Take this medication with a full glass of water.

Tramadol can be taken with or without food, but take it the same way each time.

Do not crush the tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhalation or injection can cause life-threatening side effects, overdose, or death. Do not crush, chew, break, or open a controlled-release, delayed-release, or extended-release tablet or capsule. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

Take this medication by mouth with or without food as directed by your doctor. If you have nausea, you may take this drug with food. Consult your doctor or pharmacist about other ways to decrease nausea (e.g., antihistamines, lying down for 1 to 2 hours with as little head movement as possible).

The dosage is based on your medical condition and response to treatment. To reduce the risk of side effects, your doctor may tell you to gradually increase your dose when starting tramadol.

The maximum recommended dose is 400 milligrams a day. If you have serious kidney disease (e.g., if you are on dialysis), the maximum recommended dose is 100 milligrams every 12 hours. If you have serious liver disease (e.g., cirrhosis), the maximum recommended dose is 50 milligrams every 12 hours. If you are older than 75 years, the maximum recommended dose is 300 milligrams a day.

Pain medications work best if they are used as the first signs of pain (or migraine) occur. If you wait until the pain has worsened, the medication may not work as well.

Follow your doctor’s or pharmacist’s instruction for the safe use of non-narcotic pain relievers (e.g., acetaminophen, ibuprofen). Ask your doctor or pharmacist for more details regarding your treatment.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as anxiety, sweating, sleeplessness, shaking, diarrhea, rapid breathing) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Also, if you are taking regular doses of narcotic medications for ongoing pain (e.g., cancer pain), starting tramadol may cause a withdrawal reaction. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Tell your doctor if your pain persists or worsens.

If you use the tramadol extended-release tablet, the tablet shell may pass into your stools (bowel movements). This is normal and does not mean that you are not receiving enough of the medicine.

Tramadol may be habit-forming. Tell your doctor if you feel the medicine is not working as well in relieving your pain. Do not change your dose without talking to your doctor. Do not stop using tramadol suddenly, or you could have unpleasant withdrawal symptoms such as anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Store tramadol at room temperature away from moisture and heat. Keep track of how many pills have been used from each new bottle of this medicine. Tramadol is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

• an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam); or
• an antidepressant such as amitriptyline (Elavil), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor); paroxetine (Paxil), or sertraline (Zoloft).

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious (possibly fatal) interactions may occur: MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine).

Avoid taking MAO inhibitors within 2 weeks before, during, and after treatment with tramadol.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting tramadol.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other narcotic medications.

Before using tramadol, report the use of other drugs that increase serotonin, such as dextromethorphan, lithium, St. John’s wort, sibutramine, street drugs such as MDMA/”ecstasy”, tryptophan, certain antidepressants including SSRIs (such as citalopram, paroxetine) and SNRIs (such as duloxetine, venlafaxine), “triptans” used to treat migraine headaches (such as eletriptan, sumatriptan), among others. The risk of serotonin syndrome may be more likely when you start or increase the dose of these medications.

Also report the use of drugs that might increase seizure risk when combined with tramadol such as isoniazid (INH), phenothiazines (e.g., thioridazine, chlorpromazine, promethazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details.

Other medications can affect the removal of tramadol from your body, which may affect how tramadol works or increase the risk of side effects. These drugs include quinidine, azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), drugs used to treat seizures (such as carbamazepine, phenytoin), and St. John’s wort. This is not a complete list.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as certain antihistamines (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., phenytoin), medicine for sleep (e.g., zolpidem), muscle relaxants (e.g., cyclobenzaprine).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Before taking tramadol, tell your doctor if you also use:

• carbamazepine (Tegretol);
• warfarin (Coumadin);
• digoxin (Lanoxin, Lanoxicaps);
• ketoconazole (Nizoral);
• erythromycin (E-Mycin, E.E.S., Ery-Tab);
• rifampin (Rifadin, Rimactane, Rifater);
• St. John’s wort;
• quinidine (Quinaglute, Quinadex, Cardioquin, Quinora); or
• drugs that make you sleepy (such as cold medicine, other pain medications, muscle relaxants, and medicine for seizures, depression or anxiety).

This list is not complete and there may be other drugs that can interact with tramadol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Take tramadol exactly as it was prescribed for you. Do not take it in larger doses or for longer than recommended by your doctor. Do not take more than 300 milligrams of tramadol in one day.

Seek emergency medical attention if you think you have used too much of this medicine. A tramadol overdose can be fatal. Overdose symptoms of a tramadol overdose may include drowsiness, shallow breathing, slow heartbeat, extreme weakness, cold or clammy skin, feeling light-headed, fainting, or coma.

