Leukogram Patterns in Dogs and Cats: A Diagnostic Guide

By Dr. Zubair Khalid, DVM, MS, PhD · 2026-08-11

Key Takeaways

• The leukogram, a component of the complete blood count, is a critical diagnostic tool in small animal practice, with patterns categorized as physiologic (epinephrine-induced), stress (corticosteroid-induced), and inflammatory, each reflecting distinct bone marrow responses and circulating leukocyte dynamics.
• A physiologic leukogram, characterized by mild mature neutrophilia and lymphocytosis in dogs (neutrophils <20,000/µL) and cats (neutrophils <15,000/µL), is transient, resolving within 30 minutes of the inciting stimulus (e.g., excitement, exercise), and lacks a left shift or toxic change.
• The stress leukogram, indicative of sustained glucocorticoid effects, typically presents as moderate mature neutrophilia, lymphopenia, and eosinopenia in dogs, while cats may show milder neutrophilia and less consistent eosinopenia; monocytosis is common in both species.
• An inflammatory leukogram signifies bone marrow response to injury or infection, typically manifesting as marked neutrophilia (>30,000/µL) with a left shift and/or toxic change in dogs, whereas cats may exhibit more variable neutrophilia, with toxic change being a reliable indicator even with unremarkable total counts.
• Leukopenia necessitates a structured approach, beginning with smear review for toxic change and left shift, followed by assessment of neutrophil counts to differentiate causes such as overwhelming bacterial infection (degenerative left shift) from bone marrow suppression, with concurrent thrombocytopenia and anemia raising concern for pancytopenia.
• Species-specific interpretation is crucial, as cats have smaller circulating neutrophil pools and more pronounced marginated pools, leading to less dramatic neutrophilia during stress compared to dogs, and age significantly influences expected leukogram responses, with younger animals exhibiting more robust lymphocytosis.

The complete blood count is among the most frequently submitted laboratory tests in small animal practice, and the leukogram is its most information-dense component. This article provides a structured framework for interpreting leukocyte numbers and ratios in dogs and cats, with emphasis on recognizing the major pattern categories: physiologic, stress, and inflammatory. It serves the practicing veterinarian who needs to move from raw cell counts to a prioritized differential list and a rational next diagnostic step.

The interpretive approach presented here rests on three foundations: the bone marrow's capacity to respond to demand, the differential effects of endogenous and exogenous corticosteroids on circulating leukocyte populations, and the distinction between peripheral redistribution and true changes in total body granulocyte pools. Mastery of these principles allows the clinician to extract diagnostic value from even a single complete blood count, while recognizing when serial sampling or additional testing is required. The guide deliberately excludes detailed cytologic description of individual leukocyte types, focusing instead on pattern recognition and its clinical consequences.

At a Glance

Physiologic Leukogram

The physiologic leukogram results from acute epinephrine release and is most commonly observed in young, excited, or fractious animals during venipuncture. Epinephrine causes splenic contraction and demargination of the intravascular neutrophil pool, producing a mild mature neutrophilia and lymphocytosis. In dogs, the neutrophilia rarely exceeds 20,000 cells per microliter, and lymphocyte counts may double or triple from baseline. Cats show a similar but less pronounced response, with neutrophilia typically remaining below 15,000 cells per microliter.

The critical diagnostic feature is transience. Physiologic changes resolve within 20 to 30 minutes of the inciting stimulus, so a repeat blood sample obtained after the animal has been calm for an hour will show a normal leukogram. The absence of a left shift, toxic change, or monocytosis distinguishes this pattern from early inflammatory disease. Recognition of the physiologic pattern prevents unnecessary diagnostic investigation in anxious patients, but the clinician should remain alert to the possibility that excitement and early disease coexist. The health consequences of psychogenic stress in hospitalized dogs extend beyond transient hematologic shifts, and repeated stressful sampling can confound serial monitoring Hekman et al. on psychogenic stress in hospitalized dogs.

Stress Leukogram

The stress leukogram reflects sustained glucocorticoid effect on the bone marrow, circulating pool, and tissue margination. Endogenous cortisol release from any chronic illness, pain, or hospitalization can produce this pattern, as can exogenous glucocorticoid administration. The classic canine stress leukogram comprises mature neutrophilia, lymphopenia, eosinopenia, and often monocytosis. Neutrophil counts typically range from 15,000 to 30,000 cells per microliter, and the absence of a left shift is characteriztic because glucocorticoids increase marrow release of mature cells while suppressing the inflammatory response that would generate band neutrophils.

