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.
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:
Seek medical attention right away if any of these SEVERE side effects occur when using Ultram:Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; indigestion; mild itching; nausea; trouble sleeping; vomiting; weakness.
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; confusion; difficult or painful urination; disorientation; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or light-headedness; severe nausea, vomiting, or diarrhea; severe or persistent headache; slow or shallow breathing; suicidal thoughts or behaviors; tremor; vision problems.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
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:
Seek medical attention right away if any of these SEVERE side effects occur when using Ultram ER Extended-Release Tablets:Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; indigestion; mild itching; nausea; trouble sleeping; vomiting; weakness.
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; confusion; difficult or painful urination; disorientation; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or light-headedness; severe nausea, vomiting, or diarrhea; severe or persistent headache; slow or shallow breathing; suicidal thoughts or behaviors; tremor; vision problems.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopUltram Side Effects - for the Professional
Ultram
Ultram® was administered to 550 patients during the double-blind or open-label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older. Table 2 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions listed in the table are felt to be probably related to Ultram® administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication. The overall incidence rates of adverse experiences in these trials were similar for Ultram® and the active control groups, TYLENOL® with Codeine #3 (acetaminophen 300 mg with codeine phosphate 30 mg), and aspirin 325 mg with codeine phosphate 30 mg, however, the rates of withdrawals due to adverse events appeared to be higher in the Ultram® groups.
| Up to 7 Days | Up to 30 Days | Up to 90 Days | |
|---|---|---|---|
|
|||
| Dizziness/Vertigo | 26% | 31% | 33% |
| Nausea | 24% | 34% | 40% |
| Constipation | 24% | 38% | 46% |
| Headache | 18% | 26% | 32% |
| Somnolence | 16% | 23% | 25% |
| Vomiting | 9% | 13% | 17% |
| Pruritus | 8% | 10% | 11% |
| "CNS Stimulation"* | 7% | 11% | 14% |
| Asthenia | 6% | 11% | 12% |
| Sweating | 6% | 7% | 9% |
| Dyspepsia | 5% | 9% | 13% |
| Dry Mouth | 5% | 9% | 10% |
| Diarrhea | 5% | 6% | 10% |
Incidence 1% to less than 5% possibly causally related: the following lists adverse reactions that occurred with an incidence of 1% to less than 5% in clinical trials, and for which the possibility of a causal relationship with Ultram® exists.
Body as a Whole: Malaise.
Cardiovascular: Vasodilation.
Central Nervous System: Anxiety, Confusion, Coordination disturbance, Euphoria, Miosis, Nervousness, Sleep disorder.
Gastrointestinal: Abdominal pain, Anorexia, Flatulence.
Musculoskeletal: Hypertonia.
Skin: Rash.
Special Senses: Visual disturbance.
Urogenital: Menopausal symptoms, Urinary frequency, Urinary retention.
Incidence less than 1%, possibly causally related: the following lists adverse reactions that occurred with an incidence of less than 1% in clinical trials and/or reported in post-marketing experience.
Body as a Whole: Accidental injury, Allergic reaction, Anaphylaxis, Death, Suicidal tendency, Weight loss, Serotonin syndrome (mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma).
Cardiovascular: Orthostatic hypotension, Syncope, Tachycardia.
Central Nervous System: Abnormal gait, Amnesia, Cognitive dysfunction, Depression, Difficulty in concentration, Hallucinations, Paresthesia, Seizure. Tremor.
Respiratory: Dyspnea.
Skin: Stevens-Johnson syndrome/Toxic epidermal necrolysis, Urticaria, Vesicles.
Special Senses: Dysgeusia.
Urogenital: Dysuria, Menstrual disorder.
Other adverse experiences, causal relationship unknown: A variety of other adverse events were reported infrequently in patients taking Ultram® during clinical trials and/or reported in post-marketing experience. A causal relationship between Ultram® and these events has not been determined. However, the most significant events are listed below as alerting information to the physician.
Cardiovascular: Abnormal ECG, Hypertension, Hypotension, Myocardial ischemia, Palpitations, Pulmonary edema, Pulmonary embolism.
Central Nervous System: Migraine, Speech disorders.
Gastrointestinal: Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure.
Laboratory Abnormalities: Creatinine increase, Elevated liver enzymes, Hemoglobin decrease, Proteinuria.
Sensory: Cataracts, Deafness, Tinnitus.
TopSide Effects by Body System - for Healthcare Professionals
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.
Metabolic
Metabolic side effects including hyponatremia have been reported.
TopMore Ultram resources
- Ultram Monograph (AHFS DI)
- Ultram Prescribing Information (FDA)
- Ultram MedFacts Consumer Leaflet (Wolters Kluwer)
- Ultram Advanced Consumer (Micromedex) - Includes Dosage Information
- Ultram Consumer Overview
- ConZip Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)
- ConZip Prescribing Information (FDA)
- Rybix ODT Orally Disintegrating Tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Rybix ODT Prescribing Information (FDA)
- Ryzolt Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)
- Ryzolt Prescribing Information (FDA)
- Ryzolt Consumer Overview
- Ultram ER Prescribing Information (FDA)
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