Rybix ODT Side Effects

Generic name: tramadol

Note: This document contains side effect information about tramadol. Some of the dosage forms listed on this page may not apply to the brand name Rybix ODT.

Some side effects of Rybix ODT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

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

Get emergency medical help if you have any of these signs of an allergic reaction while taking tramadol (the active ingredient contained in Rybix ODT) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tramadol and call your doctor at once if you have any of these serious side effects:

• agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

• seizure (convulsions);

• a red, blistering, peeling skin rash; or

• shallow breathing, weak pulse.

Less serious side effects of tramadol may include:

• dizziness, spinning sensation;

• constipation, upset stomach;

• headache;

• drowsiness; or

• feeling nervous or anxious.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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

Gastrointestinal

Gastrointestinal side effects are common. Nausea and constipation occur within the first 90 days of therapy in 40% and 46% of treated patients, respectively. Vomiting, diarrhea, dyspepsia, anorexia, flatulence, abdominal pain, and dry mouth have also been reported.

Nervous system

Seizures have been reported in patients receiving the normal recommended dose. The risk for seizures is increased with doses above the recommended range.

Nervous system side effects occur frequently. Dizziness, headache, and somnolence have been reported in more than 25% of treated patients during the first three months of therapy. CNS stimulation, including nervousness, anxiety, tremor, agitation, euphoria, emotional lability and hallucinations, has also been reported. Confusion, sleep disorders, and coordination disturbances have been reported in less than 5% of patients. Seizures have been reported in over 200 cases. Cases of long-lasting delirium have been reported in two elderly patients. A case of serotonin syndrome triggered by tramadol has also been reported.

Dermatologic

Dermatologic side effects including pruritus (11%) have been reported. Rash and urticaria have occurred rarely.

Genitourinary

Genitourinary side effects including urinary retention and urinary frequency have been reported in less than 5% of treated patients.

Cardiovascular

Cardiovascular side effects including tachycardia and orthostatic hypotension have been reported rarely.

Hypersensitivity

The use of tramadol (the active ingredient contained in Rybix ODT) is contraindicated for patients with a history of allergy to any opioid.

Hypersensitivity side effects including anaphylactoid reactions have been reported after first doses of tramadol as well as in patients with a documented history of codeine allergy. Angioedema has been reported rarely.

Other

Other side effects including withdrawal symptoms and, rarely, auditory hallucinations have been reported. A case of vocal cord closure has also been reported.

Metabolic

Metabolic side effects including hyponatremia have been reported.

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