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Ultram Side Effects

Please note - some side effects for Ultram may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).


Side Effects of Ultram - for the Consumer

Ultram

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ultram:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Ultram:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; chest pain; difficult or painful urination; disorientation; fainting; hallucinations; irregular heartbeat; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or lightheadedness.

Ultram ER Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ultram ER Extended-Release Tablets:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Ultram ER Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; chest pain; difficult or painful urination; disorientation; fainting; hallucinations; irregular heartbeat; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or lightheadedness.

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Ultram Side Effects - for the Professional

Ultram

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 non-malignant pain. A total of 901 patients were 65 years or older. The frequency of adverse events generally7 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.

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).
Ultram ER Placebo
MedDRA Preferred Term 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

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Side Effects by Body System

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.

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More resources:

Drugs.com Ryzolt

Drugs.com Ultram

PDR Ultram

MedFacts Ultram

MedFacts Ryzolt Extended-Release Tablets

Micromedex Ultram - Includes detailed dosage instructions.

FDA Ultram

FDA Ryzolt

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