Before taking tramadol, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (e.g., codeine); or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., respiratory depression, hypercapnia), intoxication with drugs that depress the nervous system or your breathing (CNS/respiratory depressants such as alcohol or tranquilizers/sedatives).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain bowel diseases (paralytic ileus), brain disorders (e.g., seizures, increased intracranial pressure), conditions that increase the risk of seizures (e.g., head injury, brain tumors, meningitis, metabolic disorders, alcohol/drug withdrawal), adrenal gland problem (e.g., Addison’s disease), difficulty urinating (e.g., enlarged prostate, urethral narrowing), heart problems (e.g., irregular heartbeat), personal or family history of regular use/abuse of drugs/alcohol, kidney disease, liver disease, lung diseases (e.g., chronic obstructive pulmonary disease-COPD, hypoxia), disease of the pancreas (e.g., pancreatitis), mental/mood conditions (e.g., major depression, toxic psychosis), a certain spinal problem (kyphoscoliosis), stomach/intestinal problems (e.g., gallbladder disease), underactive thyroid (hypothyroidism).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing and drowsiness.

During pregnancy, this medication should be used only when clearly needed. It is not recommended for use for long periods or in high doses late in pregnancy because of possible serious harm to your baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have seizures or withdrawal symptoms such as irritability, abnormal/persistent crying, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This drug passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Tramadol may be habit-forming and should be used only by the person it was prescribed for. Tramadol should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Tramadol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not stop using tramadol suddenly, or you could have unpleasant withdrawal symptoms such as anxiety, sweating, nausea, diarrhea, tremors, chills, hallucinations, trouble sleeping, or breathing problems. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Do not crush the tramadol tablet. This medicine is for oral (by mouth) use only. Powder from a crushed tablet should not be inhaled or diluted with liquid and injected into the body. Using this medicine by inhalation or injection can cause life-threatening side effects, overdose, or death.

• 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.

Tramadol side effects includes:

Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, headache, or weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you are taking tramadol regularly, it may be useful to start using a laxative right away instead of waiting until you become constipated. Consult your pharmacist for details regarding the correct use of laxatives (e.g., stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual or extreme stiffness in the muscles, shaking (tremor), severe stomach/abdominal pain, change in the amount of urine, vision changes.

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs (see Drug Interactions section). Seek immediate medical attention if you develop some of the following symptoms: mental/mood changes (such as agitation, hallucinations), unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitchy muscles.

Tell your doctor immediately if any of these rare but very serious side effects occur: slow/shallow breathing, seizures, fever/flu-like symptoms.

A very serious allergic reaction to this drug (which may occur as early as the first dose) is rare. However, seek immediate medical attention if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Less serious tramadol side effects may include:

• dizziness, drowsiness, weakness;
• nausea, vomiting, constipation, loss of appetite;
• blurred vision;
• flushing (redness, warmth, or tingly feeling); or
• sleep problems (insomnia).

1. This is the only medicine I’ve ever found to actually work on my tension headaches. I have used it about 2 – 3 times a year for a few to several days in a row to knock out my headaches. This is my ‘last resort’ medication and for great reason – it works. As someone else posted, if this doesn’t work, nothing is going to work. I’m so thankful for this medication.

2. I have been having headaches for about five months and the doctor prescribed me Fioricet and it does nothing for my headaches.

3. I use Fioricet on regular basis and most of the time it seems to help.

4. Fioricet does wonders! It helps my tension headaches, especially when I am stressed!

5.I was getting cluster headaches for about 3 weeks. Went to ER and they gave me a shot of Stadol, but that didn’t even take my headache away. Got Fioricet prescription filled next day (today). Haven’t had a headache all day.

6.I have had almost daily headaches since I was 15. I am now 43. I would not have believed such a simple medication would have worked so well.

7.I have brain tumors and Fioricet works wonders. It makes the pain go away in about an hour. I couldn’t live without this wonder drug.

8.Works great but it does make me sleepy at first. I have found that I only have to take it once and my headache is gone for the rest of the day!

9.I have been a suffering from migraine headaches for 20 years. I’ve tried EVERYTHING. My experience has shown if you take 2 tablets of Fioricet at the onset of one, you will do yourself a huge favor. It works. It may not eliminate your migraine but it will make it tolerable and less severe. Like others above, you have to be careful about how much you do take. I’ve found if I had a bad headache and have taken several pills, I have to then ween myself off of it by taking one pill every 4 hours over the next day or so to prevent a rebound headache. If you take many of these to relieve a headache, I recommend taking a few when your headache is gone to prevent a rebound. I make sure I carry my Fioricet with me at all times.

10.Have been using this drug for about 16 years now. No other migraine medicine compares to it. Have recommended it to several other migraine sufferers. In turn they have called their doctors and now they are on it. They have had the same luck I have.

11.I was not one prone to headaches until recently. They started at the base of my neck and continued upward until I didn’t want to move a muscle. Oddly enough, these were prescribed by my dentist due to an upcoming root canal I was getting ready for. I took one the next time I had a headache and within 30 minutes it was completely gone. I was amazed.

