Pulmonary toxicity adverse event reports that record this term

Kind of term: MedDRA preferred term

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.

Reports on file

From January 2004 to June 2026, FDA received 6,911 adverse event reports that record the MedDRA preferred term Pulmonary toxicity. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 635 reports in the 12 months to June 2026 and 605 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 855 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 635 (under 0.1%) record this term. Reports for female patients were 39.8% of the reports that record this term and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

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

Drugs in these reports

The table has the 138 drug pages with 25 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

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.

Drugs that the reports with the term Pulmonary toxicity name as a suspect product, in order of name
Drug	Class	Reports with this term
Abraxane	Microtubule inhibitor	54
Acetaminophen		44
Acetaminophen Oxycodone Hydrochloride		35
Actemra	Interleukin-6 receptor antagonist	383
Adalimumab	Tumor necrosis factor blocker	54
Adcetris	CD30-directed immunoconjugate	37
Afinitor	Kinase inhibitor	34
Alendronate sodium	Bisphosphonate	38
Alendronic Acid		35
Allopurinol	Xanthine oxidase inhibitor	38
Alunbrig	Kinase inhibitor	25
Amiodarone		418
Amiodarone hcl		234
Amiodarone hydrochloride	Antiarrhythmic	348
Amiodarone Teva		98
Amiodarone Zydus		98
Amitriptyline		42
Amoxicillin	Penicillin-class antibacterial	38
Arava	Antirheumatic agent	259
Arikayce	Aminoglycoside antibacterial	40
Atezolizumab	Programmed death Receptor-1 blocking antibody	39
Azathioprine	Purine antimetabolite	51
Bactrim	Dihydrofolate reductase inhibitor antibacterial	41
Benzalkonium chloride	Standardized chemical allergen	91
Bevacizumab	Vascular endothelial growth factor inhibitor	62
Bleomycin	Cytoprotective agent	237
Bleomycin sulfate	Cytoprotective agent	160
Bortezomib	Proteasome inhibitor	29
Busulfan	Alkylating drug	49
Cabometyx	Kinase inhibitor	27
Capecitabine	Nucleoside metabolic inhibitor	42
Carboplatin	Platinum-based drug	226
Carmustine	Alkylating drug	28
Celecoxib	Nonsteroidal anti-inflammatory drug	39
Cimzia	Tumor necrosis factor blocker	128
Ciprofloxacin	Fluoroquinolone antibacterial	26
Cisplatin	Platinum-based drug	150
Cordarone		63
Cyclophosphamide	Alkylating drug	302
Cytarabine	Nucleoside metabolic inhibitor	79
Dacarbazine	Alkylating drug	156
Daptomycin		45
Dasatinib	Kinase inhibitor	36
Depo-Medrol	Corticosteroid	30
Dexamethasone	Corticosteroid	96
Diphenhydramine hydrochloride	Histamine-1 receptor antagonist	63
Docetaxel	Microtubule inhibitor	131
Doxorubicin	Anthracycline topoisomerase inhibitor	185
Doxorubicin hydrochloride	Anthracycline topoisomerase inhibitor	161
Doxycycline	Tetracycline-class drug	29
Durvalumab	Programmed death Ligand-1 blocker	39
Enbrel	Tumor necrosis factor blocker	291
Enfortumab vedotin		73
Enhertu		77
Esomeprazole	Proton pump inhibitor	25
Esomeprazole Magnesium Naproxen		30
Etoposide	Topoisomerase inhibitor	183
Everolimus	Kinase inhibitor	31
Filgrastim	Leukocyte growth factor	30
Fluorouracil	Nucleoside metabolic inhibitor	89
Fosamax	Bisphosphonate	34
Furosemide	Loop diuretic	30
Gemcitabine	Nucleoside metabolic inhibitor	125
Gemcitabine hydrochloride	Nucleoside metabolic inhibitor	48
Gemzar		54
Gold	Standardized chemical allergen	199
Gold Sodium Thiomalate		41
Herceptin	HER2/neu receptor antagonist	35
Human immunoglobulin g	Human immunoglobulin G	35
Humira		312
Hydroxychloroquine	Antimalarial	234
Hydroxychloroquine sulfate	Antimalarial	210
Ibrance	Kinase inhibitor	47
Ifosfamide	Alkylating drug	26
Imatinib	Kinase inhibitor	27
Imfinzi	Programmed death Ligand-1 blocker	94
Imuran	Purine antimetabolite	26
Ipilimumab	CTLA-4-directed blocking antibody	39
Keytruda	Programmed death Receptor-1 blocking antibody	263
Leflunomide	Antirheumatic agent	221
Lenvima	Kinase inhibitor	35
Levetiracetam		25
Lynparza	Poly(ADP-Ribose) polymerase inhibitor	28
Lyrica		37
Meloxicam	Nonsteroidal anti-inflammatory drug	158
Melphalan	Alkylating drug	53
Methotrexate	Folate analog metabolic inhibitor	692
Methotrexate sodium	Folate analog metabolic inhibitor	177
Methylprednisolone	Corticosteroid	35
Methylprednisolone acetate	Corticosteroid	33
Methylprednisolone sodium succinate	Corticosteroid	27
Mobicox		66
Multaq	Antiarrhythmic	31
Mycophenolate mofetil	Antimetabolite immunosuppressant	48
Naproxen	Nonsteroidal anti-inflammatory drug	40
Nitrofurantoin	Nitrofuran antibacterial	101
Nivolumab	Programmed death Receptor-1 blocking antibody	114
Opdivo	Programmed death Receptor-1 blocking antibody	151
Orencia	Selective T cell costimulation modulator	350
Oxaliplatin	Platinum-based drug	124
Pacerone	Antiarrhythmic	38
Paclitaxel	Microtubule inhibitor	190
Pantoprazole	Proton pump inhibitor	49
Pantoprazole sodium	Proton pump inhibitor	39
Pegfilgrastim	Leukocyte growth factor	52
Pembrolizumab	Programmed death Receptor-1 blocking antibody	112
Pemetrexed	Folate analog metabolic inhibitor	81
Phenylephrine hydrochloride	alpha-1 adrenergic agonist	80
Plaquenil	Antimalarial	69
Prednisolone	Corticosteroid	58
Prednisone	Corticosteroid	291
Pregabalin		34
Procarbazine hydrochloride	Alkylating drug	29
Ranitidine	Histamine-2 receptor antagonist	33
Remicade	Tumor necrosis factor blocker	76
Revlimid	Thalidomide analog	39
Rituxan	CD20-directed cytolytic antibody	64
Rituximab	CD20-directed cytolytic antibody	422
Septra		38
Simponi	Tumor necrosis factor blocker	133
Simvastatin	HMG-CoA reductase inhibitor	38
Sirolimus	Kinase inhibitor	77
Sulfamethoxazole, trimethoprim	Dihydrofolate reductase inhibitor antibacterial	52
Sulfasalazine	Aminosalicylate	249
Tacrolimus	Calcineurin inhibitor immunosuppressant	76
Tagrisso	Kinase inhibitor	40
Taxotere		26
Tecentriq	Programmed death Receptor-1 blocking antibody	52
Tofacitinib	Janus kinase inhibitor	57
Tofacitinib citrate	Janus kinase inhibitor	60
Trastuzumab	HER2/neu receptor antagonist	46
Trimethoprim	Dihydrofolate reductase inhibitor antibacterial	38
Velcade	Proteasome inhibitor	28
Vinblastine		90
Vinblastine sulfate	Vinca alkaloid	60
Vincristine		210
Xeljanz	Janus kinase inhibitor	106
Yervoy	CTLA-4-directed blocking antibody	87

