Logo

OpiCalc

FavoritesSpecialtiesDrugsGuidelinesMost Used

All Specialties

OpiCalc Logo
FavoritesSpecialtiesDrugsGuidelinesMost Used
FavesSpecsDrugsGuidesTop
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
‌
OpiCalc Logo

OpiCalc

Easy, fast, and private medical tools for clinicians. Always free.

No Login Required
Ready for the Bedside

Resources

About UsEditorial PolicyMedical DisclaimerPrivacy PolicyTerms of UseCookie Policy

Support

Contact Us

Clinical Notice:OpiCalc is not a substitute for professional clinical judgment. Always verify dosages and guidelines.

OpiCalc © 2018-2026

•

All Rights Reserved

Registry Hub
Peer-Reviewed Evidence
HomeDrug RegistryCompareALFENTA vs ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Comparative Pharmacology

ALFENTA vs ACETAMINOPHEN AND HYDROCODONE BITARTRATE Comparison

Head-to-head clinical analysis & difference comparison: details on mechanism of action, dosing, half-life, interactions, and maternal-fetal safety.

Clinical EssentialsPharmacokineticsSpecial PopulationsSafety & MonitoringPregnancy & LactationClinical Insights
Differential Analysis

ALFENTA vs ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Clinician-reviewed, head-to-head comparison of mechanism, dosing, pharmacokinetics, and safety profiles.

View ALFENTA Monograph View ACETAMINOPHEN AND HYDROCODONE BITARTRATE Monograph
ALFENTA
Opioid Analgesic
Category C
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Opioid Agonist
Category D/X
TL;DR — Key Differences
  • Drug class: ALFENTA is a Opioid Analgesic; ACETAMINOPHEN AND HYDROCODONE BITARTRATE is a Opioid Agonist.
  • Half-life: ALFENTA has a half-life of Terminal elimination half-life: 90–111 minutes (1.5–1.85 hours); prolonged in hepatic impairment.; ACETAMINOPHEN AND HYDROCODONE BITARTRATE has Acetaminophen: 2-3 hours in adults; prolonged in hepatic impairment (up to 5 hours). Hydrocodone: 3.8-4.5 hours (range 3-5 hours) in healthy adults; prolonged in elderly or hepatic/renal impairment. Clinical context: repeated dosing may require extended intervals in renal impairment..
  • Direct interaction: A moderate interaction exists when combining these agents.
  • Pregnancy: ALFENTA is rated Category C; ACETAMINOPHEN AND HYDROCODONE BITARTRATE is rated Category D/X.

Last clinically reviewed: July 2026 · OpiCalc Medical Review Team

Clinical Essentials

ALFENTA
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Mechanism of Action
ALFENTA

μ-opioid receptor agonist that activates G-protein coupled receptors to inhibit adenylate cyclase, decreasing c AMP production, leading to reduced neuronal excitability and pain transmission.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: analgesic and antipyretic effects via inhibition of cyclooxygenase (COX) and activation of descending serotonergic pathways; central action. Hydrocodone: mu-opioid receptor agonist; activates G-protein coupled receptors to modulate pain perception and emotional response.

Indications
ALFENTA

Induction and maintenance of anesthesia,Analgesic supplement during surgical procedures,Intravenous use for monitored anesthesia care (MAC)

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Moderate to moderately severe pain,Cough suppression (hydrocodone; off-label)

Standard Dosing
ALFENTA

Intravenous: Initial dose 8-20 mcg/kg (0.5-1 min) then 0.5-3 mcg/kg/min or 3-5 mcg/kg q5-20min. For short procedures: 8-20 mcg/kg. For longer procedures: 50-75 mcg/kg followed by 0.5-3 mcg/kg/min.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

1-2 tablets (containing 5-10 mg hydrocodone and 300-325 mg acetaminophen) orally every 4-6 hours as needed for pain; maximum 8 tablets per day.

Direct Interaction
ALFENTA
MODERATE Risk
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
MODERATE Risk

Pharmacokinetics

ALFENTA
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Half-Life
ALFENTA

Terminal elimination half-life: 90–111 minutes (1.5–1.85 hours); prolonged in hepatic impairment.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: 2-3 hours in adults; prolonged in hepatic impairment (up to 5 hours). Hydrocodone: 3.8-4.5 hours (range 3-5 hours) in healthy adults; prolonged in elderly or hepatic/renal impairment. Clinical context: repeated dosing may require extended intervals in renal impairment.

Metabolism
ALFENTA

Hepatic via CYP3A4 to inactive metabolites; major metabolite is desmethylalfentanil (inactive).

