Codeine 30 mg is a mid-strength immediate-release tablet of codeine sulfate, an opioid analgesic used to treat mild to moderately severe pain. It is a Schedule II controlled substance in the United States, the most restrictive category, because it can be abused or lead to dependence.

The 30 mg strength sits between the 15 mg starting dose and the 60 mg maximum tablet strength. It is commonly used when 15 mg does not provide adequate analgesia but higher doses are not yet necessary.

What Codeine 30 mg Is Prescribed For

Codeine sulfate tablets are FDA-approved for one indication:

• Relief of mild to moderately severe pain where the use of an opioid analgesic is appropriate.

Important limitation: Codeine is not a first-line treatment. It should be used only when non-opioid options have been inadequate, and at the lowest effective dose for the shortest duration necessary.

Active Ingredients

The active ingredient is codeine sulfate, an opioid agonist that binds to mu-opioid receptors in the central nervous system.

The 30 mg tablet is described as a white to off-white, biconvex tablet, scored on one side with “30” debossed on the scored side and “54 783” debossed on the other side.

Available Strengths

Codeine sulfate tablets are available in three strengths:

15 mg Starting dose; mild pain 30 mg Moderate pain; titration step 60 mg Maximum single doseKey principle: Adult doses of codeine higher than 60 mg fail to give commensurate relief of pain and are associated with an appreciably increased incidence of undesirable side effects.

Dosage Guidelines

Usual Adult Dosage: 15 mg to 60 mg repeated up to every 4 hours as needed for pain. The maximum 24-hour dose is 360 mg.

Individualization: The initial dose should be titrated based on the individual patient’s response. Tolerance to codeine can develop with continued use, and the incidence of untoward effects is dose-related.

Cessation: When therapy is no longer required, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

Key principle: It is safer to underestimate a patient’s 24-hour dose than to overestimate it, because overestimation can result in fatal overdose with the first dose.

Important Safety Information (Boxed Warning)

Death Related to Ultra-Rapid Metabolism of Codeine to Morphine: Respiratory depression and death have occurred in children who received codeine following tonsillectomy and/or adenoidectomy and had evidence of being ultra-rapid metabolizers of codeine due to a CYP2D6 polymorphism. Deaths have also occurred in nursing infants exposed to high levels of morphine in breast milk because their mothers were ultra-rapid metabolizers.

Prevalence of Ultra-Rapid Metabolism: This phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1 to 10% in Caucasians, 3% in African Americans, and 16 to 28% in North Africans, Ethiopians, and Arabs.

Addiction, Abuse, and Misuse: Codeine exposes patients to risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing and monitor regularly.

Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dose increase. Monitor closely, particularly within the first 24 to 72 hours of starting therapy.

Accidental Ingestion: Accidental ingestion of even one dose, especially by children, can result in a fatal overdose of codeine.

Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can result in withdrawal in the neonate, which may be life-threatening if not recognized and treated.

Common Side Effects

The most common adverse reactions include:

• Drowsiness
• Lightheadedness
• Dizziness
• Sedation
• Shortness of breath
• Nausea
• Vomiting
• Sweating

Important Warnings

Respiratory Depression: Codeine produces dose-related respiratory depression by direct action on brain stem respiratory centers. At higher doses, codeine has most of the disadvantages of morphine including respiratory depression.

Interactions with CNS Depressants: Concomitant use of opioids with benzodiazepines, alcohol, or other CNS depressants may result in profound sedation, respiratory depression, coma, and death.

Adrenal Insufficiency: Cases have been reported with opioid use, more often following greater than one month of use. Presentation may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.

Severe Hypotension: Codeine may cause severe hypotension. Avoid use in patients with circulatory shock.

Seizures: Codeine may increase seizure frequency in patients with seizure disorders.

Serotonin Syndrome: A potentially life-threatening condition that may occur when codeine is taken with serotonergic drugs. Symptoms include fever, sweating, muscle stiffness, confusion, and fast heartbeat.

Sexual Function: Long-term use of opioids may lead to decreased sex hormone levels, low libido, erectile dysfunction, or infertility.

Drug Interactions

MAOIs (Monoamine Oxidase Inhibitors): Concurrent use or use within 14 days of stopping an MAOI is contraindicated. Risk of hypotension, hyperpyrexia, somnolence, or death.

CNS Depressants (benzodiazepines, alcohol, sedatives): Additive CNS depression. Reserve concomitant prescribing for patients with no alternative options. Limit dosages and durations to the minimum required.

Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue codeine if suspected.

Mixed Agonist/Antagonist Opioids (buprenorphine, nalbuphine, pentazocine): May reduce analgesic effect or precipitate withdrawal symptoms.

CYP2D6 Inhibitors (fluoxetine, paroxetine, quinidine): May decrease conversion of codeine to morphine, reducing efficacy. After stopping a CYP2D6 inhibitor, morphine levels may increase, potentially causing fatal respiratory depression.

CYP3A4 Inhibitors (erythromycin, ketoconazole, ritonavir): May increase codeine exposure and risk of respiratory depression.

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Who Should Not Take Codeine 30 mg

Codeine is contraindicated in:

• All children younger than 12 years of age
• Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy
• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment
• Concurrent use of MAOIs or use within the last 14 days
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Hypersensitivity to codeine

How Prescriptions Work

As a Schedule II controlled substance, codeine 30 mg prescriptions are subject to strict federal and state regulations:

• No refills: Federal law prohibits refills on Schedule II prescriptions. A new prescription is required each time.
• Tapering required: Discontinuation should be gradual in physically-dependent patients. Abrupt discontinuation can cause withdrawal symptoms.
• Safe storage: Store codeine securely, out of sight and reach of children, and in a location not accessible by others.
• Disposal: Dispose of unused tablets by taking them to a DEA-registered collector or drug take-back program. If unavailable, mix with dirt, cat litter, or coffee grounds, place in a sealed bag, and throw in the trash.
• Never share: Never give anyone else your codeine. Selling or giving away codeine is against the law.

Frequently Asked Questions

Is codeine 30 mg safe for long-term use?
Codeine should be used at the lowest effective dose for the shortest duration necessary. Long-term use increases the risk of dependence, tolerance, and opioid-induced hyperalgesia.

Can I stop taking codeine 30 mg suddenly?
No. Abrupt discontinuation in a physically-dependent patient can cause serious withdrawal symptoms. A gradual taper under medical supervision is required.

Can I drink alcohol while taking codeine 30 mg?
No. Alcohol increases the risk of severe side effects from codeine, including decreased blood pressure, seizures, breathing problems, and severe drowsiness. The combination can be fatal.

What happens if I take too much codeine?
Seek emergency help immediately. Signs of overdose include extreme sleepiness, confusion, shallow breathing, pinpoint pupils, and clammy skin. Naloxone (Narcan) should be administered if available.

What is an ultra-rapid metabolizer?
Some individuals have a genetic variation (CYP2D6 polymorphism) that causes them to convert codeine to morphine more rapidly and completely. This can result in life-threatening or fatal respiratory depression even at labeled doses. The prevalence ranges from 0.5% in Chinese and Japanese populations to 16–28% in North Africans, Ethiopians, and Arabs.

Is codeine safe during pregnancy?
Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. Use only if clearly needed and discuss risks with your healthcare provider.

How does codeine 30 mg compare to codeine 15 mg?
Codeine 30 mg is one titration step higher than 15 mg. The 15 mg strength is typically used as a starting dose or for mild pain, while 30 mg is used for moderate pain or when 15 mg provides inadequate relief.

Is codeine 30 mg available without a prescription?
No. Codeine is a Schedule II controlled substance in the United States, and no legal source dispenses it without a valid prescription from a DEA-registered provider.

Conclusion

Codeine 30 mg is a mid-strength immediate-release opioid analgesic approved for mild to moderately severe pain. As a Schedule II controlled substance, it carries a boxed warning for death related to ultra-rapid metabolism of codeine to morphine, addiction, abuse, misuse, life-threatening respiratory depression, accidental ingestion, and neonatal opioid withdrawal syndrome. The most serious risk is the genetic variability in CYP2D6 metabolism—ultra-rapid metabolizers can experience fatal respiratory depression even at labeled doses, with prevalence ranging from 0.5% to 28% depending on ethnicity. Common side effects include drowsiness, dizziness, nausea, and sweating. Serious risks include respiratory depression when combined with CNS depressants, adrenal insufficiency, severe hypotension, seizures, and serotonin syndrome. The usual adult dose is 15 mg to 60 mg every 4 hours as needed, with a maximum of 360 mg per 24 hours. Codeine should be used at the lowest effective dose for the shortest duration necessary, never combined with alcohol or other CNS depressants, and never stopped abruptly in physically-dependent patients. Due to its controlled status, codeine requires a valid prescription and is subject to strict federal and state regulations.