Background: Empathy is an essential competence in the medical field. There are no validated patient-rated empathy measures in Spanish (Spain). The Consultation and Relational Empathy (CARE) measure is a widely used patient-rated measure of physician empathy. Objective: To analyse the reliability and validity of the Spanish (Spain) version of the CARE measure in primary care. Methods: After translation, back translation and pilot testing, a convenient sample of 369 patients recruited through 21 primary care physicians in five primary care centres in Pamplona (Navarre, Spain) completed the Spanish (Spain) CARE (Sp-CARE) measure. The number of 'does not apply' or blank responses was calculated to assess acceptability. We analysed internal reliability by means of Cronbach's alpha and ordinal alpha and homogeneity with corrected item-total correlations.The construct validity was examined by confirmatory factor analysis (CFA) and concurrent validity by Spearman's correlation. Results: We observed high acceptability; only 37 (1%) responses were marked 'does not apply' and only 3 (0.08%) were left blank. Cronbach's alpha and ordinal alpha for the Sp-CARE measure were 0.953 and 0.970, respectively, and all corrected item-total correlations exceeded the accepted cut of 0.30, demonstrating high internal reliability and homogeneity. CFA corroborated the one-factor structure proposed in the original version. The Sp-CARE measure total score was significantly correlated with overall patient satisfaction (Spearman's rho 0.45, P < 0.001). Conclusion: The results support the reliability and validity of the Sp-CARE measure as a patient-rated empathy measure in the primary care setting.