Question explored with the scientific record
Conversation so far
- 1 Is pregabalin safe?
- 2 What are the key risks or side effects of pregabalin for adults?
Answered on this page ↓
What are the key risks or side effects of pregabalin for adults?
The key risks are central nervous system sedation, dose-dependent dizziness and somnolence, weight gain, and a withdrawal syndrome that can be severe enough to require hospital management.
The largest pooled safety analysis, sponsored by Pfizer and covering 4,884 pregabalin users across 31 trials, found that about 24 in 100 people reported dizziness and about 15 in 100 reported somnolence, both far above placebo rates [2]. These effects typically start within the first week or two and often resolve over the same period, but they are common enough to affect daily function [2]. A smaller comparative trial found that pregabalin caused sedation in about 25 in 100 patients, significantly more than the 9 in 100 seen with gabapentin [1].
Weight gain is another well-documented risk. Across the pooled trials, about 6 in 100 pregabalin users gained weight, compared to about 1 in 100 on placebo [2]. In an epilepsy add-on study, nearly 25 in 100 pregabalin patients had significant weight gain, versus about 4 in 100 on placebo [6]. Peripheral edema (swelling in the limbs) affected about 9 in 100 users, more than double the placebo rate [2].
The withdrawal risk is serious. Pregabalin is a controlled substance in the UK and elsewhere because of its abuse potential and the severity of discontinuation symptoms [4]. A 2026 hospital guideline specifically addresses managing pregabalin withdrawal, confirming that it can be severe enough to require structured medical oversight [3]. In overdose, the drug is relatively mild when taken alone, but becomes dangerous when combined with opioids or benzodiazepines, which happened in about 79 of every 100 poisoning cases in one Australian series [5].
| Adverse event | Pregabalin rate (per 100) | Placebo rate (per 100) | Risk difference |
|---|---|---|---|
| Dizziness | 24.3 | 7.3 | +17.0 |
| Somnolence | 15.1 | 4.6 | +10.5 |
| Peripheral edema | 8.6 | 3.6 | +5.0 |
| Weight increase | 6.2 | 1.3 | +4.9 |
| Dry mouth | 5.0 | 2.0 | +3.0 |
| Constipation | 4.8 | 2.4 | +2.4 |
| Blurred vision | 3.6 | 1.3 | +2.3 |
| Balance disorder | 2.2 | 0.3 | +1.9 |
| Euphoric mood | 1.3 | 0.0 | +1.3 |
My call: pregabalin carries a clear and dose-dependent set of risks dominated by CNS sedation, weight gain, and withdrawal liability. The evidence is strong on the rates of these common adverse events, but the long-term safety data beyond one year is thin in these records. Confidence: high for the common side effects listed; moderate for the full picture of rare or very-long-term harms.
Sources used 6
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Comparative study of safety and efficacy of pregabalin and gabapentin in management of neuropathic pain associated with chronic lumbar radiculopathy
Pregabalin and gabapentin both significantly reduced NPRS pain scores in chronic lumbar radiculopathy at 12 weeks with no significant intergroup difference, but gabapentin had a significantly lower incidence of sedation and was considered better tolerated.
DOI: 10.18203/2319-2003.ijbcp20194788 -
A Comprehensive Drug Safety Evaluation of Pregabalin in Peripheral Neuropathic Pain
This Pfizer-sponsored analysis pooled patient-level data from 31 randomized trials of pregabalin in peripheral neuropathic pain to characterize the incidence and timing of adverse events, compare across doses and disease conditions, and advocate careful dose titration to maximiz…
DOI: 10.1111/papr.12146 -
Improving Outcomes Best Practices for Pregabalin Withdrawal Management in Hospitals
A computational DRD2 docking pipeline recovered known antipsychotics, identified FDA-approved repurposing candidates such as dolasetron and trazodone, and generated optimized ligand variants with improved predicted binding affinities.
DOI: 10.1192/bjo.2026.11952 -
Gabapentinoids: pharmacokinetics, pharmacodynamics and considerations for clinical practice
This article reviews the pharmacokinetics, pharmacodynamics, clinical use, safety, and regulatory considerations of gabapentin and pregabalin in neuropathic and non-neuropathic pain, highlighting their mechanisms, efficacy, risks, and perioperative use.
DOI: 10.1177/2049463720912496 -
Pregabalin poisoning and rising recreational use: a retrospective observational series
A five-year retrospective observational study of pregabalin poisoning at two Australian toxicology units (2014–2019) describing patient demographics, dosing, co-ingestants, clinical effects (coma, seizures, hypotension), outcomes, and a rising prevalence of recreational use, con…
DOI: 10.1111/bcp.14348 -
Pregabalin add‐on therapy using a flexible, optimized dose schedule in refractory partial epilepsies: A double‐blind, randomized, placebo‐controlled, multicenter trial
This study evaluates the efficacy and safety of pregabalin as an add-on therapy using a flexible dosing schedule in Korean patients with refractory partial-onset seizures, demonstrating significant seizure frequency reduction compared to placebo.
DOI: 10.1111/j.1528-1167.2008.01954.x