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 56 pharmacologic classes with 25 or more reports that record this term. The rows are in order of name.

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.

Pharmacologic classes of the drugs that the reports with the term Pulmonary toxicity name, in order of name
Class	Reports with this term
Alkylating drug	670
alpha-1 adrenergic agonist	99
Aminoglycoside antibacterial	49
Aminosalicylate	277
Anthracycline topoisomerase inhibitor	366
Antiarrhythmic	401
Antimalarial	513
Antimetabolite immunosuppressant	50
Antirheumatic agent	480
Aromatase inhibitor	27
Atypical antipsychotic	26
Bisphosphonate	80
Calcineurin inhibitor immunosuppressant	101
CD20-directed cytolytic antibody	486
CD30-directed immunoconjugate	54
Corticosteroid	598
CTLA-4-directed blocking antibody	155
Cytoprotective agent	401
Dihydrofolate reductase inhibitor antibacterial	155
Epidermal growth factor receptor antagonist	50
Factor Xa inhibitor	35
Fluoroquinolone antibacterial	48
Folate analog	41
Folate analog metabolic inhibitor	974
HER2/neu receptor antagonist	99
Histamine-1 receptor antagonist	70
Histamine-2 receptor antagonist	53
HMG-CoA reductase inhibitor	65
Human immunoglobulin G	45
Interleukin-6 receptor antagonist	403
Janus kinase inhibitor	240
Kinase inhibitor	626
Leukocyte growth factor	106
Loop diuretic	30
Microtubule inhibitor	375
Nitrofuran antibacterial	101
Nonsteroidal anti-inflammatory drug	277
Nucleoside metabolic inhibitor	461
Opioid agonist	42
Penicillin-class antibacterial	40
Platinum-based drug	500
Poly(ADP-Ribose) polymerase inhibitor	40
Programmed death Ligand-1 blocker	138
Programmed death Receptor-1 blocking antibody	733
Proteasome inhibitor	77
Proton pump inhibitor	142
Purine antimetabolite	96
Selective T cell costimulation modulator	354
Standardized chemical allergen	201
Tetracycline-class drug	41
Thalidomide analog	78
Topoisomerase inhibitor	232
Tumor necrosis factor blocker	730
Vascular endothelial growth factor inhibitor	86
Vinca alkaloid	83
Xanthine oxidase inhibitor	38

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Pulmonary toxicity, 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.

Patients in these reports

Age of the patient in the reports that record Pulmonary toxicity
Age	Reports	Share
Under 2	23	0.3%
2 to 11	81	1.2%
12 to 17	53	0.8%
18 to 44	558	8.1%
45 to 64	1,237	17.9%
65 to 74	1,457	21.1%
75 and over	1,246	18%
Age not given	2,256	32.6%

Sex of the patient in the reports that record Pulmonary toxicity
Sex	Reports	Share
Female	2,754	39.8%
Male	2,937	42.5%
Unknown or not given	1,220	17.7%

Age and sex are as the report gives them. 37.1% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

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. Pulmonary toxicity: adverse event reports that record this term. https://reportedreactions.com/reaction/pulmonary-toxicity/ 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.

The count has the reports with each spelling of one MedDRA preferred term. 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

What does Pulmonary toxicity mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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