion | 0 | 1 | 2 | 3 | 2 | 1 |
| Euphoria | 0 | 0 | 3 | 2 | 2 | 0 |
| Incoordination | 1 | 0 | 2 | 2 | 2 | 0 |
| Thinking abnormal Thinking abnormal primarily consists of events related to difficulty… | 1 | 0 | 1 | 3 | 2 | 0 |
| Tremor | 1 | 1 | 1 | 2 | 1 | 0 |
| Abnormal gait | 1 | 0 | 1 | 3 | 1 | 0 |
| Amnesia | 3 | 1 | 0 | 2 | 1 | 0 |
| Nervousness | 0 | 1 | 1 | 1 | 1 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described elsewhere in the labeling: • Angioedema [see Warnings and Precautions (5.1) ] • Hypersensitivity [see Warnings and Precautions (5.2) ] • Suicidal Behavior and Ideation [see Warnings and Precautions (5.3) ] • Increased Risk of Adverse Reactions with Abrupt or Rapid Discontinuation [see Warnings and Precautions (5.4) ] • Respiratory Depression [see Warnings and Precautions (5.5) ] • Dizziness and Somnolence [see Warnings and Precautions (5.6) ] • Peripheral Edema [see Warnings and Precautions (5.7) ] • Weight Gain [see Warnings and Precautions (5.8) ] • Tumorigenic Potential [see Warnings and Precautions (5.9) ] • Ophthalmological Effects [see Warnings and Precautions (5.10) ] • Creatine Kinase Elevations [see Warnings and Precautions (5.11) ] • Decreased Platelet Count [see Warnings and Precautions (5.12) ] • PR Interval Prolongation [see Warnings and Precautions (5.13) ] Most common adverse reactions (greater than or equal to 5% and twice placebo) in adults are dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and thinking abnormal (primarily difficulty with concentration/attention). ( 6.1 ) Most common adverse reactions (greater than or equal to 5% and twice placebo) in pediatric patients for the treatment of partial‑onset seizures are increased weight and increased appetite.
Source: FDA drug label, NDA021446 (Upjohn), as published by Viatris Specialty LLC, effective April 15, 2025 (SPL set d4734e7d-5079-455e-8ff5-8f4539c998a9), via openFDA; the full label on DailyMed
What do FAERS reports show?
270,624 reports list pregabalin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 22,084 are coded as a death and 77,266 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 16 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Pregabalin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions