Qdolo

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/24/2021
Qdolo Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What is Qdolo and how is it used?

Qdolo (tramadol hydrochloride) is an opioid agonist used in adults to manage pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

What Are Side Effects of Qdolo?

Side effects of Qdolo include:

As an opioid, Qdolo exposes users to the risks of addiction, abuse, and misuse. Withdrawal symptoms may occur if you suddenly stop taking Qdolo.

Dosage for Qdolo

The starting dose of Qdolo is 25 mg/day, titrated in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg four times a day). Thereafter the total daily dose may be increased by 50 mg as tolerated every 3 days to reach 200 mg /day (50 mg four times a day). After titration, Qdolo 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.

Qdolo In Children

The safety and effectiveness of Qdolo in pediatric patients have not been established.

Life-threatening respiratory depression and death have occurred in children who received tramadol. Children with sleep apnea may be particularly sensitive to the respiratory depressant effects of tramadol. Because of the risk of life-threatening respiratory depression and death Qdolo is contraindicated for all children younger than 12 years of age.

Qdolo is contraindicated for postoperative management in pediatric patients younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of Qdolo in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of tramadol unless the benefits outweigh the risks. Risk factors include conditions associated with hypoventilation such as postoperative status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, and concomitant use of other medications that cause respiratory depression.

What Drugs, Substances, or Supplements Interact with Qdolo?

Qdolo may interact with other medicines such as:

  • quinidine,
  • fluoxetine,
  • paroxetine,
  • bupropion,
  • macrolide antibiotics,
  • azole antifungal agents,
  • protease inhibitors,
  • rifampin,
  • carbamazepine,
  • phenytoin,
  • benzodiazepines and other sedatives/hypnotics,
  • anxiolytics,
  • tranquilizers,
  • muscle relaxants,
  • general anesthetics,
  • antipsychotics,
  • other opioids,
  • alcohol,
  • selective serotonin reuptake inhibitors (SSRIs),
  • serotonin and norepinephrine reuptake inhibitors (SNRIs),
  • tricyclic antidepressants (TCAs),
  • triptans,
  • 5-HT3 receptor antagonists,
  • drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol),
  • certain muscle relaxants (i.e., cyclobenzaprine, metaxalone),
  • monoamine oxidase inhibitors (MAOIs),
  • butorphanol,
  • nalbuphine,
  • pentazocine,
  • buprenorphine,
  • diuretics,
  • anticholinergic drugs,
  • digoxin, and
  • warfarin

Tell your doctor all medications and supplements you use.

Qdolo During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Qdolo; it may harm a fetus. Prolonged use of opioid analgesics such as Qdolo during pregnancy may cause neonatal opioid withdrawal syndrome. Qdolo passes into breast milk. Qdolo is not recommended in nursing mothers because its safety in infants and newborns has not been well studied. Withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breastfeeding is stopped.

Additional Information

Our Qdolo (tramadol hydrochloride) Oral Solution C-IV Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Qdolo Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Tramadol can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
  • a slow heart rate or weak pulse;
  • a light-headed feeling, like you might pass out;
  • seizure (convulsions); or
  • low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious breathing problems may be more likely in older adults and people who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

  • constipation, nausea, vomiting, stomach pain;
  • dizziness, drowsiness, tiredness;
  • headache; or
  • itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Qdolo (Tramadol Hydrochloride Oral Solution)

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Qdolo Professional Information

SIDE EFFECTS

The following serious adverse reactions are described, or described in greater detail, in other sections:

  • Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
  • Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
  • Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children [see WARNINGS AND PRECAUTIONS]
  • Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
  • Interactions with Benzodiazepines or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
  • Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Suicide [see WARNINGS AND PRECAUTIONS]
  • Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
  • Severe Hypotension [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Withdrawal [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tramadol hydrochloride was administered to 550 patients during the double-blind or open-label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older. Table 1 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions listed in the table are felt to be probably related to tramadol hydrochloride administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication. The overall incidence rates of adverse experiences in these trials were similar for tramadol hydrochloride and the active control groups, TYLENOL with Codeine #3 (acetaminophen 300 mg with codeine phosphate 30 mg), and aspirin 325 mg with codeine phosphate 30 mg, however, the rates of withdrawals due to adverse events appeared to be higher in the tramadol hydrochloride groups.

Table 1: Cumulative Incidence of Adverse Reactions for Tramadol HCl Tablets in Chronic Trials of Nonmalignant Pain (N=427)

Up to 7 DaysUp to 30 DaysUp to 90 Days
Dizziness/Vertigo26%31%33%
Nausea24%34%40%
Constipation24%38%46%
Headache18%26%32%
Somnolence16%23%25%
Vomiting9%13%17%
Pruritus8%10%11%
CNS Stimulation*7%11%14%
Asthenia6%11%12%
Sweating6%7%9%
Dyspepsia5%9%13%
Dry Mouth5%9%10%
Diarrhea5%6%10%
*CNS Stimulation is a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability and hallucinations

Incidence 1% To Less Than 5% Possibly Causally Related

The following lists adverse reactions that occurred with an incidence of 1% to less than 5% in clinical trials, and for which the possibility of a causal relationship with tramadol hydrochloride exists.

Body as a Whole: Malaise.

Cardiovascular: Vasodilation.

Central Nervous System: Anxiety, Confusion, Coordination disturbance, Euphoria, Miosis, Nervousness, Sleep disorder.

Gastrointestinal: Abdominal pain, Anorexia, Flatulence.

Musculoskeletal: Hypertonia.

Skin: Rash.

Special Senses: Visual disturbance.

Urogenital: Menopausal symptoms, Urinary frequency, Urinary retention.

Incidence Less Than 1%, Possibly Causally Related

The following lists adverse reactions that occurred with an incidence of less than 1% in clinical trials of tramadol and/or reported in postmarketing experience with tramadol-containing products.

Body as a Whole: Accidental injury, Allergic reaction, Anaphylaxis, Death, Suicidal tendency, Weight loss, Serotonin syndrome (mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma).

Cardiovascular: Orthostatic hypotension, Syncope, Tachycardia.

Central Nervous System: Abnormal gait, Amnesia, Cognitive dysfunction, Depression, Difficulty in concentration, Hallucinations, Paresthesia, Seizure, Tremor.

Respiratory: Dyspnea.

Skin: Stevens-Johnson syndrome/Toxic epidermal necrolysis, Urticaria, Vesicles.

Special Senses: Dysgeusia.

Urogenital: Dysuria, Menstrual disorder.

Other Adverse Experiences, Causal Relationship Unknown

A variety of other adverse events were reported infrequently in patients taking tramadol hydrochloride during clinical trials and/or reported in postmarketing experience. A causal relationship between tramadol hydrochloride and these events has not been determined. However, the most significant events are listed below as alerting information to the physician.

Cardiovascular: Abnormal ECG, Hypertension, Hypotension, Myocardial ischemia, Palpitations, Pulmonary edema, Pulmonary embolism.

Central Nervous System: Migraine.

Gastrointestinal: Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure.

Laboratory Abnormalities: Creatinine increase, Elevated liver enzymes, Hemoglobin decrease, Proteinuria.

Sensory: Cataracts, Deafness, Tinnitus.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of tramadol hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Serotonin Syndrome

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Androgen Deficiency

Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

QT prolongation/Torsade De Pointes

Cases of QT prolongation and/or torsade de pointes have been reported with tramadol use. Many of these cases were reported in patients taking another drug labeled for QT prolongation, in patients with a risk factor for QT prolongation (e.g., hypokalemia), or in the overdose setting.

Eye disorders - mydriasis

Metabolism and nutrition disorders - Cases of hypoglycemia have been reported very rarely in patients taking tramadol. Most reports were in patients with predisposing risk factors, including diabetes or renal insufficiency, or in elderly patients.

Nervous system disorders - movement disorder, speech disorder

Psychiatric disorders - delirium

Read the entire FDA prescribing information for Qdolo (Tramadol Hydrochloride Oral Solution)

© Qdolo Patient Information is supplied by Cerner Multum, Inc. and Qdolo Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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