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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).

Preferred Term CONZIP™ PLACEBO
(N=646)
n (%)
100 mg
(N=429)
n (%)
200 mg
(N=434)
n (%)
300 mg
(N=1054)
n (%)
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

Gastrointestinal disorders: dyspepsia, flatulence

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

Nervous system disorders: paresthesia, tremor, withdrawal syndrome

Psychiatric disorders: agitation, anxiety, apathy, confusion, depersonalization, depression, euphoria, nervousness

Respiratory, thoracic and mediastinal disorders: bronchitis, pharyngitis, rhinitis, sinusitis

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.

Cardiac disorders: EKG abnormal, hypotension, tachycardia

Gastrointestinal disorders: gastroenteritis

General disorders: neck rigidity, viral infection

Hematologic/Lymphatic disorders: anemia, ecchymoses

Metabolism and nutrition disorders: blood urea nitrogen increased, GGT increased, gout, SGPT increased

Musculoskeletal disorders: arthritis, arthrosis, joint disorder, leg cramps

Nervous system disorders: emotional lability, hyperkinesia, hypertonia, thinking abnormal, twitching, vertigo

Respiratory disorders: pneumonia

Skin and subcutaneous tissue disorders: hair disorder, skin disorder, urticaria

Special Senses: eye disorder, lacrimation disorder

Urogenital disorders: cystitis, dysuria, sexual function abnormality, urinary retention