Side Effects by Body System - for Healthcare Professionals

Side Effects by Body System - for Healthcare Professionals

Applies to: oral capsule, extended release; oral tablet; oral tablet, disintegrating; oral tablet, extended release

Gastrointestinal

Gastrointestinal side effects are common. Nausea and constipation occur within the first 90 days of therapy in 40% and 46% of treated patients, respectively. Vomiting, diarrhea, dyspepsia, anorexia, flatulence, abdominal pain, and dry mouth have also been reported.

Nervous system

Seizures have been reported in patients receiving the normal recommended dose. The risk for seizures is increased with doses above the recommended range.

Nervous system side effects occur frequently. Dizziness, headache, and somnolence have been reported in more than 25% of treated patients during the first three months of therapy. CNS stimulation, including nervousness, anxiety, tremor, agitation, euphoria, emotional lability and hallucinations, has also been reported. Confusion, sleep disorders, and coordination disturbances have been reported in less than 5% of patients. Seizures have been reported in over 200 cases. Cases of long-lasting delirium have been reported in two elderly patients. A case of serotonin syndrome triggered by tramadol has also been reported.

Dermatologic

Dermatologic side effects including pruritus (11%) have been reported. Rash and urticaria have occurred rarely.

Genitourinary

Genitourinary side effects including urinary retention and urinary frequency have been reported in less than 5% of treated patients.

Cardiovascular

Cardiovascular side effects including tachycardia and orthostatic hypotension have been reported rarely.

Hypersensitivity

The use of tramadol is contraindicated for patients with a history of allergy to any opioid.

Hypersensitivity side effects including anaphylactoid reactions have been reported after first doses of tramadol as well as in patients with a documented history of codeine allergy. Angioedema has been reported rarely.

Other

Other side effects including withdrawal symptoms and, rarely, auditory hallucinations have been reported. A case of vocal cord closure has also been reported.

Metabolic

Metabolic side effects including hyponatremia have been reported.

Tramadol side effects

Tramadol side effects

Get emergency medical help if you have any of these signs of an allergic reaction to tramadol: 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 tramadol 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.

Tramadol Dosing Information

Tramadol Dosing Information

Usual Adult Tramadol Dose for Pain:

For mild to moderate severe chronic pain not requiring rapid onset of analgesic effect:
Initial dose: 25 mg every morning
Titration: increase in 25 mg increments as separate doses every 3 days to reach 100 mg per day taken as 25 mg 4 times per day. Then the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg per day taken as 50 mg 4 times per day.
Maintenance: After titration, tramadol 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg per day.

For the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time:
Extended-Release Tablets:
Initial Dose: 100 mg once daily and titrated up as necessary by 100 mg increments every five days to relief of pain and depending upon tolerability.
Maximum Dose: Extended-release tablets should not be administered at a dose exceeding 300 mg per day.

For patients in whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial dose:
Dose: 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours, not to exceed 400 mg per day.

Usual Geriatric Tramadol Dose for Pain:

For patients over 65 years:
Dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.

For patients over 75 years:
Maximum dose of regular oral tablets: 300 mg per day in divided doses

Usual Pediatric Tramadol Dose for Pain:

16 years old and up:
Brand name: Ryzolt
Initial: 100 mg once daily
Titrate by 100 mg increments every 2 to 3 days if needed for pain control
Maximum: 300 mg/day

What other drugs will affect tramadol?

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); ormigraine 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.

How should I take tramadol?

How should I take tramadol?

Take tramadol exactly as prescribed. Never take tramadol in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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

Do not crush, chew, or break a tramadol tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. 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.

To take tramadol orally disintegrating tablets (Rybix ODT):

Keep the tablet in its blister pack until you are ready to take it.
Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.
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.

Do not stop using tramadol suddenly, or you could have unpleasant withdrawal symptoms. 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 the amount of medicine used from each new bottle. Tramadol is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.