Ryzolt

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/18/2021
Ryzolt Side Effects Center

What Is Ryzolt?

Ryzolt (tramadol hydrochloride extended-release tablets) is a narcotic-like pain reliever used to treat moderate to severe pain or severe chronic pain when treatment is needed around the clock. Ryzolt is available in generic form.

What Are Side Effects of Ryzolt?

Possible side effects of Ryzolt include:

  • nausea
  • vomiting
  • dizziness
  • spinning sensation
  • drowsiness
  • flushing
  • blurred vision
  • upset stomach
  • constipation
  • headache
  • sleep problems
  • nervousness, or
  • anxiety

Dosage for Ryzolt

The recommended dosage of Ryzolt is 1 tablet (100 mg) daily.

What Drugs, Substances, or Supplements Interact with Ryzolt?

Ryzolt may interact with pain medications (mixed narcotic agonist-antagonists such as pentazocine, nalbuphine, butorphanol), narcotic antagonists (such as naltrexone), monoamine oxidase inhibitors (MAOIs), and other antidepressants. Do not drive, use machinery, or do any activity that requires alertness while taking Ryzolt. Avoid alcohol.

Ryzolt During Pregnancy or Breastfeeding

Ryzolt should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Ryzolt is excreted in breast milk. Consult your doctor if you are breastfeeding.

Additional Information

Our Ryzolt (tramadol hydrochloride extended-release 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.

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Ryzolt 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 Ryzolt (Tramadol Hydrochloride Extended-Release Tablets)

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Ryzolt Professional Information

SIDE EFFECTS

RYZOLT™ (tramadol hydrochloride extended-release tablets) was administered to a total of 2707 subjects (2406 patients and 301 healthy volunteers) during clinical studies, including four randomized double-blind studies (treatment ≥ 12 weeks) and two open-label long-term studies (treatment up to 12 months) in patients with moderate to severe pain due to osteoarthritis of the knee. A total of 844 patients were exposed to RYZOLT™ (tramadol hydrochloride extended-release tablets) for 12 weeks, 493 patients for 6 months and 243 patients for 12 months. Treatment emergent adverse events increased with dose from 100 mg to 300 mg in the three twelve-week, randomized, double-blind, placebo-controlled studies (Table 2).

Table 2. Percentage of Patients with Incidence of Adverse Events ≥ 2% from Three 12-week Placebo-Controlled Studies (MDT3-002, MDT3-003 and MDT3-005).

ADVERSE EVENTS (MEDRA Preferred Terms) RYZOLT™ Placebo
100 mg N=216 200 mg
N=311
300 mg
N=530
Total*
N=1095
N=668
Nausea 28 (13%) 42 (14%) 76 (14%) 179 (16%) 37 (6%)
Constipation 21 (10%) 36 (12%) 52 (10%) 140 (13%) 26 (4%)
Dizziness 16 (7%) 28 (9%) 52 (10%) 106 (10%) 18 (3%)
Somnolence 11 (5%) 22 (7%) 23 (4%) 77 (7%) 12 (2%)
Vomiting 7 (3%) 16 (5%) 31 (6%) 58 (5%) 4 (1%)
Pruritus 9 (4%) 15 (5%) 18 (3%) 51 (5%) 7 (1%)
Headache 10 (5%) 9 (3%) 15 (3%) 41 (4%) 21 (3%)
Sweating increased 1 (0%) 9 (3%) 14 (3%) 35 (3%) 5 (1%)
Dry mouth 7 (3%) 13 (4%) 6 (1%) 32 (3%) 8 (1%)
Fatigue 6 (3%) 7 (2%) 9 (2%) 26 (2%) 6 (1%)
Anorexia 4 (2%) 4 (1%) 10 (2%) 25 (2%) 2 (0%)
Vertigo 2 (1%) 3 (1%) 6 (1%) 21 (2%) 3 (0%)
Insomnia 2 (1%) 6 (2%) 9 (2%) 18 (2%) 8 (1%)
*Due to the difference in study design of MDT3-005, only the results of the double-blind phase of the study are presented and the dose specific results include maintenance period data only.

The majority of patients who experienced the most common adverse events ( ≥ 5%) reported mild to moderate symptoms. Less than 3% of adverse events were rated as severe. Overall, onset of these adverse events usually occurred within the first two weeks of treatment.

Adverse reactions with an incidence of 1.0% to < 5.0%

Ear and labyrinth disorders: vertigo

Gastrointestinal disorders: abdominal pain, diarrhea, dry mouth, dyspepsia, upper abdominal pain

General disorders: fatigue, weakness

Investigations: weight decreased

Metabolism and nutrition disorders: anorexia

Musculoskeletal and connective tissue disorders: arthralgia

Nervous system disorders: headache, tremor

Psychiatric disorders:anxiety, insomnia

Skin and subcutaneous tissue disorders: pruritus, sweating increased

Vascular disorders: hot flushes

Adverse reactions with an incidence of < 1.0%

Blood and lymphatic system disorders: anemia, thrombocytopenia

Cardiac disorders: bradycardia

Eye disorders: blurred vision, visual disturbance

Gastrointestinal disorders: abdominal discomfort, abdominal distension, abdominal tenderness, change in bowel habit, constipation aggravated, diverticulitis, diverticulum, dyspepsia aggravated, dysphagia, fecal impaction, gastric irritation, gastritis, gastrointestinal hemorrhage, gastrointestinal irritation, gastro-esophageal reflux disease, lower abdominal pain, pancreatitis aggravated, rectal hemorrhage, rectal prolapse, retching

General disorders: asthenia, malaise

Hepatobiliary disorders:biliary tract disorder, cholelithiasis

Immune system disorders: hypersensitivity

Investigations: alanine aminotransferase decreased, alanine aminotransferase increased, aspartate aminotransferase decreased, aspartate aminotransferase increased, blood amylase increased, blood creatinine increased, blood in stool, blood potassium abnormal, blood pressure increased gamma glutamyltransferase increased

Metabolism and nutrition disorders: appetite decreased, dehydration

Nervous system disorders: ataxia, disturbance in attention, dysarthria, gait abnormal, headache aggravated, mental impairment, sedation, seizure, sleep apnea syndrome, syncope, tremor

Psychiatric disorders: abnormal behavior, agitation, anxiety, confusion, depression, emotional disturbance, euphoric mood, indifference, irritability, libido decreased, nervousness, sleep disorder

Renal and urinary disorders: difficulty in micturition, urinary hesitation, urinary retention

Reproductive system and breast disorders: erectile dysfunction, sexual dysfunction,

Respiratory, thoracic and mediastinal disorders: dyspnea

Skin and subcutaneous tissue disorders: allergic dermatitis, cold sweat, dermatitis, night sweats, pallor, generalized pruritus, urticaria

Vascular disorders: flushing, hypertension, hypotension, orthostatic hypotension

Read the entire FDA prescribing information for Ryzolt (Tramadol Hydrochloride Extended-Release Tablets)

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

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