Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, abuse, and misuse [ see Warnings and Precautions (5.1), Drug Abuse and Dependence (9.3) ] Life-threatening respiratory depression [ see Warnings and Precautions (5.2, 5.3 , 5.4 , 5.5 , 5.6 ), Overdosage (10) ] Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children [ see Warnings and Precautions (5.3) ] Accidental overdose and death due to medication errors [ see Warnings and Precautions (5.7) ] Decreased mental alertness with impaired mental and/or physical abilities [ see Warnings and Precautions (5.8) ] Interactions with benzodiazepines and other CNS depressants [ see Warnings and Precautions (5.10) ] Paralytic ileus, gastrointestinal adverse reactions [ see Warnings and Precautions (5.11) ] Increased intracranial pressure [ see Warnings and Precautions (5.12) ] Obscured clinical course in patients with head injuries [ see Warnings and Precautions (5.12) ] Neuroleptic Malignant Syndrome [ see Warnings and Precautions (5.13) ] Paradoxical reactions, including dystonias [ see Warnings and Precautions (5.14) ] Seizures [ see Warnings and Precautions (5.15) ] Interactions with MAOI [ see Warnings and Precautions (5.16) ] Bone marrow suppression [ see Warnings and Precautions (5.17) ] Severe hypotension [ see Warnings and Precautions (5.18) ] Neonatal Opioid Withdrawal Syndrome [ see Warnings and Precautions (5.19) ] Adrenal insufficiency [ see Warnings and Precautions (5.20) ] The following adverse reactions have been identified during clinical studies, in the literature, or during postapproval use of codeine and/or promethazine.
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 Promethazine HCl and Codeine Phosphate Oral Solution include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, shortness of breath, sweating.
Other reactions include: Anaphylaxis : Anaphylaxis has been reported with codeine, one of the ingredients in Promethazine HCl and Codeine Phosphate Oral Solution.
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, diplopia, facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tinnitus, tremor, vertigo.
Dermatologic : Flushing, hyperhidrosis, photosensitivity, pruritus, rash, urticaria.
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.
5 WARNINGS AND PRECAUTIONS See Boxed WARNINGS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients : Monitor closely, particularly during initiation of therapy.
( 5.6 ) Activities requiring mental alertness : Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery.
( 5.8 ) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors : Avoid use.
May increase intracranial pressure and obscure the clinical course of head injuries.
( 5.12 ) Neuroleptic Malignant Syndrome : Monitor during therapy.
Like all medications, Promethazine Hydrochloride And Codeine Phosphate can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: