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Tramadol Side Effects

Tramadol SIDE EFFECTS:  Drowsiness, constipation, nausea, diarrhea, dizziness, or dry mouth may occur. If any of these effects persist or worsen, notify your doctor. Tell your doctor immediately if any of these serious side effects occur: loss of appetite, unusual weight loss, trouble sleeping, increased sweating, or trouble urinating (males only). Tell your doctor immediately if any of these unlikely but serious side effects occur: vomiting. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: chest pain, severe headache, blurred vision, ringing in the ear(s), fainting, irregular heartbeat, seizures, trouble swallowing, black stool, mental/mood changes. If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams per day (4000 milligrams). If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. Tell your doctor immediately if you have any of the following symptoms of liver damage: severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, severe dizziness, itching, swelling, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

TRAMADOL PRECAUTIONS: Tell your doctor your medical history, especially of: liver disease, kidney problems, seizure disorder, drug or alcohol dependency, lung/breathing problems, any allergies (especially to codeine). This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Avoid alcoholic beverages. This product contains acetaminophen. Acetaminophen may cause liver damage. Daily use of alcohol, especially when combined with acetaminophen, may increase your risk for liver damage. Check with your doctor or pharmacist for more information. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Side Effects of Tramadol

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following symptoms of overdose occur:

  • Change in consciousness;  chest pain or discomfort;  convulsions (seizures);  decreased awareness or responsiveness;  difficulty in breathing;  dizziness or fainting;  lack of muscle tone;  lightheadedness ;  loss of consciousness;  pinpointed pupils of the eyes;  severe sleepiness ;  shortness of breath;  slow or irregular heartbeat;  unusual tiredness 

Also, check with your doctor as soon as possible if any of the following side effects occur:

  • Less common or rare
    • Abdominal fullness;  abnormal or decreased touch sensation;  blisters under the skin;  bloating;  blood in urine;  blood pressure increased;  blurred vision ;  chest pain or discomfort;  change in walking and balance;  chills;  convulsions (seizures);  darkened urine ;  difficult urination;  dizziness or lightheadedness when getting up from a lying or sitting position ;  fainting;  fast heartbeat ;  frequent urge to urinate;  gaseous abdominal pain;  heart rate increased;  indigestion;  irregular heartbeat;  loss of memory;  numbness and tingling of face, fingers, or toes;  numbness, tingling, pain, or weakness in hands or feet;  pain in arms, legs, or lower back, especially pain in calves and/or heels upon exertion;  pain or discomfort in arms, jaw, back or neck;  pains in stomach, side, or abdomen, possibly radiating to the back;  pale bluish-colored or cold hands or feet;  recurrent fever;  seeing, hearing, or feeling things that are not there;  severe cramping;  severe nausea;  severe redness, swelling, and itching of the skin;  shortness of breath;  sweats;  trembling and shaking of hands or feet;  trouble performing routine tasks;  weak or absent pulses in legs;  yellow eyes or skin 

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

  • More common
    • Abdominal or stomach pain;  agitation ;  anxiety;  constipation ;  cough;  diarrhea;  discouragement;  dizziness;  drowsiness;  dry mouth;  feeling of warmth;  feeling sad or empty ;  feeling unusually cold;  fever;  general feeling of discomfort or illness;  headache;  heartburn;  itching of the skin;  irritability;  joint pain;  loss of appetite;  loss of interest or pleasure;  loss of strength or weakness;  muscle aches and pains;  nausea;  nervousness;  redness of the face, neck, arms and occasionally, upper chest;  restlessness;  runny nose;  shivering;  skin rash;  sleepiness or unusual drowsiness;  sore throat;  stuffy nose;  sweating;  tiredness;  trouble concentrating;  unusual feeling of excitement;  unusual tiredness or weakness;  vomiting;  weakness 

