Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tramadol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to tramadol or narcotic analgesics. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Although studies on birth defects have not been done in pregnant women, tramadol has not been reported to cause birth defects. In animal studies, there were drug-related birth defects observed. Studies done in animals given very high (toxic) doses resulted in lower than normal birth weights and some deaths in the fetuses and birth defects in some of the newborns. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Tramadol passes into breast milk and may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—There is no specific information on the relationship of age to the effects of tramadol tablets in patients less than 16 years of age and tramadol extended-release tablets in patients less than 18 years of age.

Older adults—Studies in older adults show that tramadol stays in the body a little longer than it does in younger adults. Your doctor will consider this when deciding on your doses.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking tramadol, it is especially important that your health care provider know if you are taking any of the following:
Carbamazepine (e.g., Tegretol)—May decrease the effects of tramadol by decreasing the amount of medicine in the body
Central nervous system (CNS) depressants (medicines that cause drowsiness)—Using these medicines with tramadol may increase the chance of serious side effects or increase the risk of convulsions (seizures).
Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—The chance of convulsions (seizures) may be increased.
Neuroleptic drugs (antipsychotic drugs) (chlorpromazine [e.g., Thorazine], clozapine [e.g., Clozaril], haloperidol [e.g., Haldol], loxapine [e.g., Loxitane]) or
Other drugs that lower seizure threshold (epilepsy drugs)—May increase chances of seizures so caution is recommended

Other medical problems—The presence of other medical problems may affect the use of tramadol. Make sure you tell your doctor if you have any other medical problems, especially:
Abdominal or stomach conditions (severe)—Tramadol may hide signs of other medical conditions.
Addiction problems or
Suicidal—Tramadol should not be used.
Alcohol or drug abuse, or history of—May increase the serious side effects of tramadol
Epilepsy or
History of seizures
Increased risk for seizures caused by alcohol and drug withdrawal, brain or spinal cord infections, or head trauma—Risk of seizures may be increased.
Head injury—Tramadol can hide signs of other medical conditions.
Kidney disease or
Liver disease—The chance of side effects may be increased. Your doctor will consider this when deciding on your doses.