12.BEWARE – THIS DRUG MAY GIVE REBOUND HEADACHES.

13.For the first six months it worked great but now it doesn’t relieve my headaches at all. In fact the only thing it does is gives me insomnia.

14.I have tried just about every option available and this medication has been the only one to truly relieve my headache AND allow me to feel “normal” so that I am able to function.
15.This is a wonderful drug. It takes the pain away within a few minutes and even if the migraine doesn’t go away altogether, the pain isn’t as bad as it would be or could be, without some form of medication. Believe me I’ve tried them all. I am now on Topamax 50mg twice a day, Fioricet and Midrin.

16.I GET PROBABLY 4 OR 5 MIGRAINES A MONTH. I COULDN’T BEAR TO BE WITHOUT MY FIORICET. IT’S THE ONLY MEDICINE THAT SEEMS TO WORK FOR ME. IF I FEEL A HEADACHE STARTING, I TAKE 2 TABS AND WITHIN 20-30 MINS, THE HEADACHE IS GONE. IN ADDITION TO BEING A MOTHER OF 4 GIRLS, I HAVE RUN MY FAMILY DAY CARE FOR 17 YEARS AND I JUST WOULDN’T BE ABLE TO FUNCTION WITHOUT MY FIORICET. I HAVE TRIED SEVERAL OTHER MEDICINESS BEFORE FIORICET, AND NOTHING SEEMED TO HELP SO I AM VERY THANKFUL FOR FIORICET. IT WORKS GREAT FOR ME. I’VE TRIED TO AVOID THINGS THAT SET OFF MY HEADACHES, LIKE NOT EATING BEFORE 2 PM, OR MY PILLOWS NOT BEING RIGHT WHEN SLEEPING, BRIGHTNESS, SOUNDS, SMELLS AND STRESS. BUT SOME CAN’T BE AVOIDED. THANK YOU.

This drug should not be used with the following medication because very serious interactions may occur: sodium oxybate.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting this medication.

The following drugs can interact with Fioricet. Tell your doctor if you are using any of these:

• an antibiotic;
• a blood thinner such as warfarin (Coumadin);
• isoniazid;
• zidovudine (Retrovir, AZT);
• seizure medication such as phenytoin (Dilantin) or phenobarbital (Luminal, Solfoton);
• gout medications such as probenecid (Benemid) or sulfinpyrazone;
• an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
• steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; or
• an antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with Fioricet. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: adenosine, anti-seizure drugs (e.g., carbamazepine, phenytoin), beta agonists (e.g., albuterol), drugs affecting liver enzymes that remove this medication from your body (such as macrolide antibiotics including erythromycin, cimetidine, disulfiram, valproic acid, fluvoxamine, MAO inhibitors including furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine), isoniazid, lithium, methoxyflurane, phenothiazines (e.g., chlorpromazine).

This drug can speed up the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include “blood thinners” (e.g., warfarin), cyclosporine, corticosteroids such as prednisone, estrogen, felodipine, metronidazole, quinidine, certain beta blockers such as metoprolol, theophylline, doxycycline.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as certain antihistamines (e.g., diphenhydramine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain caffeine or drowsiness-causing ingredients. Also keep in mind that certain beverages (e.g., coffee, colas, tea) contain caffeine. Ask your pharmacist about using those products safely.

Acetaminophen is an ingredient in many nonprescription products and in some combination prescription medications. Read the labels carefully before taking other pain relievers, fever reducers, or cold products to see if they also contain acetaminophen. Consult your pharmacist if you are uncertain whether your other prescription or nonprescription products contain acetaminophen. (See also adult maximum daily dose information in Side Effects section.)

This medication may decrease the effectiveness of combination-type birth control pills. This can result in pregnancy. Ask your doctor or pharmacist for details, and discuss whether you should use additional reliable birth control methods while taking any of these drugs.

This medication may interfere with certain medical/laboratory tests (including urine 5-HIAA levels, urine VMA levels, urine catecholamine levels, dipyridamole-thallium imaging tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Nausea, vomiting, abdominal pain, shaking (tremor), shortness of breath, lightheadedness, dizziness, or drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, fainting, seizure, fast/irregular heartbeat, increased thirst/urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, change in the amount of urine.

If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams per day (4000 milligrams). If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. Seek immediate medical attention if you have any of the following symptoms of liver damage: persistent nausea/vomiting, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, extreme tiredness.

If you have liver problems, consult your doctor or pharmacist for a safe dosage of this medication.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Fioricet with Codeine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fioricet with Codeine:

Dizziness; drowsiness; intoxicated feeling; lightheadedness; nausea; stomach pain; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Fioricet with Codeine:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fainting; fast heartbeat; mental or mood changes; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe drowsiness; shortness of breath; slow or shallow breathing.