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This document outlines essential safety information and warnings about using pregabalin (Lyrica). Please review these details carefully and discuss any concerns with your healthcare provider.

• Allergic Reactions and Severe Swelling: Although infrequent, pregabalin may cause angioedema, which involves swelling of the face, tongue, neck, or other organs and can be life-threatening if it affects breathing. If you experience any swelling, hives, red skin, blisters, or difficulty breathing, seek medical attention immediately. Increased risk is associated with a history of unusual swelling or concurrent use of other medications that may cause swelling.

• Suicidal Thoughts and Behavior: Pregabalin, like other anti-seizure medications, can increase the risk of suicidal thoughts or behavior, which may occur as soon as one week after starting the medication. Report any new or worsening depression symptoms or mood changes to your provider immediately. Risks are higher for those taking anti-seizure medications or with a history of depression.

• Difficulty Driving and Concentrating: Pregabalin may cause drowsiness and impair concentration, particularly when starting the medication or at higher doses. Avoid driving or operating heavy machinery until you understand how pregabalin affects you. The risk is heightened if you consume alcohol or use other medications that cause drowsiness.

• Breathing Problems: Avoid using pregabalin with medications that depress the central nervous system (CNS), such as opioids, as this combination can lead to severe breathing issues. Those with a history of breathing problems or who take CNS depressants are at greater risk. If breathing difficulties occur, seek emergency medical care.

• Swelling in the Limbs and Weight Gain: Pregabalin may cause limb swelling, especially when used with certain diabetes medications like pioglitazone (Actos). Inform your healthcare provider if you have heart problems, as additional fluid may worsen conditions like heart failure. Contact your provider if significant swelling occurs.

• Withdrawal Symptoms and Seizure Risk: Do not abruptly discontinue pregabalin without consulting your provider. Sudden cessation can cause withdrawal symptoms, such as nausea, headaches, insomnia, sweating, and diarrhea, and may increase seizure risk if used for seizure control. Your provider will assist in gradually reducing the dose.

• Risk of Bleeding from Low Platelet Levels: Some individuals on pregabalin have experienced decreased platelet levels, potentially increasing bleeding risk. If you notice unusual bleeding, like blood in urine or stool, easy bruising, or prolonged bleeding, inform your provider for a platelet count check.

• Possible Risk of Muscle Breakdown: Rarely, pregabalin might increase the risk for rhabdomyolysis, a condition where muscles break down. Seek medical advice if you experience unexplained muscle pain, tenderness, or weakness.

Please consult your healthcare provider for any further information or clarification needed regarding these warnings.

Common side effects:

• Dizziness
• Drowsiness
• Dry mouth
• Constipation
• Weight gain
• Swelling of the hands, feet, arms, or legs
• Difficulty concentrating or paying attention

Less common but important to monitor:

• Weakness
• Poor coordination or movement
• Blurry or abnormal vision
• Accidental injuries

Serious side effects:

• Angioedema
• Severe allergic reactions
• Severe drowsiness
• Breathing problems
• Suicidal thoughts and behaviors
• Very serious allergic reaction

Interactions with high risk of serious adverse effects and should be avoided:

• orlistat

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• opioid pain or cough medications (such as codeine, hydrocodone)
• alcohol
• marijuana (cannabis)
• drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem)
• muscle relaxants (such as carisoprodol, cyclobenzaprine)
• antihistamines (such as cetirizine, diphenhydramine)