Rybix ODT

Last reviewed on RxList: 12/14/2018
Rybix ODT Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/14/2018

Rybix ODT (tramadol hydrochloride) is indicated for the management of moderate to moderately severe pain in adults. Common side effects of Rybix ODT include:

A dose of Rybix ODT 50 mg to 100 mg can be administered as needed for pain relief every 4 to 6 hours, not to exceed 400 mg per day. Rybix ODT may interact with quinidine, fluoxetine, paroxetine, amitriptyline, ketoconazole, erythromycin, SSRIs/SNRIs, monoamine oxidase inhibitors (MAOIs), alpha-blockers, triptans, linezolid, lithium, St. John's wort, carbamazepine, quinidine, rifampin, digoxin, and warfarin. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Rybix ODT; it may harm a fetus. Rybix ODT passes into breast milk. Breastfeeding while using Rybix ODT is not recommended. Withdrawal symptoms may occur if you suddenly stop taking Rybix ODT.

Our Rybix ODT (tramadol hydrochloride) Orally Disintegrating Tablets 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.

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Rybix ODT 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 Rybix ODT (Tramadol Hydrochloride Orally Disintegrating Tablets)

SLIDESHOW

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Rybix ODT Professional Information

SIDE EFFECTS

An orally swallowed immediate release tablet of tramadol 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 2 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 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 and the active control groups, 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 groups.

Table 2: Cumulative Incidence of Adverse Reactions for Tramadol Hydrochloride in Chronic Trials of Nonmalignant Pain (N = 427)

  Up to 7 Days Up to 30 Days Up to 90 Days
Dizziness/Vertigo 26% 31% 33%
Nausea 24% 34% 40%
Constipation 24% 38% 46%
Headache 18% 26% 32%
Somnolence 16% 23% 25%
Vomiting 9% 13% 17%
Pruritus 8% 10% 11%
“CNS Stimulation”1 7% 11% 14%
Asthenia 6% 11% 12%
Sweating 6% 7% 9%
Dyspepsia 5% 9% 13%
Dry Mouth 5% 9% 10%
Diarrhea 5% 6% 10%
1 “CNS Stimulation” is a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional liability, and hallucinations.

Incidence 1% To Less Than 5%, Possibly Casually 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 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 and/or reported in post-marketing experience.

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 (see WARNINGS), 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 during clinical trials and/or reported in post-marketing experience. A causal relationship between tramadol 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, Speech disorders.

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

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

Sensory: Cataracts, Deafness, Tinnitus.

Read the entire FDA prescribing information for Rybix ODT (Tramadol Hydrochloride Orally Disintegrating Tablets)

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

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