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: primarily via glucuronidation (UGT1A1, UGT1A6, UGT1A9) and sulfation; minor CYP2E1 oxidation to NAPQI (toxic metabolite). Hydrocodone: CYP3A4 and CYP2D6; N-demethylation to norhydrocodone; O-demethylation to hydromorphone (CYP2D6).

Excretion
ALFENTA

Primarily renal (urinary) elimination as metabolites; approximately 80% recovered in urine, 20% in feces.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: primarily renal excretion of conjugated metabolites (glucuronide and sulfate) with approximately 5% excreted unchanged. Hydrocodone: renal excretion as unchanged drug and metabolites (O-demethylated and N-demethylated); total renal excretion accounts for about 60-70% of dose (parent and metabolites). Biliary/fecal elimination is minimal.

Protein Binding
ALFENTA

Approximately 92% bound, primarily to alpha-1 acid glycoprotein and albumin.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: 10-25% bound, nonspecific binding to albumin. Hydrocodone: 25-50% bound, primarily to albumin and alpha-1-acid glycoprotein.

VD (L/kg)
ALFENTA

0.5–1.0 L/kg; reflects moderate tissue distribution; higher Vd in neonates and elderly.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: 0.8-1.0 L/kg, indicating distribution into total body water; clinically relevant for loading dose calculations. Hydrocodone: 3.0-4.0 L/kg, suggesting extensive tissue distribution; higher Vd may require higher loading doses but has no clinical target.

Bioavailability
ALFENTA

Intravenous: 100%; intramuscular: approximately 90%; intrathecal: approximately 10% (due to systemic absorption following spinal administration).

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen: oral bioavailability 85-95% (first-pass metabolism minimal). Hydrocodone: oral bioavailability about 25-45% due to first-pass hepatic metabolism; significant interindividual variability.

Special Populations

ALFENTA
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Renal Adjustments
ALFENTA

No specific dose adjustment is recommended for renal impairment; however, alfentanil is primarily metabolized in the liver and its pharmacokinetics are not significantly altered in renal failure.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

GFR 10-50 m L/min: administer every 6 hours; GFR <10 m L/min: administer every 8 hours; avoid in severe impairment due to acetaminophen metabolite accumulation.

Hepatic Adjustments
ALFENTA

In hepatic impairment (Child-Pugh class A, B, C): Reduce dose by 50% and titrate carefully due to prolonged elimination half-life. Consider lower initial doses and extended dosing intervals.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Child-Pugh A: no adjustment; Child-Pugh B: reduce dose by 50% or extend interval; Child-Pugh C: use with caution, avoid if possible, consider alternative therapy.

Pediatric Dosing
ALFENTA

Children (1-12 years): Induction of anesthesia: 10-20 mcg/kg IV; maintenance: 5-10 mcg/kg IV or infusion 0.5-1 mcg/kg/min. For neonates and infants: Dose individualization required; titrate to effect.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Dosing based on hydrocodone component: 0.1-0.2 mg/kg/dose every 4-6 hours; maximum daily acetaminophen limit: 75 mg/kg/day; not recommended for children <2 years.

Geriatric Dosing
ALFENTA

Elderly patients (>65 years): Reduce initial dose by 30-50% and administer slowly. Due to decreased clearance and increased sensitivity, lower infusion rates (e.g., 0.3-0.5 mcg/kg/min) may be needed.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Initiate at lowest effective dose, typically 1 tablet (2.5-5 mg hydrocodone) every 6 hours; monitor for respiratory depression and acetaminophen toxicity; avoid in frail elderly with hepatic impairment.

Safety & Monitoring

ALFENTA
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Black Box Warnings
ALFENTA
FDA Black Box Warning

Risk of respiratory depression, particularly in elderly or debilitated patients. Concomitant use with benzodiazepines or other CNS depressants may cause profound sedation, respiratory depression, coma, and death.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE
FDA Black Box Warning

Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion of acetaminophen; neonatal opioid withdrawal syndrome; interaction with alcohol; risk of medication errors.

Warnings/Precautions
ALFENTA

Respiratory depression; abuse potential; hypotension; bradycardia; muscle rigidity; serotonin syndrome with concurrent serotonergic drugs; adrenal insufficiency; risk of withdrawal with prolonged use.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Hepatotoxicity from acetaminophen overdose; respiratory depression; increased intracranial pressure; CNS depression; elderly/debilitated patients; renal impairment; opioid-induced hyperalgesia; serotonin syndrome; interaction with CNS depressants; risk of adrenal insufficiency; severe hypotension; use in patients with gastrointestinal obstruction; convulsion risk; severe hepatic impairment; urinary retention; acute abdominal conditions; hypothyroidism; prostatic hypertrophy; adrenocortical insufficiency; pregnancy/lactation; pediatric use; geriatric use; renal impairment; hepatic impairment.

