Rocephin adverse event reports that FDA received

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

Name type: Product name as reported

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 4,220 adverse event reports that name Rocephin. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 3,993 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 55 reports in the 12 months to June 2026 and 79 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, 55 (under 0.1%) name Rocephin. Reports from consumers or other non-health professionals were 20.6% of the reports that name Rocephin and 45.8% 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 Rocephin 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 9 reports that name Rocephin.
In January to March 2026, FDA received 16.
In April to June 2025, FDA received 17.

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 354 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 all 4,220 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 354 terms.

Reaction terms in the reports that name Rocephin, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,220 reports
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	266	6.3%
Pyrexiafever	266	6.3%
Rashskin rash	253	6%
Dyspnoeashortness of breath	184	4.4%
Pruritusitching	164	3.9%
Renal failure acute	144	3.4%
Toxic epidermal necrolysisa severe skin reaction with peeling	143	3.4%
Diarrhoealoose or frequent stools	141	3.3%
Thrombocytopenialow platelets	139	3.3%
Nauseafeeling sick	136	3.2%
Cholelithiasisgallstones	131	3.1%
Erythemaskin redness	131	3.1%
Urticariahives	128	3%
Anaphylactic shocka severe allergic reaction with collapse	114	2.7%
Vomitingbeing sick	109	2.6%
Hypersensitivityan allergic-type reaction	100	2.4%
Drug interactionan interaction between medicines	90	2.1%
Pneumonialung infection	85	2%
Off label useused for a purpose or in a way not on the label	83	2%
Condition aggravatedthe condition being treated got worse	82	1.9%
Renal failurekidney failure	82	1.9%
Drug ineffectivethe medicine did not work as expected	81	1.9%
Stevens-Johnson syndromea severe skin and mucous-membrane reaction	80	1.9%
Sepsisa severe body-wide response to infection	79	1.9%
Clostridium difficile colitisa bowel infection with C. difficile	78	1.8%
Pancytopenialow counts of all blood cells	78	1.8%
Chillschills or shivering	73	1.7%
Anaphylactic reactiona severe, sudden allergic reaction	72	1.7%
Hepatic function abnormal	72	1.7%
Anaemialow red blood cells	71	1.7%
Hypotensionlow blood pressure	70	1.7%
Cytolytic hepatitis	66	1.6%
Deaththe patient died; cause not stated by this term	66	1.6%
Confusional stateconfusion	65	1.5%
Agranulocytosis	62	1.5%
Eosinophilia	59	1.4%
Dermatitis exfoliative	58	1.4%
Alanine aminotransferase increasedraised liver enzyme (ALT)	57	1.4%
Aspartate aminotransferase increasedraised liver enzyme (AST)	56	1.3%
Cholestasis	56	1.3%
Cough	56	1.3%
International normalised ratio increasedblood clotting slower than intended (raised INR)	56	1.3%
Rash maculo-papulara rash of flat and raised spots	56	1.3%
Cardiac arrestthe heart stopped	55	1.3%
Respiratory failurethe lungs could not supply enough oxygen	55	1.3%
Arthralgiajoint pain	54	1.3%
Dizzinesslight-headedness or unsteadiness	54	1.3%
Hepatocellular injury	54	1.3%
Septic shockshock arising from infection	54	1.3%
Shockshock, a collapse of the circulation	53	1.3%

Download all 354 terms of Rocephin (CSV)

The counts add to more than 4,220 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.

Outcomes by year

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

Outcomes in the reports that name Rocephin, 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	282	270	36	46	138	6	0	68	12
2005	235	229	27	29	139	8	0	54	6
2006	232	230	29	26	140	2	0	62	2
2007	242	234	39	31	134	5	0	64	8
2008	275	271	57	32	174	5	0	71	4
2009	253	243	46	34	158	6	1	57	10
2010	296	290	38	38	200	5	1	92	6
2011	238	235	32	29	147	4	0	77	3
2012	352	345	46	40	194	6	3	139	7
2013	155	139	21	20	83	0	0	53	16
2014	176	157	13	24	88	5	0	78	19
2015	180	156	29	25	78	14	0	59	24
2016	271	226	15	31	103	10	0	118	45
2017	394	240	13	28	88	7	1	138	154
2018	88	61	26	16	48	0	0	40	27
2019	105	70	14	17	43	0	1	46	35
2020	70	61	6	5	37	1	0	36	9
2021	93	78	17	14	31	0	0	64	15
2022	42	36	4	4	9	2	0	22	6
2023	64	57	3	11	38	2	0	37	7
2024	73	67	12	8	44	3	0	37	6
2025	75	62	10	18	33	2	0	32	13
2026	29	29	4	3	23	1	0	17	0

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 Rocephin, 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 Rocephin, by the year in which FDA received them
Year	Reports
2004	239
2005	238
2006	251
2007	251
2008	282
2009	251
2010	307
2011	241
2012	387
2013	158
2014	174
2015	173
2016	273
2017	385
2018	111
2019	85
2020	76
2021	79
2022	33
2023	59
2024	72
2025	69
2026	25

Reports that name Rocephin, 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 Rocephin
Age	Reports	Share
Under 2	133	3.2%
2 to 11	242	5.7%
12 to 17	96	2.3%
18 to 44	514	12.2%
45 to 64	755	17.9%
65 to 74	565	13.4%
75 and over	782	18.5%
Age not given	1,133	26.8%

Sex of the patient in the reports that name Rocephin
Sex	Reports	Share
Female	2,183	51.7%
Male	1,812	42.9%
Unknown or not given	225	5.3%

Type of reporter in the reports that name Rocephin
Reporter	Reports	Share
Physician	1,536	36.4%
Pharmacist	340	8.1%
Other health professional	1,261	29.9%
Lawyer	15	0.4%
Consumer or non-health professional	871	20.6%
Not given	197	4.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 24.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Rocephin record
Indication as recorded (MedDRA)	Reports	Share
Pneumonia	293	6.9%
Infection	177	4.2%
Urinary tract infection	160	3.8%
Bronchitis	106	2.5%
Pyrexia	87	2.1%
Lung infection	59	1.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,220 reports.

Drugs in the same reports

Other drugs that the reports of Rocephin name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	200
Aspirin	183
Bactrim	115
Flagyl	236
Furosemide	138
Lasix	254
Nexium	186
Omeprazole	140
Sodium chloride	198
Vancomycin	180

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

Rocefin next in the A to Z list
Rocephine next in the A to Z list
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Rofecoxib next in the A to Z list
Roactemra next in the A to Z list
Roferon-A next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for RocephinThe 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. Rocephin: adverse event reports that FDA received. https://reportedreactions.com/drug/rocephin/ 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 Rocephin as a suspect or interacting product. The 3,993 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 Rocephin 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 Rocephin?

No. It is a count of what people reported to FDA: 4,220 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?

Physician (36.4%), other health professional (29.9%) and consumer or non-health professional (20.6%). 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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