| Most Lyrica side effects appear soon after starting the medication or after dose increases. |
Cannot Determine |
Provided excerpts state certain adverse reactions occur and are dose-related, but do not specify “most appear soon after starting or after dose increases.” |
Informational |
| Lyrica side effects commonly appear within the first days to weeks. |
Cannot Determine |
No label timing window (days–weeks) is included in the provided excerpts. |
Informational |
| Dizziness is a commonly reported early side effect of Lyrica. |
Partially Supported |
Supported that dizziness may occur (Sections 5.5 and 6.1); “early” timing is not specified in the excerpts. |
Informational |
| Drowsiness is a commonly reported early side effect of Lyrica. |
Partially Supported |
Label supports somnolence/sleepiness (Sections 5.5 and 6.1); “early” timing is not specified. |
Informational |
| Early Lyrica side effects often improve as the body adjusts. |
Cannot Determine |
No excerpted language on symptom improvement over time. |
Informational |
| Early Lyrica side effects often improve within a few weeks. |
Cannot Determine |
No excerpted language specifying improvement within “a few weeks.” |
Informational |
| Some Lyrica side effects may persist longer. |
Cannot Determine |
Provided excerpts do not discuss duration/persistence timelines. |
Informational |
| Persisting longer of Lyrica side effects may occur especially if the dose stays high. |
Cannot Determine |
Label excerpt indicates dose-dependent adverse reactions (e.g., Sections 2.x discussion and 6.1), but not that persistence occurs “especially” with high dose. |
Informational |
| Persisting longer of Lyrica side effects may occur especially in people sensitive to pregabalin. |
Cannot Determine |
No labeling excerpt provided addresses “sensitivity” as a determinant of longer persistence. |
Informational |
| Serious reactions to Lyrica can include trouble breathing. |
Partially Supported |
Label excerpt includes dyspnea/wheezing as hypersensitivity symptoms (5.2) and respiratory compromise with life-threatening angioedema (5.1) and respiratory depression (5.4); “trouble breathing” is consistent but not explicitly phrased this way across all serious reactions. |
Moderate |
| Serious reactions to Lyrica can include facial or throat swelling. |
Supported |
Angioedema symptoms include swelling of the face and neck/throat and larynx (Section 5.1). |
High |
| Serious reactions to Lyrica can include widespread rash with fever. |
Cannot Determine |
Label excerpt for hypersensitivity lists rash/hives/blisters and dyspnea/wheezing, but “widespread rash with fever” is not included in the provided text. |
Moderate |
| Serious reactions to Lyrica can include fainting. |
Cannot Determine |
No fainting/syncope symptom is included in provided warnings/adverse reaction excerpts. |
Moderate |
| Serious reactions to Lyrica can include severe allergic symptoms. |
Partially Supported |
Label supports hypersensitivity/angioedema requiring immediate discontinuation (Sections 5.1–5.2) but does not use the phrase “severe allergic symptoms” (general agreement). |
Informational |
| Urgent care is recommended if severe confusion occurs during Lyrica use. |
Cannot Determine |
No excerpted guidance about confusion/urgent care criteria is provided. |
Moderate |
| Urgent care is recommended if worsening coordination occurs during Lyrica use. |
Cannot Determine |
No excerpted guidance about coordination and urgency/level of care. |
Moderate |
| Urgent care is recommended if signs of overdose occur. |
Cannot Determine |
Overdose management instructions/urgency level are not provided in the supplied excerpts. |
Moderate |
| Lyrica side effects can develop later even if a person tolerates the medication at first. |
Cannot Determine |
Label excerpt does not describe timing of onset relative to initial tolerance. |
Informational |
| Lyrica can cause weight gain over longer periods. |
Partially Supported |
Label supports that weight gain may occur (Section 5.8), but provided text does not specify “over longer periods.” |
Informational |
| Lyrica can cause swelling (edema) over longer periods. |
Partially Supported |
Label states LYRICA may cause peripheral edema (Section 5.7), but does not specify “over longer periods.” |
Informational |
| Lyrica can cause changes in mood or behavior over longer periods. |
Cannot Determine |
Provided adverse reaction excerpt mentions “thinking abnormal” (6.1), but no mood/behavior changes over time are included in the supplied sections. |
Moderate |
| The risk of side effects can increase with ongoing dosing of Lyrica. |
Cannot Determine |
Label notes dose-related adverse reactions and dose-dependent issues (e.g., 2.x discussion), but does not explicitly say risk increases with ongoing dosing over time. |
Informational |
| The timing of Lyrica side effects varies by dose. |
Cannot Determine |
Label excerpts support dose-dependent adverse reactions (e.g., 2.x and 6.1) but do not state that timing varies by dose. |
Informational |
| The timing of Lyrica side effects varies by how quickly the dose is increased. |
Cannot Determine |
Label excerpt says the effect of dose escalation rate on tolerability has not been formally studied (Section 2.4), which does not support this timing claim. |
Informational |
| The timing of Lyrica side effects varies by individual sensitivity. |
Cannot Determine |
Label excerpts mention tolerability and dose-dependent adverse reactions, but do not specify “individual sensitivity” as a determinant of side-effect timing. |
Informational |
| The timing of Lyrica side effects varies by age. |
Cannot Determine |
No age-based timing statement is included in provided excerpts. |
Informational |
| The timing of Lyrica side effects varies by other medications, especially other sedatives or opioids. |
Cannot Determine |
Label supports additive effects on cognitive/gross motor functioning with oxycodone/lorazepam/ethanol (Section 7) and serious respiratory depression when co-administered with CNS depressants/opioids (5.4), but timing variability is not specified. |
Moderate |
| The timing of Lyrica side effects varies by kidney function. |
Cannot Determine |
Label requires dose adjustment in reduced renal function (2.1, 2.7) due to renal excretion and dose-dependent adverse reactions; however, side-effect timing variation by kidney function is not stated. |
Informational |
| The timing of Lyrica side effects varies by overall health. |
Cannot Determine |
No label excerpt specifies timing variability by “overall health.” |
Informational |
| Clinicians may reduce the dose or slow titration of Lyrica rather than stopping abruptly when side effects are bothersome. |
Partially Supported |
Label supports tapering gradually rather than abrupt discontinuation (2.1, 5.6). The provided excerpts do not specifically state dose reduction/slow titration as the preferred alternative “rather than stopping” for bothersome side effects. |
Moderate |
| Stopping Lyrica suddenly can cause withdrawal-type symptoms for some people. |
Partially Supported |
Label instructs gradual withdrawal to minimize increased seizure frequency (5.6) and to taper over at least 1 week (2.1). The excerpt does not explicitly use the term “withdrawal-type symptoms.” |
Moderate |