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The following safety information outlines important considerations and potential risks associated with the use of pregabalin ER (Lyrica CR). Please review these points carefully and consult with your healthcare provider if you have any questions or concerns.

• Severe Allergic Reactions and Angioedema: Be aware that severe allergic reactions, including life-threatening symptoms like facial swelling and anaphylaxis, can occur. Pregabalin ER (Lyrica CR) may also cause angioedema, resulting in swelling of the face, throat, and tongue, especially if you are on ACE inhibitors. Seek immediate medical attention if you experience these symptoms.

• Suicidal Thoughts and Behavior: Although rare, pregabalin ER (Lyrica CR) can increase the risk of suicidal thoughts or self-harm. Regular screening for depression and suicidal ideation may be conducted by your healthcare team. If you or others notice any unusual thoughts or behavior, such as depression or anxiety, contact your prescriber immediately.

• Respiratory Depression: This medication can slow breathing, which can be serious or life-threatening, particularly if you have lung issues or combine it with other CNS depressants or alcohol. If you notice symptoms like excessive sleepiness or shallow breathing, seek medical care right away.

• Withdrawal Symptoms: Stopping pregabalin ER (Lyrica CR) suddenly may lead to withdrawal symptoms such as nausea, headache, insomnia, anxiety, and diarrhea. Consult your prescriber before changing your dose, as they will guide you to taper off the medication gradually.

• Cognitive Impairment and Drowsiness: Pregabalin ER (Lyrica CR) may cause dizziness, sleepiness, or difficulty concentrating. These effects may be intensified if taken with other sedatives. Understand how the medication affects you before driving or performing tasks requiring focus. Contact your prescriber if excessive drowsiness occurs.

• Peripheral Edema: Swelling of hands and feet may occur, especially if taken with certain diabetes medications or if you have heart failure. Persistent swelling should be reported to your healthcare provider, as it may exacerbate heart failure.

• Weight Gain: Some individuals may experience weight gain, particularly with higher doses or prolonged use. Discuss any concerns with your healthcare provider, who can advise on dietary and exercise strategies to help manage weight.

• Vision Changes: Report any changes in vision, such as blurriness, to your healthcare team promptly for evaluation and guidance.

• Thrombocytopenia: Although rare, pregabalin ER (Lyrica CR) may reduce platelet count, increasing bleeding risk. If you experience uncontrolled bleeding or symptoms like dizziness or fainting, seek immediate medical attention.

Common side effects:

• drowsiness
• dizziness
• headache
• dry mouth
• nausea
• constipation
• potential weight gain
• swelling in the hands and feet
• blurred vision
• vertigo
• tiredness
• cough

Less common but important to monitor:

• double vision
• diarrhea
• vomiting
• erectile dysfunction

Serious side effects:

• significant allergic reactions
• rash
• hives
• swelling of the face, lips, or tongue
• difficulty breathing
• changes in mood or behavior
• depression
• anxiety
• panic attacks
• suicidal thoughts
• slowed or shallow breathing
• extreme sleepiness or fatigue

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

• opioid pain relievers (such as codeine, hydrocodone)

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

• orlistat
• alcohol
• marijuana (cannabis)
• sleep or anxiety medications (such as alprazolam, lorazepam, zolpidem)
• muscle relaxants (such as carisoprodol, cyclobenzaprine)

Interactions with low risk that usually do not require a change in therapy:

• antihistamines (such as cetirizine, diphenhydramine)