Pharmacologic class (EPC) · 2 drug pages

Phosphodiesterase 3 inhibitor: adverse event reports filed with FDA

2,669 reports list a drug in this class as a suspect or interacting product, 2004–2026.

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.

2,669
reports across the class: 0% of all reports; 944
reports, 12 months to June 2026: 275 in the 12 months before; 65.3%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Phosphodiesterase 3 inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 2,669 adverse event reports received by FDA, 0% of the database, from February 2004 to June 2026.

944 reports arrived in the 12 months to June 2026, up 243% from 275 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 65.3% of the class's reports are marked serious, 11.5% record death among the outcomes and 34.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are dyspnoea (9.8%), drug ineffective (4.7%) and diarrhoea (4.3%). 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
Cilostazol	generic	1,512	31	89%	Drug interaction
OhtuvayreEnsifentrine	brand	1,157	913	34.4%	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

Dyspnoeashortness of breath9.8%261
Drug ineffectivethe medicine did not work as expected4.7%125
Diarrhoealoose or frequent stools4.3%116
Headachehead pain3.5%93
Back painback pain3.2%86
Drug interactionan interaction between medicines3%81
Deaththe patient died; cause not stated by this term2.8%76
Dizzinesslight-headedness or unsteadiness2.8%74
Pneumonialung infection2.5%68
Nauseafeeling sick2.5%66
Vomitingbeing sick2%54
Atrial fibrillationan irregular heart rhythm1.9%52
Palpitationsawareness of the heartbeat1.9%52
Product dose omission issuea dose was missed1.8%48
Tachycardiafast heart rate1.8%47
Anaemialow red blood cells1.7%46
Hypertensionhigh blood pressure1.7%46
Condition aggravatedthe condition being treated got worse1.7%45
Depressionlow mood1.7%45
Hypotensionlow blood pressure1.7%45
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease1.6%44
Coughcough1.6%44
Chest painchest pain1.6%43
Astheniaweakness or lack of energy1.5%41
Falla fall1.5%41

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death11.5%308

Life-threatening5.7%151

Hospitalisation (initial or prolonged)34.8%930

Disability1.5%41

Congenital anomaly0%1

Other serious34.3%916

Not serious34.7%926

Patient age

Under 20.1%3

2 to 110.2%5

12 to 170.1%2

18 to 442%53

45 to 6412.3%329

65 to 7421.5%575

75 and over27.5%733

Age not given36.3%969

Who reported

Physician25.9%690

Pharmacist5.8%155

Other health professional20.8%554

Lawyer0%1

Consumer or non-health professional34.6%924

Not given12.9%345

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 3 inhibitor reports

Which drugs are in the Phosphodiesterase 3 inhibitor class on this site?

Cilostazol and Ohtuvayre. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

2,669 reports through June 2026, 944 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?

dyspnoea (9.8%), drug ineffective (4.7%), diarrhoea (4.3%), headache (3.5%) and back pain (3.2%).

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.