Note: This document contains side effect information about tramadol. Some dosage forms listed on this page may not apply to the brand name Qdolo.
Applies to tramadol: oral conventional tablets, oral extended-release tablets, oral extended-release capsules.
Warning
Special Alerts:
- FDA drug safety communication (4/13/2023):500 As part of its ongoing efforts to address the nation’s opioid crisis, FDA is requiring several updates to the prescribing information of opioid pain medicines. The changes are being made to provide additional guidance for safe use of these drugs while also recognizing the important benefits when used appropriately. The changes apply to both immediate-release (IR) and extended-release/long-acting preparations (ER/LA).
- Updates to the IR opioids state that these drugs should not be used for an extended period unless the pain remains severe enough to require an opioid pain medicine and alternative treatment options are insufficient, and that many acute pain conditions treated in the outpatient setting require no more than a few days of an opioid pain medicine.
- Updates to the ER/LA opioids recommend that these drugs be reserved for severe and persistent pain requiring an extended period of treatment with a daily opioid pain medicine and for which alternative treatment options are inadequate.
- A new warning is being added about opioid-induced hyperalgesia (OIH) for both IR and ER/LA opioid pain medicines. This includes information describing the symptoms that differentiate OIH from opioid tolerance and withdrawal.
- Information in the boxed warning for all IR and ER/LA opioid pain medicines will be updated and reordered to elevate the importance of warnings concerning life-threatening respiratory depression, and risks associated with using opioid pain medicines in conjunction with benzodiazepines or other medicines that depress the central nervous system (CNS).
- Other changes will also be required in various other sections of the prescribing information to educate clinicians, patients, and caregivers about the risks of these drugs.
REMS:
FDA approved a REMS for tramadol to ensure that the benefits outweigh the risk. The REMS may apply to one or more preparations of tramadol and consists of the following: medication guide and elements to assure safe use. See the FDA REMS page ([Web]).
Side effects include:
Asthenia, CNS stimulation, constipation, diarrhea, dizziness, dry mouth, dyspepsia, flushing, headache, nausea, pruritus, somnolence, anorexia, sweating, vomiting.
For Healthcare Professionals
Applies to tramadol: oral capsule extended release, oral liquid, 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
Epileptiform seizures primarily occurred following administration of high doses or following concomitant treatment with drugs that lower the seizure threshold or trigger seizures.
Serotonin syndrome has been reported during concomitant use of opioids with serotonergic drugs.[Ref]
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
Opioids:
Postmarketing reports: Serotonin syndrome[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
Postmarketing reports: QT prolongation/torsade de pointes[Ref]
Reports of QT prolongation and/or torsade de pointes have been received. In many cases, patients were taking another drug associated with QT prolongation, had risk factors for QT prolongation such as hypokalemia, or in the overdose setting.[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
Severe hyponatremia and/or SIADH have been reported, most often in females over 65 years old, and within the first week of therapy.[Ref]
Common (1% to 10%): Anorexia, decreased weight, increased blood glucose
Uncommon (0.1% to 1%): Gout
Rare (less than 0.1%): Changes in appetite
Postmarketing reports: Hyponatremia[Ref]
Endocrine
Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone secretion
Opioids:
Postmarketing reports: Adrenal insufficiency; androgen deficiency[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[Ref]
Renal
Uncommon (0.1% to 1%): blood urea nitrogen increased[Ref]
Musculoskeletal
Common (1% to 10%): Hypertonia, arthralgia, back pain, limb pain, neck pain, muscle cramps, muscle spasms, joint stiffness, muscle twitching, myalgia, aggravated osteoarthritis
Uncommon (0.1% to 1%): Joint swelling, joint sprain, muscle injury, leg cramps
Rare (less than 0.1%): Involuntary muscle contractions[Ref]
