Effects and Side Effects Tramadol

In Summary

Commonly reported side effects of tramadol include: pruritus, agitation, anxiety, constipation, diarrhea, hallucination, nausea, tremor, vomiting, and diaphoresis. Other side effects include: insomnia, pruritus, and diaphoresis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to tramadol: oral capsule extended release, oral suspension, oral tablet, oral tablet disintegrating, oral tablet extended release
As well as its needed effects, tramadol may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking tramadol, check with your doctor immediately:
Less common or rare:

• Abdominal or stomach fullness
• abnormal or decreased touch sensation
• blisters under the skin
• bloating
• blood in the urine
• blood pressure increased
• blurred vision
• change in walking and balance
• chest pain or discomfort
• 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 or stomach pain
• heart rate increased
• indigestion
• irregular heartbeat
• loss of memory
• numbness and tingling of the face, fingers, or toes
• numbness, tingling, pain, or weakness in the hands or feet
• pain in the arms, legs, or lower back, especially pain in the calves or heels upon exertion
• pain or discomfort in the arms, jaw, back, or neck
• pains in the 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 the hands or feet
• trouble performing routine tasks
• weak or absent pulses in the legs
• yellow eyes or skin

If any of the following symptoms of overdose occur while taking tramadol, get emergency help immediately:
Symptoms of overdose:

• Change in consciousness
• decreased awareness or responsiveness
• difficulty with breathing
• lack of muscle tone
• lightheadedness
• loss of consciousness
• pinpointed pupils of the eyes
• severe sleepiness
• shortness of breath
• slow or irregular heartbeat
• unusual tiredness

Minor Side Effects

Some tramadol side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:
More common:

• Abdominal or stomach pain
• agitation
• anxiety
• constipation
• cough
• diarrhea
• discouragement
• drowsiness
• dry mouth
• feeling of warmth
• feeling sad or empty
• feeling unusually cold
• fever
• general feeling of discomfort or illness
• headache
• heartburn
• irritability
• itching of the skin
• 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
• weakness

Less common or rare:

• Abnormal dreams
• appetite decreased
• back pain
• bladder pain
• blistering, crusting, irritation, itching, or reddening of the skin
• bloody or cloudy urine
• body aches or pain
• change in hearing
• clamminess
• cold flu-like symptoms
• confusion
• cough producing mucus
• cracked, dry, or scaly skin
• decreased interest in sexual intercourse
• difficult, burning, or painful urination
• difficulty with 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, or warmth on the 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 the limbs
• pain or tenderness around the eyes and cheekbones
• pain, swelling, or redness in the joints
• skin discoloration
• swelling
• swelling of the hands, ankles, feet, or lower legs
• tightness of the chest
• trouble in holding or releasing urine
• trouble with sleeping
• troubled breathing
• weight increased or decreased

Side Effects: Post Treatment

After you stop taking this drug, it is possible that you may still experience side effects that need medical attention. If you notice any of the following side effects check with your doctor immediately:

• Gooseflesh
• high blood pressure
• increased sweating
• increased yawning
• shivering or trembling
• unusually large pupils

For Healthcare Professionals

Applies to tramadol: oral capsule extended release, oral tablet, oral tablet disintegrating, oral tablet extended release

General

The most common adverse reactions include nausea, constipation, dry mouth, somnolence, dizziness, and vomiting.^[Ref]

Psychiatric

CNS stimulation has been reported as a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability, and hallucinations. During clinical trials, tolerance development was mild and the reports of a withdrawal syndrome were rare. Symptoms of a withdrawal syndrome have included: panic attacks, severe anxiety, hallucinations, paraesthesias, tinnitus and unusual CNS symptoms (i.e. confusion, delusions, personalization, derealization, and paranoia).^[Ref]
Very common (10% or more): CNS stimulation (up to 14%)
Common (1% to 10%): Anxiety, euphoria, nervousness, sleep disorder, insomnia, depression, agitation, apathy, depersonalization
Uncommon (0.1% to 1%): Emotional lability
Rare (less than 0.1%): Hallucinations, nightmares, dependency
Very rare (less than 0.01%): Withdrawal syndrome^[Ref]

Hypersensitivity

Rare (less than 0.1%): Anaphylaxis, allergic reactions such as dyspnea, bronchospasm, wheezing, angioneurotic edema, swollen skin^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 40%), constipation (up to 46%), vomiting (up to 17%), dyspepsia (up to 13%)
Common (1% to 10%): Dry mouth, diarrhea, abdominal pain, flatulence, sore throat, gastroenteritis viral
Uncommon (0.1% to 1%): Toothache, appendicitis, pancreatitis^[Ref]

Nervous system

Very common (10% or more): Dizziness (up to 28%), somnolence (up to 25%), headache (up to 32%),
Common (1% to 10%): Confusion, coordination disturbance, tremor, paresthesia, hypoesthesia
Uncommon (0.1% to 1%): Migraine, sedation, syncope, disturbance in attention
Rare (less than 0.1%): Epileptiform seizures
Postmarketing reports: Seizures^[Ref]
Epileptiform seizures primarily occurred following administration of high doses or following concomitant treatment with drugs that lower the seizure threshold or trigger seizures.^[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 11%)
Common (1% to 10%): Sweating, rash, dermatitis
Uncommon (0.1% to 1%): Cellulitis, piloerection, clamminess, urticaria, toxic epidermal necrolysis, Stevens Johnson-syndrome, hair disorder, skin disorder^[Ref]

Genitourinary

Common (1% to 10%): Menopausal symptoms, urinary frequency, urinary retention, urinary tract infection
Uncommon (0.1% to 1%): Difficulty in micturition, hematuria, dysuria, cystitis, sexual function abnormality^[Ref]

Cardiovascular

Very common (10% or more): Flushing (up to 15.8%)
Common (1% to 10%): Vasodilation, postural hypotension, chest pain
Uncommon (0.1% to 1%): Palpitations, myocardial infarction, lower limb edema, peripheral swelling, hypertension, increased heart rate, peripheral ischemia, EKG abnormality, hypotension, tachycardia
Rare (less than 0.1%): Bradycardia^[Ref]

Other

Very common (10% or more): Asthenia (up to 12%)
Common (1% to 10%): Malaise, weakness, pain, feeling hot, influenza like illness, rigors, lethargy, pyrexia
Uncommon (0.1% to 1%): Tinnitus, vertigo, ear infection^[Ref]

Metabolic

Common (1% to 10%): Anorexia, decreased weight, increased blood glucose
Uncommon (0.1% to 1%): Gout
Rare (less than 0.1%): Changes in appetite^[Ref]

Endocrine

Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone secretion^[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, ecchymosis^[Ref]

Hepatic

Uncommon (0.1% to 1%): Cholelithiasis, cholecystitis, ALT and AST increased, abnormal liver function tests^[Ref]

Ocular

Common (1% to 10%): Miosis, visual disturbance, blurred vision
Uncommon (0.1% to 1%): Lacrimation disorder
Frequency not reported: Mydriasis

Renal

Uncommon (0.1% to 1%): blood urea nitrogen increased