Do not drink alcohol. It may cause a dangerous decrease in your breathing when used together with tramadol.

Tramadol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tramadol and call your doctor at once if you have any of these serious side effects:

• agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

• seizure (convulsions);

• a red, blistering, peeling skin rash; or

• shallow breathing, weak pulse.

Less serious side effects may include:

• dizziness, spinning sensation;

• constipation, upset stomach;

• headache;

• drowsiness; or

• feeling nervous or anxious.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may be more likely to have a seizure (convulsions) if you take tramadol while you are using certain other medicines. Do not take tramadol without telling your doctor if you also use any of the following medications:

• an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or

• an antidepressant such as amitriptyline (Elavil, Vanatrip), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), or sertraline (Zoloft).

Cold or allergy medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by tramadol. Tell your doctor if you regularly use any of these medicines, or any other pain medication.

Tell your doctor about all other medicines you use, especially:

• carbamazepine (Carbatrol, Equetro, Tegretol);

• lithium (Eskalith, LithoBid);

• ADHD medications (Adderall, Ritalin, Strattera);

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), linezolid (Zyvox), rifampin (Rifadin, Rimactane, Rifater); or telithromycin (Ketek);

• antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);

• cancer medications such as gefitinib (Iressa), imatinib (Gleevec), or nilotinib (Tasigna);

• a heart rhythm medication such as amiodarone (Cordarone, Pacerone), flecainide (Tambocor), propafenone (Rythmol), or quinidine (Quin-G);

• heart or blood pressure medication such as diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others;

• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra); or

• migraine headache medicine such as sumatriptan (Imitrex, Treximet).

This list is not complete and there are many other drugs that can interact with tramadol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Your pharmacist can provide more information about tramadol.