Cats present a more variable picture. Feline stress leukograms frequently show only mild neutrophilia and lymphopenia, and eosinopenia is less consistent than in dogs. Some stressed cats show no leukogram change at all, which makes the absence of a stress pattern unhelpful in ruling out disease. The distinction between stress and inflammatory leukograms becomes clinically important because the former suggests a chronic or noninfectious process, while the latter raises concern for bacterial infection or tissue necrosis. Anesthetic and surgical stress produces a coordinated neuroendocrine and immunologic response that can amplify or obscure these hematologic changes in the perioperative period Hernández-Avalos et al. on anesthetic-surgical stress responses.

Inflammatory Leukogram

The inflammatory leukogram is the bone marrow's response to tissue injury, infection, or immune stimulation. In dogs, this pattern typically features neutrophilia exceeding 30,000 cells per microliter, often accompanied by a left shift, toxic change, or both. The magnitude of neutrophilia reflects both increased marrow production and prolonged circulating half-life. When demand exceeds marrow output, the neutrophil count may fall into the normal range or below, producing a degenerative left shift that signals a guarded prognosis.

Feline inflammatory responses differ substantially from canine patterns. Cats frequently mount a modest neutrophilia of 20,000 to 25,000 cells per microliter, and severe infections may produce only a normal or low neutrophil count with a left shift. Toxic change in neutrophils is a reliable indicator of an active inflammatory process in both species, even when the total count is unremarkable. Cytauxzoonosis exemplifies a feline disease in which hematologic changes may be subtle or nonspecific early in the course, and the diagnosis often rests on identification of parasitic inclusions within erythrocytes instead of on the leukogram pattern alone Sherrill and Cohn on cytauxzoonosis diagnosis.

Leukopenia and the Exhausted Marrow

Leukopenia represents either decreased marrow production, increased peripheral consumption, or sequestration. In dogs, the most common cause is overwhelming bacterial infection with endotoxemia, which produces a degenerative left shift with neutropenia. Feline leukopenia more frequently results from viral infection, particularly panleukopenia virus, or from bone marrow suppression. The distinction matters for therapeutic planning: neutropenia from consumption requires aggressive antimicrobial therapy, while neutropenia from marrow suppression may benefit from hematopoietic support and treatment of the underlying cause.

Pattern Integration and Diagnostic Prioritization

The leukogram must be interpreted as a whole, integrating neutrophil count, band neutrophil proportion, lymphocyte and eosinophil numbers, and the presence of toxic change. A mature neutrophilia with lymphopenia and eosinopenia in a dog with polyuria and polydipsia directs investigation toward hyperadrenocorticism. The same neutrophilia with a left shift and toxic change in a febrile dog directs attention to a septic focus. Serial leukograms add temporal information: a rising neutrophil count with resolving toxic change indicates appropriate response to therapy, while a falling count with persistent left shift suggests deterioration.

Reference intervals vary by laboratory and analyzer, and the American Society for Veterinary Clinical Pathology provides guidance on quality assurance and validation of hematologic methods that practitioners should consult when interpreting results from unfamiliar laboratories ASVCP quality assurance guidelines. Species-specific reference data and clinical decision support are available through standard professional references MSD Veterinary Manual.

Diagnostic Sequence for the Leukopenic Patient

The leukopenic patient requires a structured approach because the differential list is broad and the clinical stakes are high. Begin by confirming the finding on a fresh blood smear. Automated counts can be falsely low due to clumping, particularly in cats, or due to sample degeneration in aged blood. Examine the smear for toxic change, left shift, and intracellular organizms. A manual differential count is mandatory when the automated count is below the reference interval, because the distribution of remaining cells determines the next diagnostic step.

Assess the neutrophil count specifically. Neutropenia with concurrent lymphopenia suggests acute stress or glucocorticoid effect superimposed on a marrow insult. Neutropenia with lymphocytosis is unusual and should prompt evaluation for chronic infection or immune-mediated destruction. Monocytopenia is expected in the stressed patient, whereas monocytosis with neutropenia suggests marrow recovery or chronic inflammation.

