TUZISTRA XR SIDE EFFECTS

SIDE EFFECTS

The following serious adverse reactions are described, or described in greater detail, in other sections:

• Addiction, abuse, and misuse
• Life-threatening respiratory depression
• Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children
• Accidental overdose and death due to medication errors
• Decreased mental alertness with impaired mental and/or physical abilities
• Interactions with benzodiazepines and other CNS depressants
• Paralytic ileus, gastrointestinal adverse reactions
• Increased intracranial pressure
• Obscured clinical course in patients with head injuries
• Seizures
• Interactions with MAOI
• Severe hypotension
• Neonatal Opioid Withdrawal Syndrome
• Adrenal insufficiency

The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of codeine and/or chlorpheniramine. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most common adverse reactions to TUZISTRA XR include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, shortness of breath, and sweating.

Other reactions include:

Anaphylaxis: Anaphylaxis has been reported with codeine, one of the ingredients in TUZISTRA XR.

Body as a whole: Coma, death, fatigue, falling injuries, lethargy.

Cardiovascular: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush.

Central Nervous System: Ataxia, facial dyskinesia, insomnia, increased intracranial pressure, migraine, seizure, tremor, tinnitus, vertigo.

Dermatologic: Flushing, hyperhidrosis, pruritus, rash.

Endocrine/Metabolic: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Cases of androgen deficiency have occurred with chronic use of opioids.

Gastrointestinal: Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi).

Genitourinary: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention.

Hematologic: Agranulocytosis, aplastic anemia, and thrombocytopenia have been reported.

Laboratory: Increases in serum amylase.

Musculoskeletal: Arthralgia, backache, muscle spasm.

Ophthalmic: Blurred vision, diplopia, miosis (constricted pupils), visual disturbances.

Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression, hallucinations.

Reproductive: Hypogonadism, infertility.

Respiratory: Bronchitis, cough, dry nose, dry throat, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, thickening of bronchial secretions, tightness of chest and wheezing, upper respiratory tract infection.

Other: Drug abuse, drug dependence, opioid withdrawal syndrome.

SRC: NLM .