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Ultram ER (Tramadol Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 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).
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



REPORTS OF SUSPECTED ULTRAM ER SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Ultram ER. The information is not vetted and should not be considered as verified clinical evidence.

Possible Ultram ER side effects / adverse reactions in 21 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-11

Patient: 21 year old female

Reactions: Pituitary Tumour Benign, Adrenal Insufficiency

Adverse event resulted in: hospitalization

Suspect drug(s):
Metoclopramide
    Dosage: 3 times a day
    Indication: Product Used FOR Unknown Indication

Ultram ER
    Dosage: 3 doses a day

Ultram ER
    Dosage: once a day
    Indication: Abdominal Pain

Other drugs received by patient: Ibuprofen; Sumatriptan Succinate; Omeprazole; Cyclizine



See index of all Ultram ER side effect reports >>

Drug label data at the top of this Page last updated: 2012-03-20

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