"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
- Clinician Information:
ConZip Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
ConZip (tramadol hydrochloride) is an analgesic used to treat moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time. Common side effects include nausea, vomiting, constipation, sweating, trouble sleeping, dry mouth, fatigue, loss of appetite, lightheadedness, dizziness, drowsiness, or headache.
ConZip is an extended-release formulation intended for once a day dosing, starting at an initial dose of 100 mg once daily and adjusted as necessary by 100 mg increments every five days to achieve a balance between relief of pain and tolerability. ConZip may interact with antidepressants, MAOIs, neuroleptics, quinidine, ketoconazole, antibiotics, lithium, St. John's Wort, triptans, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers, sedative hypnotics, digoxin, warfarin, carbamazepine, or rifampin. Tell your doctor all medications and supplements you use. During pregnancy, ConZip should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our ConZip (tramadol hydrochloride) 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 Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
ConZip FDA Prescribing Information: Side Effects
The following serious or otherwise important adverse reactions are described in greater detail, in other sections:
- Seizure risk [see WARNINGS AND PRECAUTIONS]
- Suicide risk [see WARNINGS AND PRECAUTIONS]
- Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
- Anaphylactoid and allergic reactions [see WARNINGS AND PRECAUTIONS]
- Respiratory depression [see WARNINGS AND PRECAUTIONS]
- Withdrawal symptoms [see WARNINGS AND PRECAUTIONS]
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
ConZip™ capsules were administered to a total of 1987 patients in clinical trials. These included four double-blind and one long-term, open-label study in patients with osteoarthritis of the hip and knee. A total of 812 patients were 65 years or older. Adverse reactions with doses from 100 mg to 300 mg in the four pooled, randomized, doubleblind, placebo-controlled studies in patients with chronic non-malignant pain are presented in the following table (see Table 1).
Table 1: Incidence (%) of patients with adverse
reaction rates ≥ 5% from four doubleblind, placebo controlled studies in
patients with moderate to moderately severe chronic pain by dose (N=1917).
|Headache||99 (23.1)||96 (22.1)||200 (19.0)||128 (19.8)|
|Nausea||69 (16.1)||93 (21.4)||265 (25.1)||37 (5.7)|
|Somnolence||50 (11.7)||60 (13.8)||170 (16.1)||26 (4.0)|
|Dizziness||41 (9.6)||54 (12.4)||143 (13.6)||31 (4.8)|
|Constipation||40 (9.3)||59 (13.6)||225 (21.3)||27 (4.2)|
|Vomiting||28 (6.5)||45 (10.4)||98 (9.3)||12 (1.9)|
|Arthralgia||23 (5.4)||20 (4.6)||53 (5.0)||33 (5.1)|
|Dry Mouth||20 (4.7)||36 (8.3)||138 (13.1)||22 (3.4)|
|Sweating||18 (4.2)||23 (5.3)||71 (6.7)||4 (0.6)|
|Asthenia||15 (3.5)||26 (6.0)||91 (8.6)||17 (2.6)|
|Pruritus||13 (3.0)||25 (5.8)||77 (7.3)||12 (1.9)|
|Anorexia||9 (2.1)||23 (5.3)||60 (5.7)||1 (0.2)|
|Insomnia||9 (2.1)||9 (2.1)||53 (5.0)||11 (1.7)|
The following adverse reactions were reported from all chronic pain studies (N=1917). The lists below include adverse reactions not otherwise noted in Table 1.
Adverse reactions with incidence rates of 1.0% to < 5.0%
Cardiac disorders: hypertension
General disorders: abdominal pain, accidental injury, chills, fever, flu syndrome, neck pain, pelvic pain
Investigations: hyperglycemia, urine abnormality
Metabolism and nutrition disorders: peripheral edema, weight loss
Musculoskeletal, connective tissue and bone disorders: myalgia
Psychiatric disorders: agitation, anxiety, apathy, confusion, depersonalization, depression, euphoria, nervousness
Skin and subcutaneous tissue disorders: rash
Urogenital disorders: prostatic disorder, urinary tract infection
Vascular disorders: vasodilatation
Adverse reactions with incidence rates of 0.5% to < 1.0% at any dose and serious adverse reactions reported in at least two patients.
Gastrointestinal disorders: gastroenteritis
General disorders: neck rigidity, viral infection
Hematologic/Lymphatic disorders: anemia, ecchymoses
Respiratory disorders: pneumonia
Skin and subcutaneous tissue disorders: hair disorder, skin disorder, urticaria
Special Senses: eye disorder, lacrimation disorder
Read the entire FDA prescribing information for ConZip (Tramadol Hydrochloride Extended-release Capsules) »
Additional ConZip Information
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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.
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