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Ultram ER

Last reviewed on RxList: 12/15/2016
Ultram ER Side Effects Center

Last reviewed on RxList 12/22/2016

Ultram ER (tramadol extended-release) is a narcotic-like pain reliever that is used to treat moderate to severe pain when treatment is needed around the clock. Side effects of Ultram ER include:

Tell your doctor if you have unlikely but serious side effects of Ultram ER including:

The initial adult dose of Ultram ER is 100 mg once daily, and titrated up as necessary by 100-mg increments every five days to relief of pain and depending upon tolerability. Ultram ER may interact with MAO inhibitors, antidepressants, cold or allergy medicine, sleeping pills, muscle relaxers, medicine for seizures or anxiety, other pain medications, carbamazepine, lithium, ADHD medications, antibiotics, antifungals, cancer medications, heart rhythm medications, heart or blood pressure medications, HIV/AIDS medicines, or migraine headache medicines. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant while using Ultram ER. It is unknown if it will harm a fetus. Infants born to mothers who use Ultram ER close to delivery may have withdrawal symptoms. Ultram ER passes into breast milk and may harm a nursing baby. Breastfeeding while using Ultram ER is not recommended. Withdrawal symptoms may occur if you suddenly stop taking Ultram ER.

Our Ultram ER Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

Ultram ER Consumer Information

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

Read the entire detailed patient monograph for Ultram ER (Tramadol HCl Extended-Release)

Ultram ER Professional Information

SIDE EFFECTS

ULTRAM ER was administered to a total of 3108 patients during studies conducted in the U.S. These included four double-blind studies in patients with osteoarthritis and/or chronic low back pain and one open-label study in patients with chronic nonmalignant pain. A total of 901 patients were 65 years or older. The frequency of adverse events generally increased with doses from 100 mg to 400 mg in the two pooled, twelve-week, randomized, double-blind, placebo-controlled studies in patients with chronic non-malignant pain (see Table 2).

Table 2: Incidence (%) of patients with adverse event rates ≥ 5% from two 12-week placebo-controlled studies in patients with moderate to moderately severe chronic pain by dose (N=1811).

MedDRA Preferred Term ULTRAM ER Placebo
100 mg
(N=403)
n (%)
200 mg
(N=400)
n (%)
300 mg
(N=400)
n (%)
400 mg
(N=202)
n (%)
(N=406)
n (%)
Dizziness (not vertigo) 64 (15.9) 81 (20.3) 90 (22.5) 57 (28.2) 28 ( 6.9)
Nausea 61 (15.1) 90 (22.5) 102 (25.5) 53 (26.2) 32 ( 7.9)
Constipation 49 (12.2) 68 (17.0) 85 (21.3) 60 (29.7) 17 ( 4.2)
Headache 49 (12.2) 62 (15.5) 46 (11.5) 32 (15.8) 43 (10.6)
Somnolence 33 ( 8.2) 45 (11.3) 29 ( 7.3) 41 (20.3) 7 ( 1.7)
Flushing 31 ( 7.7) 40 (10.0) 35 ( 8.8) 32 (15.8) 18 ( 4.4)
Pruritus 25 ( 6.2) 34 ( 8.5) 30 ( 7.5) 24 (11.9) 4 ( 1.0)
Vomiting 20 ( 5.0) 29 ( 7.3) 34 ( 8.5) 19 ( 9.4) 11 ( 2.7)
Insomnia 26 ( 6.5) 32 ( 8.0) 36 ( 9.0) 22 (10.9) 13 ( 3.2)
Dry Mouth 20 ( 5.0) 29 ( 7.3) 39 ( 9.8) 18 ( 8.9) 6 ( 1.5)
Diarrhea 15 ( 3.7) 27 ( 6.8) 37 ( 8.5) 10 ( 5.0) 17 ( 4.2)
Asthenia 14 ( 3.5) 24 ( 6.0) 26 ( 6.5) 13 ( 6.4) 7 ( 1.7)
Postural hypotension 7 ( 1.7) 17 ( 4.3) 8 ( 2.0) 11 ( 5.4) 9 ( 2.2)
Sweating increased 6 ( 1.5) 8 ( 2.0) 15 ( 3.8) 13 ( 6.4) 1 ( 0.2)
Anorexia 3 ( 0.7) 7 ( 1.8) 21 ( 5.3) 12 ( 5.9) 1 ( 0.2)

The following adverse events were reported from all the chronic pain studies (N=3108).

The lists below include adverse events not otherwise noted in Table 2.

Adverse events with incidence rates of 1.0% to < 5.0%

Eye disorders: vision blurred

Gastrointestinal disorders: abdominal pain upper, dyspepsia, abdominal pain, sore throat

General disorders: weakness, pain, feeling hot, influenza like illness, fall, rigors, lethargy, pyrexia, chest pain

Infections and infestations: nasopharyngitis, upper respiratory tract infection, sinusitis, influenza, gastroenteritis viral, urinary tract infection, bronchitis

Investigations: blood creatine phosphokinase increased, weight decreased

Metabolism and nutrition disorders: appetite decreased

Musculoskeletal, connective tissue and bone disorders: arthralgia, back pain, pain in limb, neck pain

Nervous system disorders: tremor, paresthesia, hypoesthesia

Psychiatric disorders: nervousness, anxiety, depression, restlessness

Respiratory, thoracic and mediastinal disorders: sneezing, cough, rhinorrhea, nasal congestion, dyspnea, sinus congestion

Skin and subcutaneous tissue disorders: sweating increased, dermatitis

Vascular disorders: hot flushes, vasodilatation

Adverse events with incidence rates of 0.5% to < 1.0% and serious adverse events reported in at least 2 patients.

Cardiac disorders: palpitations, myocardial infarction

Ear and labyrinth disorders: tinnitus, vertigo

Gastrointestinal disorders: flatulence, toothache, constipation aggravated, appendicitis, pancreatitis

General disorders: feeling jittery, edema lower limb, shivering, joint swelling, malaise, drug withdrawal syndrome, peripheral swelling

Hepato-biliary disorders: cholelithiasis, cholecystitis

Infections and infestations: cellulitis, ear infection, gastroenteritis, pneumonia, viral infection

Injury and poisoning: joint sprain, muscle injury

Investigations: alanine aminotransferase increased, blood pressure increased, aspartate aminotransferase increased, heart rate increased, blood glucose increased, liver function tests abnormal

Musculoskeletal, connective tissue and bone disorders: muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, osteoarthritis aggravated

Nervous system disorders: migraine, sedation, syncope, disturbance in attention, dizziness aggravated

Psychiatric disorders: euphoric mood, irritability, libido decreased, sleep disorder, agitation, disorientation, abnormal dreams

Renal and urinary disorders: difficulty in micturition, urinary frequency, hematuria, dysuria, urinary retention

Respiratory, thoracic and mediastinal disorders: yawning

Skin and subcutaneous tissue disorders: contusion, piloerection, clamminess, night sweats, urticaria

Vascular disorders: hypertension aggravated, hypertension, peripheral ischemia

Post-marketing Experience

The following adverse reactions, not noted above, have been identified during post approval use of tramadol-containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

Eye disorders: miosis, mydriasis

Metabolism and nutrition disorders: Cases of hypoglycemia have been reported very rarely in patients taking tramadol. Most reports were in patients with predisposing risk factors, including diabetes or renal insufficiency, or in elderly patients.

Nervous system disorders: movement disorder, speech disorder

Psychiatric disorders: delirium

Read the entire FDA prescribing information for Ultram ER (Tramadol HCl Extended-Release)

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