Pamidronate disodium adverse event reports that FDA received

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

Name type: Generic name
Class: Bisphosphonate
Also reported as: Pamidronate Disodium Injection, Pamidronate Disodium For Injection

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 2,136 adverse event reports that name Pamidronate disodium. In these reports the drug is a suspect or interacting product.

In the same period, 1,258 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 32 reports in the 12 months to June 2026 and 32 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, 32 (under 0.1%) name Pamidronate disodium. Reports from consumers or other non-health professionals were 10.3% of the reports that name Pamidronate disodium 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 Pamidronate disodium 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 13 reports that name Pamidronate disodium.
In January to March 2026, FDA received 6.
In April to June 2025, FDA received 3.

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 289 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 2,121 of the 2,136 reports (99.3%).

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 289 terms.

Reaction terms in the reports that name Pamidronate disodium, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,136 reports
Osteonecrosis	518	24.3%
Osteonecrosis of jawdeath of jaw bone tissue	425	19.9%
Painpain, site not specified	374	17.5%
Bone disorder	165	7.7%
Tooth extraction	162	7.6%
Impaired healingslow healing	105	4.9%
Pain in jaw	103	4.8%
Infectionan infection, type not specified	93	4.4%
Malignant neoplasm progression	92	4.3%
Drug ineffectivethe medicine did not work as expected	87	4.1%
Off label useused for a purpose or in a way not on the label	74	3.5%
Osteomyelitis	72	3.4%
Pyrexiafever	72	3.4%
Femur fracture	71	3.3%
Weight decreasedweight loss	68	3.2%
Nauseafeeling sick	62	2.9%
Deaththe patient died; cause not stated by this term	61	2.9%
Metastases to bone	61	2.9%
Bone debridement	55	2.6%
Fatiguetiredness	55	2.6%
Bone pain	54	2.5%
Anxiety	53	2.5%
Back pain	52	2.4%
Breast cancer	52	2.4%
Sequestrectomy	51	2.4%
Oedema peripheralswelling of the legs, ankles or hands	49	2.3%
Hypocalcaemialow blood calcium	44	2.1%
Hypophagia	44	2.1%
Pain in extremitypain in an arm or leg	43	2%
Arthralgiajoint pain	41	1.9%
Actinomycosis	40	1.9%
Atypical femur fracture	40	1.9%
Malaisegeneral feeling of being unwell	40	1.9%
Neoplasm progression	39	1.8%
Headachehead pain	38	1.8%
Drug intolerancethe medicine was not tolerated	36	1.7%
Jaw disorder	36	1.7%
Overdosea dose above the recommended amount	36	1.7%
Astheniaweakness or lack of energy	34	1.6%
Toothachetooth pain	34	1.6%
Blood creatinine increasedraised creatinine, a kidney test	32	1.5%
Debridement	32	1.5%
Acute generalised exanthematous pustulosis	31	1.5%
Chest pain	31	1.5%
Decreased appetitereduced appetite	31	1.5%
Hypercalcaemiahigh blood calcium	31	1.5%
Primary sequestrum	31	1.5%
Deformity	30	1.4%
Falla fall	30	1.4%
Hypoaesthesianumbness	30	1.4%

Download all 289 terms of Pamidronate disodium (CSV)

The counts add to more than 2,136 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 Pamidronate disodium, 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	118	99	11	1	18	7	2	72	19
2005	143	122	10	4	16	19	0	102	21
2006	102	98	16	3	11	6	0	88	4
2007	123	118	6	0	21	5	0	100	5
2008	133	130	5	4	18	13	0	114	3
2009	185	184	12	0	27	42	0	152	1
2010	326	325	11	1	20	192	0	292	1
2011	142	140	15	5	36	3	0	112	2
2012	90	89	7	1	11	2	0	80	1
2013	33	33	4	0	11	7	0	20	0
2014	25	25	8	1	9	1	0	20	0
2015	18	18	1	0	10	1	0	7	0
2016	27	27	0	0	5	1	0	23	0
2017	56	55	0	0	16	0	0	47	1
2018	66	65	6	4	17	4	0	45	1
2019	122	121	22	4	27	3	0	97	1
2020	104	104	12	5	20	1	0	89	0
2021	78	75	14	1	16	4	0	61	3
2022	57	56	0	2	26	1	0	43	1
2023	65	63	1	11	23	0	0	51	2
2024	68	68	14	8	19	0	0	50	0
2025	28	28	6	1	8	0	0	21	0
2026	27	27	0	1	16	0	0	18	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 Pamidronate disodium, 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 Pamidronate disodium, by the year in which FDA received them
Year	Reports
2004	76
2005	153
2006	128
2007	100
2008	123
2009	190
2010	334
2011	161
2012	123
2013	33
2014	21
2015	15
2016	25
2017	58
2018	74
2019	146
2020	111
2021	63
2022	52
2023	49
2024	62
2025	20
2026	19

Reports that name Pamidronate disodium, 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 Pamidronate disodium
Age	Reports	Share
Under 2	22	1%
2 to 11	77	3.6%
12 to 17	32	1.5%
18 to 44	98	4.6%
45 to 64	602	28.2%
65 to 74	372	17.4%
75 and over	244	11.4%
Age not given	689	32.3%

Sex of the patient in the reports that name Pamidronate disodium
Sex	Reports	Share
Female	1,201	56.2%
Male	711	33.3%
Unknown or not given	224	10.5%

Type of reporter in the reports that name Pamidronate disodium
Reporter	Reports	Share
Physician	401	18.8%
Pharmacist	104	4.9%
Other health professional	998	46.7%
Lawyer	219	10.3%
Consumer or non-health professional	219	10.3%
Not given	195	9.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 28% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Pamidronate disodium record
Indication as recorded (MedDRA)	Reports	Share
Multiple myeloma	248	11.6%
Metastases to bone	150	7%
Breast cancer	111	5.2%
Hypercalcaemia	102	4.8%
Osteoporosis	100	4.7%
Osteogenesis imperfecta	71	3.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,136 reports.

Drugs in the same reports

Other drugs that the reports of Pamidronate disodium name, in any role, in order of name
Drug	Reports that name the two
Afinitor	62
Cyclophosphamide	87
Dexamethasone	179
Ergocalciferol	66
Exemestane	67
Letrozole	88
Prednisone	91
Thalidomide	104
Zoledronic acid	312
Zometa	195

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

Ibandronate sodium same class
Reclast same class
Fosamax same class
Risedronate sodium same class
Atelvia same class
Zoledronic acid same class
Pamidronate next in the A to Z list
Pamidronic acid next in the A to Z list
Pamelor next in the A to Z list
Panadol next in the A to Z list
Palynziq next in the A to Z list
Panaldine next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Pamidronate disodiumThe 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. Pamidronate disodium: adverse event reports that FDA received. https://reportedreactions.com/drug/pamidronate-disodium/ 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 Pamidronate disodium as a suspect or interacting product. The 1,258 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 Pamidronate disodium 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 Pamidronate disodium?

No. It is a count of what people reported to FDA: 2,136 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 (46.7%), physician (18.8%) and lawyer (10.3%). 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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