Contraindications
ALFENTA

Hypersensitivity to alfentanil or any component; significant respiratory insufficiency; severe asthma; paralytic ileus; concurrent use of MAOIs (or within 14 days); acute or postoperative pain management in children (except for procedural sedation).

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Hypersensitivity to acetaminophen or hydrocodone; significant respiratory depression; acute or severe bronchial asthma; upper airway obstruction; known or suspected gastrointestinal obstruction; paralytic ileus; concomitant use of monoamine oxidase inhibitors (MAOIs) or within 14 days; severe hepatic impairment (acetaminophen toxicity risk); acute alcoholism.

Adverse Reactions
ALFENTA
Data Pending
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Data Pending
Food Interactions
ALFENTA

No known interactions with food. However, grapefruit juice may increase alfentanil serum concentrations due to CYP3A4 inhibition; avoid concurrent consumption.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Avoid alcohol consumption during therapy; ethanol increases acetaminophen hepatotoxicity risk and enhances CNS depression. Grapefruit juice may inhibit CYP2D6 (minor effect) but no significant clinical interaction. No other specific food restrictions.

Pregnancy & Lactation

ALFENTA
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Teratogenic Risk
ALFENTA

Alfentanil, a short-acting opioid analgesic, is classified as FDA Pregnancy Category C. No well-controlled studies in pregnant women exist. In animal studies, no teratogenic effects were observed at clinically relevant doses; however, high doses caused embryotoxicity and increased fetal mortality. Trimester-specific risks: First trimester - potential for minor malformations based on limited human data; second trimester - possible risk if used chronically; third trimester - prolonged use may lead to neonatal respiratory depression, withdrawal syndrome, or opioid dependence. Use only if benefits outweigh risks.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

First trimester: Acetaminophen considered low risk; hydrocodone is a pregnancy category C drug. Data from retrospective studies suggest a small increased risk of certain congenital malformations (e.g., neural tube defects, cleft palate) with first trimester opioid use, but absolute risk is low. Second trimester: Low risk as above. Third trimester: Prolonged use of hydrocodone can cause neonatal opioid withdrawal syndrome (NOWS); acetaminophen is safe. Use only if benefit outweighs risk.

Lactation Summary
ALFENTA

Alfentanil is excreted into human breast milk in low concentrations. The milk-to-plasma (M/P) ratio is approximately 0.3. Estimated infant dose is <1% of maternal weight-adjusted dose, which is considered clinically insignificant. However, due to potential for neonatal opioid effects, caution is advised; monitor infant for drowsiness, respiratory depression, and feeding difficulties. Consider alternative analgesics with established safety profiles, such as acetaminophen or ibuprofen, for lactation.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen excretion in breast milk is low (M/P ratio ~0.9). Hydrocodone is excreted in small amounts (M/P ratio ~2.1). The relative infant dose is estimated to be 2.5-3.5% of maternal weight-adjusted dose for hydrocodone. Monitor infant for sedation and respiratory depression. Consider benefit to mother and potential neonatal opioid withdrawal if used chronically.

Pregnancy Dosing
ALFENTA

Pregnancy can alter pharmacokinetics of alfentanil. Increased plasma volume and distribution may require higher doses to achieve same effect, while decreased plasma protein binding may increase free fraction, potentiating effects. Alpha-1-acid glycoprotein levels change in pregnancy, affecting binding. In third trimester, clearance may be increased by up to 50% due to enhanced hepatic metabolism. Therefore, dose adjustments may be needed: consider starting at low dose and titrating to effect, with close monitoring. For intravenous administration, typical adult doses (5-20 μg/kg) may need adjustments; no standard pregnancy-specific dosing exists. Use the lowest effective dose for the shortest duration. In labor, avoid high doses prior to delivery due to risk of neonatal respiratory depression.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

During pregnancy, increased plasma volume and enhanced hepatic clearance may reduce serum concentrations of both drugs. However, dosing adjustments are not routinely recommended due to risk of undertreatment. Use the lowest effective dose of hydrocodone for the shortest duration. For acetaminophen, maximum daily dose should not exceed 3000 mg to avoid hepatotoxicity.

Maternal Safety Status
ALFENTA
Category C
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Category D/X

Clinical Insights

ALFENTA
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
Clinical Pearls
ALFENTA

Alfentanil is a potent, rapid-onset, short-acting opioid analgesic used primarily for induction and maintenance of anesthesia. Due to its high protein binding (90%) and rapid redistribution, it has a shorter duration of action than fentanyl, making it suitable for brief, painful procedures. It undergoes hepatic metabolism via CYP3A4, so concomitant use with CYP3A4 inhibitors like ketoconazole or erythromycin can prolong its effects. Use caution in elderly or hypovolemic patients due to increased risk of hypotension. Naloxone reverses respiratory depression. Alfentanil is 5-10 times less potent than fentanyl.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Acetaminophen-hydrocodone is contraindicated in severe respiratory depression, acute or severe bronchial asthma, and known hypersensitivity. Monitor for respiratory depression, especially in elderly or debilitated patients. Avoid use with other acetaminophen-containing products to prevent hepatotoxicity. Hydrocodone is a prodrug metabolized by CYP2D6 to hydromorphone; CYP2D6 ultrarapid metabolizers may experience toxicity. Use with caution in patients with head injury, increased intracranial pressure, or severe hepatic impairment. Naloxone is the reversal agent for opioid effects; acetylcysteine for acetaminophen overdose.

Patient Counseling
ALFENTA

This medication is given only by a healthcare professional in a hospital or surgical setting.,You may feel drowsy, dizzy, or nauseated after receiving this drug.,Report any difficulty breathing or slow heart rate to your healthcare provider immediately.,Avoid alcohol and sedatives for 24 hours after administration, as they can increase side effects.,Do not drive or operate machinery until the effects have fully worn off.

ACETAMINOPHEN AND HYDROCODONE BITARTRATE

Take exactly as prescribed; do not increase dose or frequency without consulting your doctor.,Avoid alcohol and other CNS depressants (e.g., benzodiazepines, sedatives) as they increase risk of severe drowsiness and respiratory depression.,Do not exceed 4000 mg of acetaminophen per day from all sources; check labels of other medications.,This medication may cause dizziness or drowsiness; avoid driving or operating heavy machinery until you know how it affects you.,Store securely out of reach of others, especially children, as misuse can cause overdose and death.,Do not stop abruptly; withdrawal may occur. Taper under medical supervision.,Contact emergency if you experience trouble breathing, extreme drowsiness, or signs of allergic reaction.,Report any history of substance abuse, as this medication has abuse potential.

Safety Verification

Known Interactions

ALFENTA Risks3
Propantheline + Alfentanil
moderate

"Propantheline, an anticholinergic agent, can competitively antagonize muscarinic acetylcholine receptors, potentially reducing gastrointestinal motility and secretion. Alfentanil, a mu-opioid receptor agonist, also decreases gastrointestinal motility through central and peripheral opioid receptors. Concomitant use may synergistically inhibit peristalsis, leading to severe constipation, paralytic ileus, or delayed gastric emptying, which can increase the risk of aspiration and complicate anesthesia recovery."

Alfentanil + Furosemide
moderate

"Alfentanil, a potent opioid analgesic, can cause significant hypotension and respiratory depression. When combined with furosemide, a loop diuretic that reduces blood volume and vascular resistance, there is a synergistic decrease in blood pressure, which may precipitate cardiovascular collapse, especially in patients with compromised circulatory reserves. Additionally, furosemide may enhance the sedative and respiratory depressant effects of alfentanil, leading to increased risk of respiratory acidosis and altered mental status."

Alfentanil + Nebivolol
moderate

"Alfentanil, a potent mu-opioid receptor agonist, can enhance the bradycardic effects of nebivolol, a beta-1 selective blocker with additional nitric oxide-mediated vasodilation. The combination may lead to excessive slowing of heart rate, reduced cardiac output, and potential hemodynamic instability, particularly in patients with underlying cardiac conduction abnormalities or hypovolemia."

ACETAMINOPHEN AND HYDROCODONE BITARTRATE Risks3
Hydrocodone + Scopolamine
moderate

"Hydrocodone, an opioid agonist, and scopolamine, an anticholinergic agent, both exhibit central nervous system (CNS) depressant effects. When co-administered, their combined activity can lead to additive CNS depression, resulting in enhanced sedation, respiratory depression, and cognitive impairment. This interaction may also increase the risk of constipation and urinary retention due to additive anticholinergic effects from both drugs."

Pargyline + Hydrocodone
moderate

"Pargyline, a monoamine oxidase inhibitor (MAOI), irreversibly inhibits the metabolism of amines, leading to increased intraneuronal stores of norepinephrine. Hydrocodone, a semisynthetic opioid, can release these stored catecholamines, potentially causing a hypertensive crisis, serotonin syndrome, or CNS excitation. Coadministration may also result in excessive sedation and respiratory depression due to additive CNS depressant effects, requiring immediate clinical attention."

Hydrocodone + Oxprenolol
moderate

"Hydrocodone, an opioid agonist, and oxprenolol, a non-selective beta-adrenoceptor antagonist, are both central nervous system (CNS) depressants. Their combined use can lead to additive CNS depression, resulting in excessive sedation, respiratory depression, hypotension, and bradycardia. This interaction is particularly dangerous in patients with compromised cardiac or respiratory function, potentially leading to coma or death."

Compare Alternatives

Related Drug Comparisons

Explore head-to-head clinical comparisons of other medications in the same therapeutic classes.

ALFENTA vs ABSTRALOpioid Analgesic
ACETAMINOPHEN AND HYDROCODONE BITARTRATE vs ABSTRALOpioid Analgesic
ALFENTA vs ACEPHENNon-Opioid Analgesic
ACETAMINOPHEN AND HYDROCODONE BITARTRATE vs ACEPHENNon-Opioid Analgesic
ALFENTA vs ACTIQOpioid Analgesic
ACETAMINOPHEN AND HYDROCODONE BITARTRATE vs ACTIQOpioid Analgesic
ALFENTA vs ALFENTANILOpioid Analgesic
ACETAMINOPHEN AND HYDROCODONE BITARTRATE vs ALFENTANILOpioid Analgesic
ALFENTA vs ANEXSIAOpioid Analgesic Combination
Clinical Q&A

Frequently Asked Questions

Common clinical questions about ALFENTA vs ACETAMINOPHEN AND HYDROCODONE BITARTRATE, answered by our medical review team.

1. What is the main difference between ALFENTA and ACETAMINOPHEN AND HYDROCODONE BITARTRATE?

ALFENTA is a Opioid Analgesic that works by μ-opioid receptor agonist that activates G-protein coupled receptors to inhibit adenylate cyclase, decreasing c AMP production, leading to reduced neuronal excitability and pain transmission.. ACETAMINOPHEN AND HYDROCODONE BITARTRATE is a Opioid Agonist that works by Acetaminophen: analgesic and antipyretic effects via inhibition of cyclooxygenase (COX) and activation of descending serotonergic pathways; central action. Hydrocodone: mu-opioid receptor agonist; activates G-protein coupled receptors to modulate pain perception and emotional response.. They differ in pharmacokinetic profiles, FDA-approved indications, and side effect profiles.

2. Which is stronger: ALFENTA or ACETAMINOPHEN AND HYDROCODONE BITARTRATE?

Potency comparisons between ALFENTA and ACETAMINOPHEN AND HYDROCODONE BITARTRATE depend on the specific clinical indication. These are agents from distinct pharmacological classes and are not directly interchangeable by dose. A physician or clinical pharmacist should guide any therapeutic switching decisions.

3. What is the standard dosing for ALFENTA vs ACETAMINOPHEN AND HYDROCODONE BITARTRATE?

The standard adult dose of ALFENTA is: Intravenous: Initial dose 8-20 mcg/kg (0.5-1 min) then 0.5-3 mcg/kg/min or 3-5 mcg/kg q5-20min. For short procedures: 8-20 mcg/kg. For longer procedures: 50-75 mcg/kg followed by 0.5-3 mcg/kg/min.. The standard adult dose of ACETAMINOPHEN AND HYDROCODONE BITARTRATE is: 1-2 tablets (containing 5-10 mg hydrocodone and 300-325 mg acetaminophen) orally every 4-6 hours as needed for pain; maximum 8 tablets per day.. Dosing should always be individualized based on indication, renal and hepatic function, age, and other patient factors.

4. Can you take ALFENTA and ACETAMINOPHEN AND HYDROCODONE BITARTRATE together?

A moderate-severity drug interaction has been identified when combining ALFENTA and ACETAMINOPHEN AND HYDROCODONE BITARTRATE. Hydrocodone may increase the central nervous system depressant (CNS depressant) activities of Alfentanil. Consult your prescriber before combining these medications.

5. Are ALFENTA and ACETAMINOPHEN AND HYDROCODONE BITARTRATE safe during pregnancy?

The maternal-fetal safety profiles differ. ALFENTA is classified as Category C. Alfentanil, a short-acting opioid analgesic, is classified as FDA Pregnancy Category C. No well-controlled studies in pregnant women exist. In animal studies, no teratogenic effect. ACETAMINOPHEN AND HYDROCODONE BITARTRATE is classified as Category D/X. First trimester: Acetaminophen considered low risk; hydrocodone is a pregnancy category C drug. Data from retrospective studies suggest a small increased risk of certain congenital. Always consult a maternal-fetal medicine specialist before taking either drug during pregnancy or lactation.