Evaluate the platelet count and red cell indices concurrently. A leukopenic patient with thrombocytopenia and anemia raises concern for pancytopenia, which shifts the differential toward marrow failure, infectious disease, or neoplasia. Normal erythroid and megakaryocytic lines narrow the focus to neutrophil-specific processes such as immune-mediated destruction or drug reaction.

The next decision point is the bone marrow examination. Cytopenias of more than three days duration, progressive decline in counts, or the presence of concurrent cytopenias warrant marrow aspiration. Marrow evaluation distinguishes regenerative from non-regenerative responses and identifies neoplasia, myelofibrosis, or infectious agents. In cats, marrow evaluation is particularly important because retrovirus testing does not always predict marrow pathology.

Prioritizing Differentials for Leukocytosis

Leukocytosis is a common laboratory finding, but the pattern of the elevation directs the workup. The first step is to determine whether the elevation is neutrophilic, lymphocytic, monocytic, eosinophilic, or basophilic. Mixed elevations are common and should be interpreted by the dominant cell type.

Neutrophilic leukocytosis with a left shift and toxic change indicates an inflammatory leukogram. The priority is to locate the inflammatory focus. Fever, localized pain, or organ-specific signs guide imaging. If no localizing signs exist, thoracic and abdominal imaging, urine culture, and echocardiography are reasonable next steps. The absence of a left shift does not exclude inflammation, because chronic inflammation can produce mature neutrophilia without immature forms.

Neutrophilic leukocytosis without a left shift or toxic change in a patient receiving corticosteroids is consistent with a stress or glucocorticoid effect. The history should include topical, otic, or ophthalmic glucocorticoid exposure, because these routes can produce systemic effects. Endogenous hypercortisolism is a consideration when the pattern persists and clinical signs such as polyuria, polydipsia, and alopecia are present.

Lymphocytic leukocytosis is uncommon in dogs and cats. Persistent lymphocytosis in an older cat warrants testing for retrovirus infection, particularly feline leukemia virus. In dogs, chronic lymphocytic leukemia is the most common cause of a marked mature lymphocytosis. A lymphocytosis that is transient and resolves within hours is consistent with a physiologic leukogram, particularly in young animals.

Eosinophilia directs attention to parasitism, hypersensitivity, or mast cell disease. The geographic region determines which parasites are prioritized. Eosinophilic leukocytosis with basophilia raises suspicion for heartworm disease or gastrointestinal parasitism. Persistent eosinophilia without an identifiable cause warrants evaluation for eosinophilic gastrointestinal disease or mast cell neoplasia.

The following table summarizes the prioritization framework for leukocytosis based on the dominant cell type and accompanying findings.

Species Differences in Leukogram Interpretation

Dogs and cats differ in their baseline leukocyte biology, and these differences affect interpretation. Cats have smaller circulating neutrophil pools and a more pronounced marginated pool. Stress in cats produces a less dramatic neutrophilia than in dogs, and the lymphopenia of stress is often the more reliable indicator. Cats also demonstrate a unique pattern of corticosteroid-induced neutrophilia that is milder and shorter-lived than in dogs.

The feline stress leukogram frequently shows lymphopenia, eosinopenia, and a mild mature neutrophilia. The absence of a left shift is typical. A mature neutrophilia in a cat without lymphopenia should prompt consideration of inflammation instead of stress alone. The ASVCP quality assurance guidelines emphasize that reference intervals are species-specific and that laboratory methods must be validated for each species, which is particularly relevant when interpreting feline leukograms against canine-derived expectations.

Dogs exhibit a more robust neutrophilic response to both stress and inflammation. The magnitude of the neutrophilia can be striking, with counts exceeding 50,000 cells per microliter in severe inflammation. Dogs also develop a more pronounced left shift, and the presence of band neutrophils is a more reliable indicator of inflammation in dogs than in cats.

Age modifies the expected response. Young animals have larger thymic and lymphoid compartments, so physiologic lymphocytosis is more common in puppies and kittens. Geriatric patients may mount a blunted leukocyte response to inflammation, so a normal leukogram does not exclude significant disease in older animals.

