Ryzolt Side Effects

Generic Name: tramadol,tramadol hydrochloride

Please note - some side effects for Ryzolt may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Ryzolt - for the Consumer

Ryzolt Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ryzolt Extended-Release Tablets:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; indigestion; mild itching; nausea; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Ryzolt Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); agitation; chest pain; confusion; difficult or painful urination; disorientation; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or light-headedness; severe nausea, vomiting, or diarrhea; severe or persistent headache; slow or shallow breathing; suicidal thoughts or behaviors; tremor; vision problems.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Ryzolt Side Effects - for the Professional

Ryzolt

Ryzolt®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®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).

* 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.
Adverse Events (MEDRA Preferred terms)	Ryzolt®				Placebo
	100 mg	200 mg	300 mg	Total*
	N=216	N=311	N=530	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%)

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

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Side Effects by Body System - for Healthcare Professionals

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 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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