Ryzolt
FDA: 2 More NECC Drugs Contaminated »
"Nov. 1, 2012 -- Two more drugs made by the New England Compounding Center (NECC) are crawling with various kinds of bacteria, FDA tests reveal.
The NECC is the Massachusetts compounding pharmacy whose drugs are the likely source of th"...
Ryzolt
Ryzolt Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
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. This medication is available in generic form. Possible side effects include nausea, vomiting, dizziness, drowsiness, flushing, blurred vision, constipation, or sleep problems.
The recommended dosage of Ryzolt is 1 tablet (100 mg) daily. 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 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.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Ryzolt in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. 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) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ryzolt FDA Prescribing Information: Side Effects
(Adverse Reactions)
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) »
Additional Ryzolt Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Chronic Pain/Back Pain
Find tips and advances in treatment.
Updated & New
