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Tramadol is a centrally-acting, oral narcotic-like analgesic and is approved for the treatment of moderate to moderately severe pain in adults. The extended-release form of tramadol is for around-the-clock treatment of pain and not for use on an as-needed basis for pain. A combination product of tramadol and acetaminophen (Ultracet) is also available by prescription. In 2013, over 43 million tramadol prescriptions were written in the U.S, according to IMS.
In 1995, tramadol was originally approved by the U.S. Food and Drug Administration (FDA) as a non-controlled analgesic. However, since 1995, changes to the controlled substance status of tramadol have been made due to reports of drug abuse and diversion. The Drug Abuse Warning Network (DAWN) reported that roughly 20,000 emergency department visits were related to tramadol non-medical use in 2011. According to the National Survey on Drug Use and Health (NSDUH) in 2012, 3.2 million people in the U.S. aged 12 or older used tramadol for nonmedical purposes.
1. Tramadol is now a controlled substance in all 50 U.S. states.
On July 7, 2014 the U.S. Drug Enforcement Administration (DEA) announced that tramadol has been placed into schedule IV of the Controlled Substances Act (CSA) effective August 18, 2014.
The new scheduling applies to all forms of tramadol. The rescheduling of tramadol comes at a time of growing concern related to abuse, misuse, addiction and overdose of opioid analgesics.
Previously tramadol was a controlled substance in only a few states.
Starting August 18, 2014 tramadol prescriptions may only be refilled up to five times within a six month period after the date on which the prescription was written. After five refills or after six months, whichever occurs first, a new prescription is required. This rule applies to all controlled substances in schedule III and IV.
2. Tramadol is associated with a wide array of side effects.
In many people, tramadol is well-tolerated when used for pain, but tramadol can also cause some common and serious side effects. It is important to review with your doctor the side effects that have been reported with tramadol before starting treatment. Side effects with tramadol may worsen with higher doses.
Common side effects may include:
- itching
- headache
- diarrhea
- nausea
- vomiting
- constipation
- dizziness
- drowsiness
- impaired mental abilities
Serious (but less common or even rare) side effects may include:
- seizures
- serotonin syndrome
- depressed breathing
- life-threatening allergic reactions
- angioedema, or swelling under the skin
- possibly fatal skin reactions
- orthostatic hypotension (low blood pressure that occurs when you stand up from sitting or lying down)
- suicide thoughts or action
- withdrawal symptoms
- Seizures have occurred in patients taking recommended doses but are more likely at high doses associated with abuse of tramadol.
Do not abruptly stop taking tramadol as withdrawal symptoms like nausea, diarrhea, anxiety, or tremors may occur. Consult with your doctor for a tapering dose schedule if you are stopping tramadol treatment.
3. Dangerous drug interactions are possible with tramadol.
Tramadol may cause a dangerous condition known as “serotonin syndrome”. Patients receiving serotonergic drugs such as the migraine agents called “triptans” may be at a higher risk for serotonin syndrome. Brand names of triptans include Imitrex, Zomig, Frova, Maxalt, Axert, Amerge, and Relpax.
Do not take tramadol if you have used alcohol, sedatives, tranquilizers, or narcotic medications. Tramadol should not be combined with these medications or with alcohol at any time. Patients should avoid driving or other activities that require mental alertness until the effects of the drug are known.
Patients should always have a drug interaction review completed each time they start a new medication, including herbal, over-the-counter, and supplement drugs.
4. Tramadol can be habit-forming.
Tramadol is structurally related to the opioids like codeine and morphine and can lead to psychological and physical dependence, addiction, and withdrawal. People with a history of a drug-seeking behavior may be at greater risk of addiction, but illicit actions to obtain the drug can occur in people without a prior addiction, as well.
Do not abruptly stop taking tramadol as withdrawal symptoms like nausea, diarrhea, anxiety, sweating, difficulty in sleep, shivering, pain, tremors, or rarely, hallucinations may occur.
Consult with your doctor before discontinuing tramadol treatment; do NOT discontinue treatment on your own. Withdrawal symptoms may be relieved by re-initiation of opioid therapy followed by a slow, dose reduction combined with symptomatic support, as directed by your doctor.
5. Support groups exist within Drugs.com.
Support groups may be helpful for patients who take tramadol, who use medications for pain relief, who are in need of addiction support, and for many other needs. Joining one or more support groups is a great way to discover others with related medications and similar conditions, find out more information and share your own experience.
- Tramadol Support Group
- Ultram Support Group
- Fibromylagia Support Group
- Pain Support Group
- Addiction Support Group
- Opiate Dependence
- Depression Support Group
6. Tramadol is available in both immediate-release and extended-release formulations.
Both the immediate-release and extended-release formulation of tramadol are available generically and can possibly save you hundreds of dollars on your prescription.
If you prefer generic medications due to cost-savings, ask your physician to only write for generic drugs whenever possible. If you cannot afford your medication, do not walk away from the pharmacy. Ask your doctor or pharmacist for more affordable alternatives.
Tramadol extended-release tablets must be taken whole, not split, chewed or crushed.
Learn more about generic drugs in “Facts About Generic Drugs”.
7. Dose adjustments are needed in the elderly, and in those with kidney or liver problems.
As with many medications, if you are young, elderly, or have kidney or liver disease dose adjustments are often required. The dosing interval (how often you take the drug) may be adjusted, the actual dose of the drug may be reduced, and you may have a maximum dose you should not exceed per day. Talk to your doctor about the need for adjusted doses with any medication.
- Patients older than 65 years of age
Doses should usually start at the low end of the dosing range and can be titrated upwards slowly based on tolerance and effectiveness.
- Patients older than 75 years of age
Maximum dose of regular-release oral tablets: 300 mg per day in divided doses.
Kidney Disease
Over 30 percent of tramadol is excreted by the kidneys as the unchanged molecule, which could lead to toxic blood levels in patients with kidney disease.
Creatinine clearance is a lab test that measures how well your kidneys are working. If you use the immediate-release form of tramadol (not the ER form), and have a creatinine clearance of less than 30 (severe kidney disease), your dosing interval should be increased to every 12 hours, and the maximum daily dose of tramadol is 200 milligrams (mg).
Do not use the extended-release form of tramadol if your creatinine clearance is less than 30 (severe kidney disease).
Liver Disease
In patients with cirrhosis, the regular-release tablets and oral disintegrating tablets can be given at a dose of 50-mg orally every 12 hours, with a maximum dose of 100-mg per day.
Extended-release tablets and the brand name form of tramadol called Ryzolt should not be used in patients with severe hepatic impairment (Child-Pugh Class C).
8. There are ways to engage with other patients using tramadol.
There are over 700 reviews for tramadol from patients who use this drug for pain, back pain and other various conditions (some of which may be off-label use, meaning the drug is not approved by the FDA for that particular use). Here you can ask a question, share an experience and see other ratings from patients who are using tramadol for various conditions.
Remember, the information is NOT intended to endorse tramadol or recommend therapy. While these reviews might be helpful to you, they are NOT a substitute for the expertise, skill, knowledge and judgement of healthcare practitioners in patient care.
