Acetaminophen / caffeine / dihydrocodeine Side Effects
For the Consumer
Applies to acetaminophen / caffeine / dihydrocodeine: capsules, tablets
Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur while taking acetaminophen / caffeine / dihydrocodeine:
Constipation; dizziness; drowsiness; headache; light-headedness; mild itching; nausea; sweating; tiredness; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); change in the amount of urine produced; confusion; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes (eg, agitation, anxiety, depression); red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe or persistent constipation; severe or persistent dizziness, drowsiness, headache, or light-headedness; shortness of breath; slow, shallow, or difficult breathing; symptoms of liver problems (eg, yellowing of the eyes or skin, dark urine, pale stools, loss of appetite, unusual or severe stomach pain); trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; vision changes.
For Healthcare Professionals
Applies to acetaminophen / caffeine / dihydrocodeine: oral capsule, oral tablet
The most frequently expected adverse reactions based on the individual components may include lightheadedness, dizziness, drowsiness, sedation, nausea, vomiting, constipation, pruritus and skin reactions.[Ref]
Frequency not reported: Hepatotoxicity[Ref]
Frequency not reported: Respiratory depression, cough suppression[Ref]
Frequency not reported: Confusion, physical and psychological dependence, hallucinations vivid dreams
Frequency not reported: Anxiety, anxiety neurosis, excitement, insomnia, irritability, restlessness, tenseness[Ref]
Frequency not reported: Sweating, pruritus, skin reactions
Rare (less than 0.1%): Serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN)
Frequency not reported: Urticaria[Ref]
Frequency not reported: Anaphylactoid reactions, hypersensitivity reactions
Rare (less than 0.1%): Anaphylactoid reactions
Frequency not reported: Hypersensitivity reactions including urticarial or erythematous skin reactions, laryngeal edema, angioedema[Ref]
Postmarketing reports: Serotonin syndrome
Rare (less than 0.1%): Narcosis
Frequency not reported: Lightheadedness, dizziness, drowsiness, sedation, headache
Frequency not reported: Headaches, lightheadedness, tremor[Ref]
Rare (less than 0.1%): Acute renal failure
Frequency not reported: Granulomatous interstitial nephritis
Frequency not reported: Diuresis[Ref]
Frequency not reported: Orthostatic hypotension
Frequency not reported: Extrasystoles, palpitations, tachycardia[Ref]
Postmarketing reports: Adrenal insufficiency
Frequency not reported: Androgen deficiency[Ref]
Chronic opioid use may influence the hypothalamic-pituitary-gonadal axis and lead to androgen deficiency; however, the causal role of opioids is unknown due to the lack of studies into the many medical, physical, lifestyle, and psychological stressors that influence gonadal hormone levels.[Ref]
Frequency not reported: Nausea, vomiting, constipation, abdominal pain, diarrhea, dry mouth, indigestion, spasm of biliary tract
Frequency not reported: Diarrhea, nausea, stomach pain, vomiting[Ref]
Frequency not reported: Urinary retention[Ref]
Frequency not reported: Thrombocytopenia, leukopenia, pancytopenia, neutropenia, thrombocytopenic purpura, agranulocytosis[Ref]
Frequency not reported: Anorexia[Ref]
Frequency not reported: Miosis
Frequency not reported: Scintillating scotoma[Ref]
Frequency not reported: Fatigue
Frequency not reported: Tinnitus[Ref]
1. "Product Information. APAP/Caffeine/Dihydrocodeine Bitartrate (acetaminophen / caffeine / dihydrocodeine)." Xspire Pharma, Ridgeland, MS.
2. "Product Information. Trezix (acetaminophen / caffeine / dihydrocodeine)." WraSer Pharmaceuticals, Madison, MS.
Not all side effects for acetaminophen / caffeine / dihydrocodeine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
More about acetaminophen/caffeine/dihydrocodeine
- Acetaminophen Caffeine Dihydrocodeine (FDA)
- Acetaminophen, Caffeine, and Dihydrocodeine (Wolters Kluwer)
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