Prescription medication · Opioid Analgesic
codeine
Also sold as Codeine Sulfate. This medicine is used to manage mild to moderate pain.
Data updated 2026-05-15
- 3,245
- FDA reportsLightly reported
- 27
- InteractionsSeveral interactions
- 1
- Recall record
What the data shows
codeine (Codeine Sulfate) is a prescription Opioid Analgesic, among the least-reported drugs the FDA tracks (3,245 FDA reports), with 27 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
codeine (Codeine Sulfate) is a prescription Opioid Analgesic. This medicine is used to manage mild to moderate pain.
This medicine contains acetaminophen and codeine. It is used to treat mild to moderate pain when other pain medicines are not strong enough.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.67/unit
Generic Available
Yes (1 manufacturer)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine is used to manage mild to moderate pain.
Common side effects
Feeling drowsy, Lightheadedness, Dizziness
Key warnings
This medicine can be habit-forming, leading to addiction, abuse, and misuse, which can result in overdose and death.
The sections below are summarized in plain English from codeine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Codeine works in the brain to change how your body feels and responds to pain. Acetaminophen also helps to relieve pain. Together, they provide pain relief.
How to Take It
Take this medicine exactly as your doctor tells you. Use the lowest dose that works for the shortest time needed. Adults usually take 1 to 2 tablets every 4 hours as needed for pain. You can take it with or without food.
This is a plain-language summary of codeine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
This medicine can cause withdrawal symptoms in newborns if taken during pregnancy. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine passes into breast milk.
This is a plain-language summary of codeine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of codeine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store this medicine at room temperature, away from light and moisture.
Side Effects (from patient reports)
Based on 3,245 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for codeine, by number of reports
- Allergic reaction to the medicine
Allergic reaction to the medicine
806 reports
- Feeling sick to your stomach
Feeling sick to your stomach
487 reports
- Feeling unwell
Feeling unwell
374 reports
- Throwing up
Throwing up
364 reports
- Head pain
Head pain
356 reports
- Joint pain
Joint pain
354 reports
- Loose stools
Loose stools
343 reports
- Difficulty breathing
Difficulty breathing
327 reports
- Coughing 300
Coughing
300 reports
- Tiredness 300
Tiredness
300 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for codeine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where codeine sits
codeine has more FDA adverse-event reports than 19% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is codeine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 3,245 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
3,245
Reports Mentioning Death
798
24.6% of reports — not proof of cause
Hospitalization Reports
643
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG HYPERSENSITIVITY | 807 |
| 2 | NAUSEA | 488 |
| 3 | MALAISE | 374 |
| 5 | VOMITING | 365 |
| 6 | HEADACHE | 356 |
| 7 | ARTHRALGIA | 354 |
| 8 | DIARRHOEA | 343 |
| 9 | DYSPNOEA | 327 |
| 10 | FATIGUE | 301 |
| 11 | COUGH | 300 |
| 12 | PAIN | 279 |
| 13 | PRURITUS | 268 |
| 14 | ABDOMINAL PAIN UPPER | 261 |
| 15 | ASTHENIA | 258 |
| 16 | RASH | 252 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
This medicine can be habit-forming, leading to addiction, abuse, and misuse, which can result in overdose and death. Serious, life-threatening breathing problems can occur, especially when starting the medicine or after a dose increase. Accidental ingestion, especially by children, can cause a fatal overdose. Do not give this medicine to children under 12 years old, or to children under 18 after tonsil or adenoid removal, due to the risk of life-threatening breathing problems. This medicine can also harm your liver. Taking this medicine with certain other medicines like benzodiazepines or other CNS depressants can cause serious side effects, including death.
Known Drug Interactions
The concomitant use of acetaminophen and codeine phosphate tablets and CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion, quinidine) can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced analgesic efficacy or symptoms of opioid withdrawal, particularly when an inhibitor is added after a stable dose of acetaminophen and codeine phosphate tablets is achieved (see CLINICAL PHARMACOLOGY ).
Mechanism: Bupropion blocks the body from changing codeine into morphine, which is the active part that relieves pain. This can make the medicine less effective or cause withdrawal symptoms.
What to do: Your doctor may need to adjust your dose or monitor you closely to ensure your pain is still being managed.
The concomitant use of acetaminophen and codeine phosphate tablets and CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, bupropion, quinidine) can increase the plasma concentration of codeine, but can decrease the plasma concentration of active metabolite morphine, which could result in reduced analgesic efficacy or symptoms of opioid withdrawal, particularly when an inhibitor is added after a stable dose of acetaminophen and codeine phosphate tablets is achieved (see CLINICAL PHARMACOLOGY ).
Mechanism: Fluoxetine prevents codeine from being converted into its active form, morphine. This can lead to poor pain control or cause you to feel symptoms of opioid withdrawal.
What to do: Tell your doctor if your pain is not well-controlled, as they may need to change your medication or dosage.
Examples of these drugs include, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (used to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) (see PRECAUTIONS; Information for Patients/Caregivers ).
Mechanism: Both of these drugs affect a chemical in the brain called serotonin. Taking them together can cause serotonin levels to become too high, which can be dangerous.
What to do: Watch for signs of serotonin syndrome, such as a fast heartbeat or confusion, and talk to your doctor about using these together safely.
Examples of these drugs include, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (used to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) (see PRECAUTIONS; Information for Patients/Caregivers ).
Mechanism: These medications both increase the amount of serotonin in your body. Having too much serotonin can lead to a serious condition called serotonin syndrome.
What to do: Use caution when taking these together and report any symptoms like sweating, muscle stiffness, or agitation to your healthcare provider.
Examples of these drugs include, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), and monoamine oxidase (MAO) inhibitors (used to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) (see PRECAUTIONS; Information for Patients/Caregivers ).
Mechanism: Taking these two drugs together can raise serotonin levels in your brain to an unsafe level. This increases the risk of a serious reaction called serotonin syndrome.
What to do: Your healthcare provider should monitor you closely for any signs of a serotonin reaction while you are taking both medications.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I drive while taking this medicine?
Can I drink alcohol while taking this medicine?
What should I do if I overdose?
Can I take this medicine with other pain relievers?
How long does it take for this medicine to work?
Can I become addicted to this medicine?
What are the signs of an allergic reaction?
Can I stop taking this medicine suddenly?
What should I tell my doctor before taking this medicine?
How should I dispose of unused medicine?
What are the common side effects of codeine?
Does codeine interact with other medications?
What drug class is codeine?
Is codeine safe during pregnancy?
Has codeine been recalled?
Active Recalls
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Akorn, Inc.
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for codeine
The FDA label for codeine (sold under brand names such as Codeine Sulfate) classifies it as a prescription-only medication in the Opioid Analgesic class. This medicine is used to manage mild to moderate pain. Official labeling lists 9 commonly reported side effects, including Feeling drowsy, Lightheadedness, Dizziness.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 3,245 voluntary reports. The database also lists 27 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $0.67.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: December 26, 2024
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages