Pregabalin Side Effects: Common, Serious & FDA Warnings
Based on 267,000+ FDA adverse event reports, the most-reported pregabalin reactions include pain, fatigue, and dizziness. FDA reports 1 active Class II recall of pregabalin, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.
Common Side Effects of Pregabalin
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for pregabalin. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Pain | 26,107 | 9.8% |
| Fatigue | 15,360 | 5.7% |
| Dizziness | 14,674 | 5.5% |
| Nausea | 14,270 | 5.3% |
| Headache | 12,871 | 4.8% |
| Malaise | 12,734 | 4.8% |
| Somnolence | 11,696 | 4.4% |
| Weight Increased | 11,502 | 4.3% |
| Pain In Extremity | 11,283 | 4.2% |
| Dyspnoea | 10,279 | 3.8% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
From the FDA-approved label, Section 5.1: Angioedema
There have been postmarketing reports of angioedema in patients during initial and chronic treatment with pregabalin. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Discontinue pregabalin immediately in patients with these symptoms. Exercise caution when prescribing pregabalin to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.
From the FDA-approved label, Section 5.4: Respiratory Depression
There is evidence from case reports, human studies, and animal studies associating pregabalin with serious, life-threatening, or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe pregabalin with another CNS depressant, particularly an opioid, or to prescribe pregabalin to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating pregabalin at a low dose.Show full Section 5.4
The management of respiratory depression may include close observation, supportive measures, and reduction or withdrawal of CNS depressants (including pregabalin). There is more limited evidence from case reports, animal studies, and human studies associating pregabalin with serious respiratory depression, without co-administered CNS depressants or without underlying respiratory impairment.
Pregabalin Recalls
FDA enforcement actions matched to pregabalin via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2024-06-12 | Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg. Rising Pharma Holding, Inc. | Class III | N/A | Ongoing |
Show 4 closed recalls (2016 to 2022)
Includes resolved and terminated recalls matched to pregabalin. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2022-01-12 | Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient. SUN PHARMACEUTICAL INDUSTRIES INC | Class II | 696 Bottles | Terminated |
| 2021-06-02 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. Cardinal Health Inc. | Class II | 6 CONTAINERS | Terminated |
| 2016-02-10 | FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. Pfizer Inc. | Class II | 30,672 bottles | Terminated |
| 2016-02-10 | FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules. Pfizer Inc. | Class II | 116,400 bottles | Terminated |
Pregabalin Shortages
FDA-listed shortages of pregabalin products. Strength and dosage-form level detail.
Is Pregabalin Safe?
Pregabalin is FDA-approved and the label does not carry a boxed warning. The label's Warnings and Precautions section covers angioedema (Section 5.1), hypersensitivity (Section 5.2), suicidal behavior and ideation (Section 5.3), respiratory depression (Section 5.4), dizziness and somnolence (Section 5.5), increased risk of adverse reactions with abrupt or rapid (Section 5.6), peripheral edema (Section 5.7), weight gain (Section 5.8), tumorigenic (Section 5.9), ophthalmological (Section 5.10), creatine kinase elevations (Section 5.11), decreased platelet count (Section 5.12), pr interval prolongation (Section 5.13).
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Pregabalin is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (1 ) Postherpetic neuralgia (PHN) (1) Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older ( 1) Fibromyalgia ( 1) Neuropathic pain associated with spinal cord injury (1 )
Frequently Asked Questions
What are the most-reported side effects of pregabalin?
Is pregabalin the same as Lyrica Cr?
Has pregabalin been recalled?
What are pregabalin's current ongoing recalls about?
What do FDA recall classes mean?
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.