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Background and objective  Anti‐pyretic treatment is recommended in the management of influenza infection. In animal models anti‐pyretic treatment increases mortality from influenza. We investigated the effects of paracetamol on viral and clinical outcomes in adults with influenza infection.    Methods  This is a randomized, double‐blind, placebo‐controlled trial of adults aged 18–65 years with influenza‐like illness and positive influenza rapid antigen test. Treatments were 1 g paracetamol four times a day, or matching placebo, for 5 days. Pernasal swabs were taken for influenza quantitative  RT‐PCR  at  B aseline and  D ays 1, 2 and 5. Temperature and symptom scores were recorded for 5–14 days or time of resolution respectively. The primary outcome variable was area under the curve ( AUC ) for quantitative  PCR  log 10  viral load from  B aseline to  D ay 5.Results  A total of 80 participants were randomized: no one was lost to follow up, and one withdrew after 4 days. There were 22 and 24 participants who were influenza  PCR ‐positive in placebo and in paracetamol groups respectively. Mean ( SD )  AUC PCR  log 10  viral load was 4.40 (0.91) in placebo and 4.64 (0.88) in paracetamol; difference was −0.24, 95%  CI : −0.78 to 0.29,  P  = 0.36. In all participants there were no differences in symptom scores, temperature, time to resolution of illness and health status, with no interaction between randomized treatment and whether influenza was detected by  PCR .    Conclusion  Regular paracetamol had no effect on viral shedding, temperature or clinical symptoms in patients with  PCR ‐confirmed influenza. There remains an insufficient evidence base for paracetamol use in influenza infection.  Clinical trial registration:   ACTRN 12611000497909 at the  A ustralian  N ew  Z ealand  C linical  T rials  R egistry.

Randomized controlled trial of the effect of regular paracetamol on influenza infection