Do not take ULTRAM® ER if you have had an allergic reaction to tramadol, codeine,
or other opioids in the past.
ULTRAM® ER tablets must be swallowed whole. Do not chew, crush or split the tablet
before swallowing. This can lead to overdose and possible serious injury including death.
Use of alcohol should be avoided when taking ULTRAM® ER.
The maximum daily dose of ULTRAM® ER is 300 mg. Do not change your dose or stop taking
ULTRAM® ER without talking with your doctor first.
Talk with your doctor about all the medications you are taking. These may include
antidepressants, tranquilizers, hypnotics or other opioid pain medicines. ULTRAM® ER may
impair your ability to perform potentially hazardous tasks, such as driving a car or operating
machinery.
Seizures have been reported in people taking tramadol, the medicine in ULTRAM® ER. The
risk of seizures is increased with doses of tramadol above the recommended range. Use of
tramadol increases the risk of seizures in people taking antidepressants, other opioids, or
other drugs that can cause seizures. Risk of convulsions may also increase in people with
epilepsy or a history of seizures.
ULTRAM® ER may be associated with a potentially life-threatening condition when taken
together with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake
inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs)
(classes of drugs for depression or other disorders), triptans, lithium, or St. John's Wort.
Some common SSRIs are Paxil® (paroxetine), Prozac®/Sarafem® (fluoxetine), and
Zoloft® (sertraline). Some common SNRIs are Cymbalta® (duloxetine) and Effexor®
(venlafaxine). Some common triptans are Axert® (almotriptan), Imitrex® (sumatriptan),
and Relpax® (eletriptan).
If you experience symptoms such as restlessness, hallucinations, loss of coordination, fast
heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea,
vomiting, and diarrhea, contact your doctor immediately.
ULTRAM® ER, like other opioids, can be abused or cause dependence. People who are suicidal
or have a history of drug addiction should not take ULTRAM® ER. Do not take more than the
recommended dose of ULTRAM® ER. Taking more than the recommended dose of ULTRAM® ER, alone
or in combination with alcohol or medications such as tranquilizers, hypnotics or other opioids,
can cause respiratory depression, seizures, overdose and possibly death.
Tell your doctor about all your medical conditions and if you are pregnant, think you might be
pregnant or are trying to become pregnant.
The most common side effects reported with ULTRAM® ER were dizziness, nausea, constipation,
headache, and drowsiness.
Paxil and Imitrex are registered trademarks of GlaxoSmithKline. Prozac and Cymbalta are registered
trademarks of Eli Lilly. Sarafem is a registered trademark of Warner Chilcott. Zoloft and Relpax
are registered trademarks of Pfizer, Inc Effexor is a registered trademark of Wyeth. Axert is
a registered trademark of Almirall Prodesfarma.
