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Ultram ER

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Ultram ER

Ultram ER Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Ultram ER (tramadol extended-release) is a narcotic-like pain reliever that is used to treat moderate to severe pain. Tramadol extended-release is used to treat moderate to severe chronic pain when treatment is needed around the clock. Ultram ER is taken orally in tablet form. Possible side effects can include nausea, vomiting, dizziness, drowsiness, flushing, blurred vision, constipation, and sleep problems.

There are no adequate and well-controlled studies of Ultram ER in pregnant women. This medication should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Neonatal seizures, neonatal withdrawal syndrome, fetal death and stillbirth have been reported with tramadol immediate-release products. Tramadol extended-release is not recommended for obstetrical preoperative medication or for post-delivery analgesia in nursing mothers because its safety in infants and newborns has not been studied.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ultram ER in Detail - Patient Information: Side Effects

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Ultram ER Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, constipation, sweating, trouble sleeping, dry mouth, fatigue, loss of appetite, lightheadedness, dizziness, drowsiness, or headache may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.

Get medical help right away if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Ultram ER (Tramadol HCl Extended-Release)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ultram ER FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

ULTRAM ER (tramadol hcl extended-release) 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 non-malignant 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).

Sweating
MedDRA Preferred Term ULTRAMER Placebo
(N=406)
n (%)
100 mg
(N=403)
n (%)
200 mg
(N=400)
n (%)
300 mg
(N=400)
n (%)
400 mg
(N=202)
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)
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

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

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Ultram ER - User Reviews

Ultram ER User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Ultram ER sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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