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. It can be mild or severe, temporary or permanent, but does not occur in everyone. 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
- difficulty sleeping
- drowsiness or weakness
- dry mouth
- hot flushes
- increased sweating
- loss of appetite
- prostate problems
- skin rash
Stop taking the medication and seek immediate medical attention if you develop signs of allergy such as a rash or difficulty breathing.
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.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone at 1-800-332-1088.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use 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 opioids 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/reduced alertness: 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: If you have kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver disease: If you have liver disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
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.
Serotonin syndrome risk: People taking this medication have experienced a potentially life-threatening serotonin syndrome, particularly when this medication was used with certain antidepressants, antibiotics, and carbamazepine. Serotonin syndrome may include agitation, hallucinations, rapid heartbeat, changes in blood pressure, increased temperature, overactive reflexes, incoordination, nausea, vomiting, and/or diarrhea. If you experience any of these symptoms contact your doctor immediately.
Skin reactions: This medication has been associated with serious skin reactions including exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). If you notice symptoms including a rash, itching, blistering, or peeling skin, stop taking this medication and contact your doctor right away.
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.
Breast-feeding: This medication 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.
Seniors. Seniors should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
What other drugs could interact with this medication?
There may be an interaction between acetaminophen - tramadol and any of the following:
- 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)
- SSRIs (e.g., fluoxetine, paroxetine)
- St. John's wort
- tranquilizers or sedatives (e.g., zopiclone)
- triptans (e.g., almotriptan, sumatriptan)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.