Monitoring Parameters and Response Assessment

Serial leukogram evaluation is essential for monitoring treatment response and disease progression. The frequency of monitoring depends on the underlying condition and the expected time course of response. For bacterial infections, a leukogram should be repeated within 48 to 72 hours of initiating antimicrobial therapy. A rising neutrophil count with a resolving left shift and decreasing toxic change indicates appropriate therapy. A persistent left shift or worsening toxic change suggests treatment failure, resistant infection, or an undrained focus.

For patients receiving chemotherapy, the neutrophil count is the primary determinant of subsequent dosing. The nadir typically occurs 7 to 10 days after treatment, and the count must be above the threshold specified by the chemotherapy protocol before the next dose. The ASVCP guidelines for laboratory quality assurance support the use of validated reference intervals to determine whether a post-chemotherapy count is within the expected range for the patient.

For patients with immune-mediated neutropenia, the response to immunosuppressive therapy is monitored weekly initially. A rising neutrophil count with clinical improvement supports the treatment plan. Lack of response within 7 to 14 days should prompt reconsideration of the diagnosis or the addition of a second immunosuppressive agent.

The stress leukogram of hospitalized patients deserves specific attention. Hospitalization itself induces a stress response that can confound serial monitoring. The neurobiology of the anesthetic-surgical stress response includes measurable changes in cortisol and catecholamines that alter leukocyte distribution, and these effects can persist for days after the procedure. When monitoring a postoperative patient, the clinician must distinguish the expected surgical stress leukogram from a developing inflammatory complication. A persistent or increasing left shift, the appearance of toxic change, or a rising total neutrophil count beyond the expected postoperative peak should trigger investigation for infection. Recognition of psychogenic stress in hospitalized dogs is an important component of this assessment, because stress-induced immune dysfunction can increase susceptibility to nosocomial infection and delay recovery.

Documentation and Reporting

The leukogram interpretation should be documented in the medical record with the specific pattern identified, the differential list prioritized, and the planned diagnostic or therapeutic steps. Record the absolute cell counts, also the percentages, because relative values can be misleading when total counts are abnormal. Note the presence of toxic change, left shift, and any cellular abnormalities observed on smear review.

When the leukogram is equivocal, document the uncertainty and the planned recheck interval. A single abnormal leukogram is rarely diagnostic, and serial evaluation often provides more information than any single measurement. The record should reflect the clinical reasoning that connects the laboratory findings to the patient presentation, so that subsequent clinicians can follow the diagnostic logic without repeating the workup.

Laboratory quality assurance matters in this context. The ASVCP quality assurance guidelines address the validation of reference intervals and the importance of method-specific standards, and the clinician should be aware of the laboratory's methods when interpreting results. A leukogram generated by an impedance counter may differ from one generated by laser-based flow cytometry, and the reference intervals must match the method in use.

Recognized Complications and Failure Modes

The leukogram can mislead when the underlying process changes faster than the hematologic response. The most clinically significant failure mode is the transition from an inflammatory leukogram to leukopenia with a left shift, which signals consumption of the marrow reserve. Serial complete blood counts are the only reliable way to distinguish this progression from a static leukopenic state. A neutrophil count that falls by more than 30% between samples taken 12 to 24 hours apart warrants immediate reassessment of the primary diagnosis.

Toxic change in neutrophils, characterized by cytoplasmic basophilia, Döhle bodies, and foamy vacuolation, indicates concurrent endotoxemia or severe bacterial infection. Its presence should prompt blood culture and cytologic sampling of suspected foci even when the total neutrophil count remains within reference limits. Degenerative left shift, where band neutrophils exceed segmented neutrophils, carries a guarded prognosis and demands aggressive diagnostic pursuit.

The stress leukogram itself can obscure an inflammatory response. Endogenous corticosteroid release shifts neutrophils from the marginal pool into the circulating pool while simultaneously reducing egress into tissues. A dog with early sepsis may therefore show a stress pattern instead of the expected neutrophilia with left shift. Repeating the count after 12 hours or evaluating additional markers such as band neutrophil morphology and toxic change helps separate these processes.

Common Interpretation Errors

Less experienced clinicians frequently overinterpret a single leukogram. A stress leukogram in a fractious cat or an anxious dog does not exclude concurrent inflammation, and a normal leukogram does not exclude infection. The corrective action is to interpret the leukogram as one component of a diagnostic plan that includes physical examination findings, other clinicopathologic data, and imaging.