  • Less common or rare
    • Abnormal dreams;  appetite decreased ;  back pain;  bladder pain ;  blistering, crusting, irritation, itching, or reddening of skin;  bloody or cloudy urine;  body aches or pain;  change in hearing;  clamminess;  cold flu-like symptoms;  confusion;  cough producing mucus;  cracked, dry, scaly skin;  decreased interest in sexual intercourse;  difficult, burning, or painful urination;  difficulty breathing ;  difficulty in moving;  disturbance in attention;  ear congestion;  ear drainage;  earache or pain in ear ;  excessive gas;  fall;  false or unusual sense of well-being;  feeling hot;  feeling jittery;  flushing or redness of the skin;  general feeling of bodily discomfort;  goosebumps;  headache, severe and throbbing;  hoarseness;  hot flashes;  inability to have or keep an erection;  itching, pain, redness, swelling, tenderness, warmth on skin;  joint sprain;  joint stiffness;  joint swelling;  loss in sexual ability, desire, drive, or performance;  loss of voice;  lower back or side pain;  muscle aching or cramping;  muscle injury ;  muscle pain or stiffness;  muscle spasms or twitching;  nasal congestion;  neck pain;  night sweats;  pain;  pain in limb;  pain or tenderness around eyes and cheekbones;  pain, swelling, or redness in joints;  skin discoloration ;  swelling;  swelling of hands, ankles, feet, or lower legs;  tightness of chest;  trouble in holding or releasing urine;  troubled breathing;  trouble in sleeping ;  weight increased or decreased 

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice any of the following side effects:

  • Anxiety;  body aches;  diarrhea;  fast heartbeat;  fever, runny nose, or sneezing;  gooseflesh;  high blood pressure;  increased sweating ;  increased yawning;  loss of appetite;  nausea or vomiting;  nervousness, restlessness or irritability;  shivering or trembling;  stomach cramps;  trouble in sleeping;  unusually large pupils;  weakness 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Tramadol - four years' experience

Tramadol (Tramal) is a centrally acting analgesic which has been available in Australia for four years. Although chemically unrelated to the opiates, it stimulates opioid receptors and inhibits noradrenaline and serotonin uptake.

ADRAC has received 354 reports in association with tramadol. The most common reactions include nausea, vomiting, sweating, dizziness, rash, tremor and headache. The more serious adverse reactions reported are presented in Table 1.

Table 1: More serious adverse reactions with tramadol

Reaction

No. of reports

Confusion

36

Hallucinations

30

Convulsions

26

Serotonin syndrome

20

Increase in blood pressure

14

Hypersensitivity reactions

12

Hepatic reactions

10

Warfarin interaction

5

For the cases of convulsions, the median time to onset was 2 (range 1-19) days. Tramadol was the only suspected drug in 11 cases, but in 14 other cases the patient was taking additional drugs which may lower the seizure threshold, including propofol, bupropion, hydrocortisone, morphine, and tricyclic anti-depressants. One patient had a history of epilepsy, and was also taking carbamazepine and phenytoin.

Tramadol may cause serotonin syndrome, particularly when it is used at high doses or in combination with other agents increasing serotonin levels.1 In 16 of the 20 cases, the patient was taking potentially interacting medicines including moclobemide, SSRIs, tricyclic antidepressants, sibutramine and St John's wort.

Increases in hepatic enzymes were reported in 10 cases. One patient developed hepatic failure and died. All times to onset were short (range 1-19 days; median 9 days).

Tramadol may interact with warfarin to decrease prothrombin activity, although the mechanism is unknown.2 ADRAC has received five reports of this interaction. Monitoring of INR should be considered when tramadol is started in patients taking warfarin.

Although tramadol acts on opioid receptors, dependence and abuse appear to be rare.3 ADRAC has, however, received 11 reports of withdrawal symptoms with tramadol.

The use of tramadol has increased rapidly, with PBS dispensings of oral formulations rising from 23,000 in 2000 to 580,000 in 2001 and over 1,100,000 in 2002. Prescribers should be alert to the more serious adverse reactions, especially those of a neuropsychiatric nature.

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