Pharmacologic class (EPC) · 5 drug pages

Phosphodiesterase 4 inhibitor: adverse event reports filed with FDA

152,432 reports list a drug in this class as a suspect or interacting product, 2010–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

152,432
reports across the class: 0.7% of all reports; 4,442
reports, 12 months to June 2026: 5,429 in the 12 months before; 23%
marked serious by the reporter: 57.4% across all reports; 5
drugs with a page: brand and generic names counted separately

Phosphodiesterase 4 inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 5 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 152,432 adverse event reports received by FDA, 0.7% of the database, from May 2010 to June 2026.

4,442 reports arrived in the 12 months to June 2026, down 18% from 5,429 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 23% of the class's reports are marked serious, 4.8% record death among the outcomes and 8.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are diarrhoea (16.5%), nausea (14.9%) and psoriasis (13%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
OtezlaApremilast	brand	135,710	3,344	20.6%	Diarrhoea
EucrisaCrisaborole	brand	7,751	92	5.1%	Drug ineffective
Apremilast	generic	5,247	880	77.5%	Off label use
DalirespRoflumilast	brand	2,443	14	58.4%	Death
Roflumilast	generic	1,281	112	92.7%	Dyspnoea

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Diarrhoealoose or frequent stools16.5%25,116
Nauseafeeling sick14.9%22,684
Psoriasispsoriasis, a skin condition13%19,832
Headachehead pain11.9%18,215
Drug ineffectivethe medicine did not work as expected11.2%17,005
Abdominal discomfortstomach discomfort5.6%8,511
Psoriatic arthropathy5.3%8,115
Rashskin rash4.8%7,332
Painpain, site not specified4.7%7,212
Vomitingbeing sick4.5%6,826
Off label useused for a purpose or in a way not on the label4.2%6,422
Fatiguetiredness4.2%6,387
Arthralgiajoint pain4.1%6,242
Depressionlow mood3.8%5,746
Weight decreasedweight loss3.6%5,451
Abdominal pain upperupper stomach pain3.3%5,032
Malaisegeneral feeling of being unwell3.2%4,909
Product dose omission issuea dose was missed3.1%4,772
Condition aggravatedthe condition being treated got worse3.1%4,690
Product dose omissiona dose was missed3%4,600
Pruritusitching2.9%4,487
Decreased appetitereduced appetite2.9%4,477
Therapy non-responderthe treatment did not work2.7%4,084
Dizzinesslight-headedness or unsteadiness2.5%3,797
Insomniadifficulty sleeping2.5%3,772

Solid bar: share of all class reports. Hollow bar: the median share across the 5 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death4.8%7,250

Life-threatening3.3%4,990

Hospitalisation (initial or prolonged)8.1%12,363

Disability3.7%5,671

Congenital anomaly1.5%2,228

Other serious17.4%26,454

Not serious77%117,361

Patient age

Under 20.2%283

2 to 110.8%1,174

12 to 170.4%683

18 to 4413.9%21,179

45 to 6426.9%41,061

65 to 748.9%13,625

75 and over4.1%6,195

Age not given44.8%68,232

Who reported

Physician15.8%24,059

Pharmacist14.9%22,715

Other health professional43.4%66,188

Lawyer0%4

Consumer or non-health professional24.7%37,654

Not given1.2%1,812

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Phosphodiesterase 4 inhibitor reports

Which drugs are in the Phosphodiesterase 4 inhibitor class on this site?

Otezla, Eucrisa, Apremilast, Daliresp and Roflumilast. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

152,432 reports through June 2026, 4,442 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

diarrhoea (16.5%), nausea (14.9%), psoriasis (13%), headache (11.9%) and drug ineffective (11.2%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.