A second common error is assigning diagnostic weight to eosinopenia or monocytosis without corroborating evidence. Eosinopenia accompanies endogenous or exogenous corticosteroid excess but has poor specificity. Monocytosis may reflect chronic inflammation, tissue necrosis, or physiologic stress, and its presence alone rarely changes management.

A third error involves the neutrophilic left shift in cats. Feline band neutrophils are smaller and less segmented than canine bands, and automated analyzers may misclassify them. Manual blood smear review remains the standard for confirming a left shift in either species. The American Society for Veterinary Clinical Pathology quality assurance guidelines address smear review protocols and the validation of automated differential counts.

A fourth error is failing to account for breed and age variation. Greyhounds and other sighthounds have higher resting red cell parameters and lower neutrophil counts than other breeds. Young animals mount more pronounced left shifts, while geriatric patients may show an inadequate response to severe infection.

Limitations of Current Evidence

The leukogram literature relies heavily on experimental models of endotoxemia and sterile inflammation, which do not fully replicate spontaneous disease. The magnitude and timing of the neutrophilic response vary with the causative organizm, the tissue involved, and the host immune status. Expert opinion still differs on the clinical significance of a mild left shift without toxic change in an otherwise stable patient. Some clinicians treat this as an early indicator of bacterial infection, while others recommend repeat evaluation before committing to antimicrobial therapy.

The stress leukogram literature in cats is similarly constrained. Feline cortisol responses to hospitalization and handling are well documented, but the translation of those responses to specific leukogram changes is less consistent than in dogs. Psychogenic stress in hospitalized dogs has been reviewed with attention to the hypothalamic-pituitary-adrenal axis and its immunologic consequences, yet comparable feline data remain sparse.

The anesthetic-surgical stress response in dogs and cats includes measurable hematologic changes, but the duration of those changes and their overlap with postoperative inflammation are not fully characterized. Clinicians should therefore interpret leukograms obtained within 48 hours of surgery with caution.

Referral and Escalation Criteria

Referral or specialist consultation is warranted when leukopenia persists beyond 48 hours despite supportive care, when toxic change accompanies a degenerative left shift, or when the leukogram suggests a hematologic malignancy such as lymphoblastic leukemia. A veterinary clinical pathologist should review the blood smear when automated counts and manual findings disagree, when atypical cells are present, or when the leukogram is needed to guide chemotherapy decisions.

Laboratory involvement is also appropriate when reference interval questions arise. The ASVCP guidelines provide a framework for verifying that laboratory reference intervals match the patient population being tested.

Regulatory reporting obligations vary by jurisdiction and by the suspected disease. Certain infectious causes of leukopenia, including vector-borne and zoonotic agents, may be reportable to state or national authorities. The World Organization for Animal Health terrestrial animal health standards list notifiable diseases that can present with hematologic abnormalities, and the AVMA practice resources direct clinicians to current reporting requirements. When cytauxzoonosis is suspected in an endemic region, prompt communication with a veterinary diagnostic laboratory is advised because diagnosis of this emerging disease may require specialized testing beyond routine hematology.

Troubleshooting Table

Frequently Asked Questions

How Do I Distinguish a Stress Leukogram from Early Inflammation When Cortisol and Other Stress Markers Are Not Measured?

When endocrine testing is unavailable, pattern recognition and serial sampling are your primary tools. A stress leukogram typically shows mature neutrophilia, lymphopenia, and eosinopenia with a normal or mildly increased monocyte count. Inflammatory leukograms more often feature a left shift, toxic change, or monocytosis out of proportion to the neutrophilia. Serial complete blood counts are decisive: stress patterns fluctuate with hospitalization and handling, while inflammatory patterns progress or persist. The neuroendocrine response to hospitalization and pain can amplify stress effects, as described in psychogenic stress reviews in hospitalized dogs, so interpret a single sample cautiously. If the patient is painful, febrile, or has a surgical or traumatic history, treat the leukogram as inflammatory until proven otherwise.

What Can I Do When In-House Hematology Produces Unreliable Differential Counts?

If the in-house analyzer flags abnormal cells, fails to differentiate, or reports implausible values, request a manual blood smear review and a reference laboratory complete blood count. The ASVCP quality assurance guidelines address instrument limitations and the need for method validation, and they support the practice of confirming abnormal results with a validated method. In the interim, use the analyzer's total white blood cell count with a carefully performed manual differential from a fresh smear. Do not base treatment decisions on a single suspect neutrophil or lymphocyte count. If the sample is clotted or delayed, redraw before committing to a diagnostic or therapeutic plan.

