Tramadol
Frequent Tramadol Side Effects
Tramadol is generally well tolerated, and side effects are usually transient.
Commonly reported side effects include nausea, constipation, dizziness, headache, drowsiness, vomiting, weakness, incoordination, vomiting, stomach upset, anxiety, irritability, dry mouth, or increased sweating. If any of these effects persist or worsen, inform your doctor.
ULTRAM ER (tramadol) 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 nonmalignant pain .
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 (tramadol) | 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) |
| 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) |
Infrequent Tramadol Side Effects
Less commonly reported side effects include itching, sweating, dry mouth, diarrhea, rash, visual disturbances, and vertigo. Some patients who received tramadol have reported seizures. Abrupt withdrawal of tramadol may result in anxiety, sweating, insomnia, rigors, pain, nausea, diarrhea, tremors, and hallucinations.
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
Dangerous Tramadol Side Effects
Notify your doctor if you develop any of these serious effects while taking this medication: chest pain, rapid heart rate, skin rash or itching, mental confusion, disorientation, seizures, tingling of the hands or feet, trouble breathing. In the unlikely event you have a serious allergic reaction to this drug, seek immediate medical attention. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, breathing trouble. If you notice other effects not listed above, contact your doctor or pharmacist.
