Codeine phosphate adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Codeine phosphate
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Also reported as: Codeine Phosphate Injection, Codeine Phosphate /00012605/

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 2,321 adverse event reports that name Codeine phosphate. In these reports the drug is a suspect or interacting product.

In the same period, 6,256 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 126 reports in the 12 months to June 2026 and 191 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 126 (under 0.1%) name Codeine phosphate. Reports from other health professionals were 48% of the reports that name Codeine phosphate and 19.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Codeine phosphate is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 33 reports that name Codeine phosphate.
In January to March 2026, FDA received 20.
In April to June 2025, FDA received 35.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 615 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 2,273 of the 2,321 reports (97.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 615 terms.

Reaction terms in the reports that name Codeine phosphate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,321 reports
Nauseafeeling sick	501	21.6%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	484	20.9%
Headachehead pain	440	19%
Drug ineffectivethe medicine did not work as expected	421	18.1%
Fatiguetiredness	409	17.6%
Diarrhoealoose or frequent stools	390	16.8%
Off label useused for a purpose or in a way not on the label	376	16.2%
Dyspnoeashortness of breath	356	15.3%
Dizzinesslight-headedness or unsteadiness	345	14.9%
Arthralgiajoint pain	341	14.7%
Vomitingbeing sick	320	13.8%
Malaisegeneral feeling of being unwell	306	13.2%
Pruritusitching	300	12.9%
Pyrexiafever	290	12.5%
Painpain, site not specified	283	12.2%
Abdominal painstomach or belly pain	263	11.3%
Hyperhidrosisexcessive sweating	263	11.3%
Astheniaweakness or lack of energy	235	10.1%
Hypersensitivityan allergic-type reaction	234	10.1%
Rashskin rash	230	9.9%
Abdominal pain upperupper stomach pain	229	9.9%
Insomniadifficulty sleeping	227	9.8%
Toxicity to various agentspoisoning or toxic effect of one or more substances	227	9.8%
Cough	224	9.7%
Decreased appetitereduced appetite	212	9.1%
Drug interactionan interaction between medicines	203	8.7%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	199	8.6%
Tachycardiafast heart rate	199	8.6%
Hypertensionhigh blood pressure	196	8.4%
Somnolencedrowsiness	196	8.4%
Product use in unapproved indicationused for a purpose not on the label	190	8.2%
Drug intolerancethe medicine was not tolerated	189	8.1%
Falla fall	180	7.8%
Urticariahives	177	7.6%
Blood pressure increaseda raised blood pressure reading	170	7.3%
Nightmarenightmares	167	7.2%
Chillschills or shivering	166	7.2%
Hepatic enzyme increasedraised liver enzymes	161	6.9%
Anxiety	160	6.9%
Overdosea dose above the recommended amount	159	6.9%
Eye pain	157	6.8%
Joint swellinga swollen joint	154	6.6%
Infusion related reactiona reaction during or soon after an infusion	151	6.5%
Contusiona bruise	146	6.3%
Asthma	145	6.2%
Haemorrhagic stroke	145	6.2%
Gait disturbancedifficulty walking	142	6.1%
Tinnitusringing in the ears	142	6.1%
Abdominal discomfortstomach discomfort	140	6%
Vision blurredblurred vision	140	6%

Download all 615 terms of Codeine phosphate (CSV)

The counts add to more than 2,321 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Codeine phosphate with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Codeine phosphate (this page)	Generic name	2,321
Codeine sulfate	Generic name	2,154

Sum of the separately reported names: 4,475. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Codeine phosphate, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	10	10	1	0	4	2	0	5	0
2005	8	8	0	2	5	1	1	1	0
2006	24	24	10	7	12	1	0	5	0
2007	6	6	0	0	6	0	0	0	0
2008	9	8	4	0	1	0	1	4	1
2009	32	32	2	4	18	0	1	12	0
2010	10	10	4	1	4	2	0	3	0
2011	12	12	1	1	6	1	2	5	0
2012	28	24	4	3	10	0	2	14	4
2013	59	51	13	9	9	4	0	27	8
2014	69	58	24	9	13	11	0	35	11
2015	66	44	15	2	16	1	0	26	22
2016	80	42	8	2	12	1	0	30	38
2017	47	29	11	4	7	2	0	15	18
2018	164	143	39	4	30	10	1	99	21
2019	215	182	26	8	43	10	0	137	33
2020	142	128	14	5	39	7	1	105	14
2021	125	119	21	16	41	16	1	96	6
2022	201	192	38	22	71	28	0	166	9
2023	273	266	60	24	91	21	4	240	7
2024	357	350	161	65	108	57	13	329	7
2025	216	213	86	40	75	32	17	196	3
2026	168	167	63	42	76	39	23	162	1

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Codeine phosphate, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Codeine phosphate, by the year in which FDA received them
Year	Reports
2004	9
2005	8
2006	24
2007	7
2008	10
2009	35
2010	9
2011	16
2012	38
2013	70
2014	81
2015	76
2016	96
2017	79
2018	222
2019	244
2020	153
2021	176
2022	198
2023	244
2024	334
2025	139
2026	53

Reports that name Codeine phosphate, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Codeine phosphate
Age	Reports	Share
Under 2	9	0.4%
2 to 11	7	0.3%
12 to 17	20	0.9%
18 to 44	623	26.8%
45 to 64	563	24.3%
65 to 74	241	10.4%
75 and over	194	8.4%
Age not given	664	28.6%

Sex of the patient in the reports that name Codeine phosphate
Sex	Reports	Share
Female	1,341	57.8%
Male	608	26.2%
Unknown or not given	372	16%

Type of reporter in the reports that name Codeine phosphate
Reporter	Reports	Share
Physician	573	24.7%
Pharmacist	76	3.3%
Other health professional	1,114	48%
Lawyer	10	0.4%
Consumer or non-health professional	515	22.2%
Not given	33	1.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 11.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Codeine phosphate record
Indication as recorded (MedDRA)	Reports	Share
Migraine	126	5.4%
Rheumatoid arthritis	95	4.1%
Pain	86	3.7%
Analgesic therapy	49	2.1%
Back pain	21	0.9%
Cough	14	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,321 reports.

Drugs in the same reports

Other drugs that the reports of Codeine phosphate name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	755
Adalimumab	297
Celecoxib	277
Codeine	327
Diclofenac sodium	292
Hydromorphone hydrochloride	304
Ibuprofen	358
Morphine	317
Pregabalin	347
Venlafaxine hydrochloride	356

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Codeine sulfate same ingredient
Codeine next in the A to Z list
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Codeine Sul Tab next in the A to Z list
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These links are for navigation. No count selected them.

Official pages

DailyMed labels for Codeine phosphateThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Codeine phosphate: adverse event reports that FDA received. https://reportedreactions.com/drug/codeine-phosphate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Codeine phosphate as a suspect or interacting product. The 6,256 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Codeine phosphate was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Codeine phosphate?

No. It is a count of what people reported to FDA: 2,321 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (48%), physician (24.7%) and consumer or non-health professional (22.2%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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