How Should I Interpret a Leukogram in a Cat with Suspected Cytauxzoonosis?

Cytauxzoonosis typically produces a severe inflammatory leukogram with marked neutropenia or neutrophilia, left shift, and toxic change, but these findings are nonspecific. The diagnosis rests on identifying Cytauxzoon felis organizms in erythrocytes or macrophages, and clinical signs often precede detectable parasitemia. As reviewed in cytauxzoonosis diagnostic guidance, the geographic range of the vector tick is expanding, so include this disease in differentials for febrile, icteric, or depressed cats in endemic and newly recognized regions. A leukogram cannot confirm or exclude the infection. Pair hematologic findings with blood smear examination, and pursue polymerase chain reaction testing when available.

What Is the Most Cost-Effective Way to Monitor a Patient with a Persistent Neutrophilia?

Serial total white blood cell counts with manual differentials are usually sufficient for trend monitoring once the initial diagnostic workup is complete. Reserve repeat biochemistry panels and imaging for clinical deterioration or for specific differentials that require reassessment. Document the trend in the medical record with the date, sample quality, and any concurrent treatments such as glucocorticoids or antimicrobials. The AVMA practice resources emphasize clear medical record keeping as a component of professional practice. If the neutrophilia stabilizes and the patient is clinically improving, weekly or biweekly counts may be adequate. Escalate monitoring frequency if a left shift, toxic change, or new cytopenia appears.

How Do I Explain a Stress Leukogram to a Client Who Is Worried About Cancer?

Use concrete language and avoid speculation. State that the blood test shows changes consistent with stress or inflammation, not a specific disease. Explain that stress hormones released during hospitalization or pain can alter white blood cell numbers, and that this pattern is common and often reversible. Reference the documented effects of stress on immune function in hospitalized animals, as summarized in stress physiology and immune consequences reviews. Reassure the client that a single abnormal leukogram is not a cancer diagnosis, and outline the next diagnostic step, whether that is a recheck in 24 to 48 hours, a biochemistry panel, or imaging. Offer the plan in writing if the client appears anxious.

Should I Repeat a Leukogram Before Discharge in a Patient Whose Initial Sample Showed a Stress Pattern?

Repeat the sample only if the result will change the discharge plan. If the patient is clinically improving and the initial leukogram was consistent with stress, a repeat count that shows resolution supports the diagnosis and may reduce unnecessary follow-up. If the patient remains febrile, lethargic, or anorexic, repeat the complete blood count and add a biochemistry panel. The anesthetic-surgical stress response can persist for days after procedures, as described in reviews of surgical stress in dogs and cats, so interpret post-operative leukograms with that timeline in mind. Document the reason for repeating or not repeating the test in the discharge summary.

Related Clinical & Scientific Guides

• Peripheral Blood Smear Evaluation: A Step-by-Step Guide
• Reticulocyte Counts in Veterinary Medicine: Clinical Utility and Interpretation
• Cerebrospinal Fluid Analysis in Veterinary Neurology: Collection and Interpretation

References and Further Reading

• Psychogenic Stress in Hospitalized Dogs: Cross Species Comparisons, Implications for Health Care, and the Challenges of Evaluation.. 2014.
• Cytauxzoonosis: Diagnosis and treatment of an emerging disease.. 2015.
• Neurobiology of anesthetic-surgical stress and induced behavioral changes in dogs and cats: A review.. 2021.
• American Society for Veterinary Clinical Pathology Guidelines. American Society for Veterinary Clinical Pathology.
• MSD Veterinary Manual, Professional Edition. MSD Veterinary Manual.
• American Veterinary Medical Association Practice Resources. American Veterinary Medical Association.
• WOAH Terrestrial Animal Health Code. WOAH.

Related Articles

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• Monitoring Effusion Recurrence and Management in Dogs and Cats
• Monitoring Blood Glucose Curves in Diabetic Dogs and Cats
• Monitoring Hepatic Enzyme Trends in Dogs and Cats: Clinical Significance

This article is educational professional reference material for veterinary audiences. It is not a substitute for veterinary diagnosis, individual clinical judgment, current product labeling, or applicable regulatory requirements.