What side effects are possible with this medication?

A side effect is an unwanted response to a medication when it is taken in normal doses. A side effect may be mild or severe, temporary or permanent, but does not occur in everyone. Not everyone will experience side effects, and which side effects a person experiences cannot be anticipated.

The following side effects have been reported by at least 1% of people taking this medication. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.

• abdominal pain
• anxiety or nervousness
• confusion
• constipation
• diarrhea
• difficulty sleeping
• dizziness
• drowsiness or weakness
• dry mouth
• euphoria
• gas
• headache
• heartburn
• hot flushes
• increased sweating
• itching
• loss of appetite
• nausea
• prostate problems
• shaking
• skin rash

Click here to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.

Are there any other precautions or warnings for this medication?

Be sure to inform your doctor of all your medical conditions before you begin taking a medication. Some conditions can affect how you should take this medication.

Allergic reactions: Some people may be at risk of serious allergic reactions, called anaphylaxis, when using this medication. When this occurs, it is usually after the first dose. Other allergic reactions include rash, itching, hives, swelling of the mouth area, and difficulty breathing. People with a history of anaphylaxis with codeine or other opiods are at increased risk and should not use this medication. Speak to your doctor if this applies to you.

Dependence: This medication may be habit-forming. Speak to your doctor about your risk of dependence.

Drowsiness and occupational hazards: This medication may cause drowsiness, which could impair your ability to do activities requiring alertness, such as driving a car or operating machinery. Avoid these activities until you know how the medication affects you.

Kidney disease: People with severely reduced kidney function may need lower doses of this medication. If you have kidney disease, speak to your doctor.

Liver disease: This medication is not recommended for people with liver disease. If you have liver disease, speak to your doctor for guidance.

Other products containing acetaminophen: This medication contains acetaminophen. Acetaminophen can cause liver damage if the recommended dose is exceeded. Avoid other medications containing acetaminophen, such as cough and cold products, while you are using acetaminophen - tramadol. Check the label of all medications you take to see if they contain acetaminophen.

Respiratory depression: People using anesthetic medications or alcohol may be at risk of respiratory depression if they are also taking large doses of tramadol. Speak to your doctor if this applies to you.

Seizures: People taking this medication have experienced seizures. Some people may be at increased risk of seizures with this medication, including those with epilepsy, a metabolic disorder, a history of seizures, recent head trauma, or a brain infection. People experiencing withdrawal from drugs or alcohol could also be at risk. As well, those taking certain medications, such as narcotics or certain antidepressants, may have a higher risk of seizures. Speak to your doctor about your risk of seizures if any of these situations apply to you.

Stopping the medication: Stopping this medication suddenly could lead to withdrawal symptoms such as anxiety, sweating, trouble sleeping, muscle stiffness, pain, nausea, shaking, diarrhea, goosebumps, or hallucinations. If you are thinking of stopping the medication, talk to your doctor about how to stop it safely.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately to talk about the benefits and risks of using this medication.

Breast-feeding: Tramadol passes into breast milk. If you are a breast-feeding mother and are taking tramadol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of this medication have not been established in children.

What other drugs could interact with this medication?

An interaction between medications does not always mean that you must stop taking one of them. The following medications may affect the way acetaminophen-tramadol works, be affected by acetaminophen-tramadol, or increase the risk of side effects:

• alcohol
• amitriptyline
• carbamazepine
• MAO inhibitors (e.g., phenelzine, tranylcypromine)
• narcotics (e.g., morphine, codeine)
• other products containing acetaminophen (such as cough and cold products)
• other products containing tramadol
• phenothiazines (e.g., prochlorperazine, chlorpromazine)
• quinidine
• SSRIs (e.g., fluoxetine, paroxetine)
• tranquilizers or sedatives (e.g., zopiclone)

If you are taking any of these or other medications (including non-prescription, herbal, and supplement products), speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want to change your therapy or may suggest ways of managing any interactions. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your doctor know if you use them. Medications other than those listed above may also interact with this medication.