Generic name
Promethazine hydrochloride and codeine phosphate: adverse event reports filed with FDA
3,549 reports list it as a suspect or interacting product, 2021–2026. Class: Opioid agonist. Also reported as Promethazine Hydrochloride And Codeine Phosphate Oral Solution.
- 3,549
- reports as suspect product
- 0% of all reports · about 687 a year
- 6
- reports, 12 months to June 2026
- 21 in the 12 months before
- 99.8%
- marked serious by the reporter
- 91.7% across the class
- 4.6%
- record death among outcomes, as reported
- 163 reports · not verified by FDA
Between May 2021 and February 2026, 3,549 adverse event reports received by FDA list promethazine hydrochloride and codeine phosphate, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (4) are left out of every figure here.
In the 12 months to June 2026, 6 reports listed it, down 71% from 21 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 687 reports a year and 0% of the 20,646,523 reports in the database, and 0.4% of the reports for the opioid agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are dependence (98.4%), overdose (19.1%) and back pain (11.8%). A report can list several reactions, so shares add to more than 100%; 213 different terms appear across these reports. Dependence is recorded in 98.4% of these reports, a larger share than in the median opioid agonist drug (0.9%).
99.8% of the reports are marked serious by the reporter (91.7% across the class); 4.6% record death among the outcomes and 0.1% record hospitalisation, as reported. 99.9% of the reports came from consumers, and the largest patient age group is 18 to 44 (0.1%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Promethazine hydrochloride and codeine phosphate reports recording the termmedian drug in opioid agonist
- Dependence98.4%3,493
- Overdosea dose above the recommended amount19.1%677
- Back painback pain11.8%420
- Back injury6.7%238
- Painpain, site not specified4.6%163
- Deaththe patient died; cause not stated by this term4.4%157
- Arthralgiajoint pain3.3%118
- Road traffic accidenta road accident2.4%84
- Ill-defined disordera condition that was not clearly described2.2%77
- Spinal operation2.2%77
- Neck painneck pain1.8%65
- Pain in extremitypain in an arm or leg1.5%54
- Intervertebral disc protrusiona bulging spinal disc1.4%48
- Joint injury1.4%48
- Withdrawal syndrome1.3%45
- Anxietyanxiety1.2%44
- Depressionlow mood1.2%43
- Arthritis1%37
- Knee operation1%34
- Limb injury1%34
- Neck injury0.9%32
- Spinal cord injury0.9%32
- Injurya physical injury0.8%28
- Fibromyalgia0.7%26
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine0.7%25
- Headachehead pain0.6%23
- Spinal fracturea broken bone in the spine0.6%21
- Migrainemigraine0.5%19
Top 30 of 213 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 42 drugs in the opioid agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 965,051 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.9% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Pain | 6 | 0.2% |
| Cough | 2 | 0.1% |
The indication field is filled in by the reporter and is often blank; shares are of all 3,549 reports.
In context
| Measure | Promethazine hydrochloride and codeine phosphate | Opioid agonist | All reports |
|---|---|---|---|
| Reports as suspect product | 3,549 | 965,051 | 20,646,523 |
| Share of that pool | — | 0.4% | 0% |
| Reports, latest 12 months | 6 | — | 1,332,454 |
| Marked serious | 99.8% | 91.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 46 | 357 | 91 |
| Hospitalisation recorded, per 1,000 reports | 1 | 126 | 213 |
| Consumer-filed share | 99.9% | 32.5% | 45.8% |
| Top term, share of reports | Dependence 98.4% | median 0.9% | 0.3% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the opioid agonist class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| OxyContin | brand | 146,263 | 584 | 94.6% |
| Oxycodone hydrochloride | generic | 113,220 | 2,598 | 94.7% |
| Dilaudid | brand | 64,191 | 173 | 95.7% |
| Morphine sulfate | generic | 60,092 | 1,577 | 79.8% |
| Hydrocodone bitartrate and acetaminophen | generic | 59,052 | 170 | 96.2% |
| Percocet | brand | 57,793 | 198 | 95.4% |
| Fentanyl | generic | 53,656 | 3,292 | 86.2% |
| MS Contin | brand | 52,128 | 55 | 98.7% |
| Oxycodone | generic | 35,671 | 2,853 | 91.8% |
| Hysingla ER | brand | 30,703 | 6 | 92.1% |
| Morphine | generic | 28,421 | 1,421 | 90.5% |
| Nucynta | brand | 27,575 | 127 | 90.4% |
| Tramadol hydrochloride | generic | 27,447 | 1,952 | 92.4% |
| Oxycodone and acetaminophen | generic | 24,919 | 112 | 94% |
| Norco | brand | 24,661 | 42 | 93.1% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Promethazine hydrochloride and codeine phosphate reports
How many adverse event reports has FDA received for Promethazine hydrochloride and codeine phosphate?
3,549 reports list Promethazine hydrochloride and codeine phosphate as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 6 of them arrived in the latest 12 months. Another 4 list it only as a concomitant medication.
What reactions are recorded in Promethazine hydrochloride and codeine phosphate reports?
dependence (98.4%), overdose (19.1%), back pain (11.8%), back injury (6.7%) and pain (4.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Promethazine hydrochloride and codeine phosphate was responsible.
How serious are the reports?
99.8% are marked serious by the reporter. Among the outcomes recorded, 4.6% of reports include death and 0.1% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (99.9%) and other health professional (0.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Promethazine hydrochloride and codeine phosphate rising?
6 reports in the 12 months to June 2026, down 71% from 21 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Promethazine hydrochloride and codeine phosphate was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Promethazine hydrochloride and codeine phosphate?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Promethazine hydrochloride and codeine phosphate as a suspect or interacting product; reports listing it only as a concomitant medication (4) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.