What is the recommended dose of epinephrine IM for anaphylaxis, along with evidence to support this dosing?

Comment by InpharmD Researcher

Intramuscular epinephrine is the first line treatment for anaphylaxis, with guidelines consistently recommending a dose of 0.01 mg/kg using the 1 mg/mL (1:1000) concentration, administered into the mid anterolateral thigh. Maximum single doses are 0.3 mg in prepubertal children and 0.5 mg in adolescents and adults, with repeat dosing every 5 to 15 minutes for persistent or recurrent symptoms. This dosing strategy is supported by multiple international guidelines, including those from the American Heart Association and the American Academy of Pediatrics, based on longstanding clinical use, pharmacokinetic data demonstrating rapid peak concentrations after IM administration, and favorable safety experience. Evidence also supports thigh administration due to higher and faster peak plasma concentrations compared with other injection sites. One study further suggests that an initial 0.5 mg IM dose in adults may reduce the need for additional epinephrine or escalation of care compared with 0.3 mg, without clear differences in major safety outcomes, reinforcing current guideline based dosing recommendations (Table 3).

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Background

A 2020 Chinese guideline on the emergency management of anaphylactic reactions aimed to provide evidence-based recommendations for the emergency management of anaphylaxis. The recommended dose of intramuscular (IM) epinephrine is 0.01 mg/kg, with a maximum dose of 0.5 mg for patients aged 14 years and older, and a maximum of 0.3 mg for patients under 14 years. The concentration used should be 1 mg/mL (1:1000), consistent with commercial preparations. If there is no response, repeat dosing is suggested every 5 to 15 minutes, as strongly recommended by clinical guidelines. A systematic review did not find any randomized controlled trials (RCTs) evaluating different doses of epinephrine, but four clinical guidelines support the recommended dosage and concentration. Additionally, six guidelines advise on the 5 to 15-minute intervals for repeated doses. This dosing protocol has been longstanding, supported by safety data, with the Tmax for IM epinephrine reported as 8 ± 2 minutes, which aligns with the recommended re-dosing interval. It is crucial to closely observe the patient's response, establish venous access, and be ready to administer a second dose if necessary. [1]

The panel also stated that IM epinephrine should be administered in the mid-anterolateral thigh, according to a strong recommendation. This preference is based on evidence suggesting that administering epinephrine at this site results in a higher maximum plasma concentration (Cmax) compared to injections in the upper arm, as demonstrated in a randomized cross-over trial. Although the trial presented low-quality evidence and indicated uncertain evidence of a potential for mild transient adverse effects when injecting into the thigh, no other comparative studies were found to challenge these findings. Clinical guidelines consistently recommend the mid-anterolateral thigh as the optimal injection site, as it facilitates better drug delivery without serious safety concerns. This recommendation persists despite some healthcare providers being more familiar with using the upper arm for IM injections. [1]

The 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care emphasize prompt IM administration as lifesaving, with the anterolateral thigh preferred due to faster and higher peak plasma concentrations. Standard dosing endorsed across guidelines includes 0.3 to 0.5 mg IM for adults and 0.01 mg/kg for pediatric patients until the adult dose is reached, with repeat doses every 5 to 15 minutes as needed and no cumulative maximum dose. Pediatric dosing recommendations are supported by organizations including the American Academy of Pediatrics (AAP) and the American Academy of Allergy, Asthma & Immunology, which recognize fixed autoinjector doses of 0.15 mg for smaller children and support transition to 0.3 mg at lower weight thresholds to reduce underdosing. [2], [3], [4]

A 2017 clinical report from the AAP discussed the use of epinephrine for first-aid management of anaphylaxis. Upon recognition of an anaphylactic event, prompt administration of epinephrine by the IM route can be life-saving. In healthcare settings, traditionally an epinephrine dose of 0.01 mg/kg is injected IM to a maximum of 0.3 mg in a prepubertal child and up to 0.5 mg in a teenager. Epinephrine autoinjectors can also be administered at a dose of 0.15 mg in a young child and 0.3 mg in a child or teenager. In regards to the safety of epinephrine, IM injection of epinephrine was found to achieve peak concentrations faster than that given by subcutaneous (SC) injection (Table 1). Additionally, IM epinephrine generally poses a low risk of serious adverse effects. [5]

Consistent with guideline recommendations, available review articles likewise support prompt IM epinephrine at the earliest signs of anaphylaxis, administered into the mid anterolateral thigh with immediate transport to an emergency department. Recommended dosing is 0.01 mg/kg using the 1 mg/mL concentration, up to a maximum of 0.5 mg in adults and 0.3 mg in children, with some sources specifying 0.5 mg IM for adults and adolescents and 0.01 mg/kg in children weighing 30 kg or less to a maximum of 0.3 mg in prepubertal children and 0.5 mg in adolescents. Repeat dosing every 5 to 15 minutes is advised for persistent, refractory, or recurrent symptoms, although most patients require only one or two doses. There are no contraindications to epinephrine in the treatment of anaphylaxis, including in patients with cardiovascular disease, hypertension, or those receiving beta blockers, and delays in administration have been associated with more severe reactions and increased mortality. Autoinjectors provide fixed doses of 0.3 mg for adults and children or adolescents weighing more than 30 kg and 0.15 mg for children weighing 15 to 30 kg, with brief pressure against the skin after activation to ensure full delivery. [6], [7]

References: [1] Li X, Ma Q, Yin J, et al. A Clinical Practice Guideline for the Emergency Management of Anaphylaxis (2020). Front Pharmacol. 2022;13:845689. Published 2022 Mar 28. doi:10.3389/fphar.2022.845689
[2] Panchal AR, Bartos JA, Cabañas JG, et al. Part 3: Adult Basic and Advanced Life Support: 2020 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2020;142(16_suppl_2):S366-S468. doi:10.1161/CIR.0000000000000916
[3] Gaudio FG, Johnson DE, DiLorenzo K, et al. Wilderness Medical Society Clinical Practice Guidelines on Anaphylaxis. Wilderness Environ Med. 2022;33(1):75-91. doi:10.1016/j.wem.2021.11.009
[4] Golden DBK, Wang J, Waserman S, et al. Anaphylaxis: A 2023 practice parameter update. Ann Allergy Asthma Immunol. 2024;132(2):124-176. doi:10.1016/j.anai.2023.09.015
[5] Sicherer SH, Simons FER. Epinephrine for First-aid Management of Anaphylaxis. Pediatrics. 2017;139(3):e20164006. doi:10.1542/peds.2016-4006
[6] Casale TB, Burks AW. Clinical practice. Hymenoptera-sting hypersensitivity. N Engl J Med. 2014;370(15):1432-1439. doi:10.1056/NEJMcp1302681
[7] Morriello F, Chapman M. Epinephrine in anaphylaxis. CMAJ. 2023;195(19):E683. doi:10.1503/cmaj.221319
Relevant Prescribing Information

Dosage and Administration [8]
Patients greater than or equal to 30 kg (66 lbs): Epinephrine injection, 0.3 mg
Patients 15 to 30 kg (33 lbs to 66 lbs): Epinephrine injection, 0.15 mg

References: [8] Epinephrine injection. Prescribing information. ​​Teva Pharmaceuticals USA, Inc.; 2021.
Literature Review

A search of the published medical literature revealed 3 studies investigating the researchable question:

What is the recommended dose of epinephrine IM for anaphylaxis, along with evidence to support this dosing?

Level of evidence

A - Multiple high-quality studies with consistent results  Read more→



Please see Tables 1-3 for your response.


 

Epinephrine absorption in children with a history of anaphylaxis

Design

Prospective, randomized, blinded, parallel-group study

N= 17

Objective

To compare the pharmacokinetics of epinephrine administered subcutaneously (SC) and intramuscularly (IM) in children with anaphylactic allergies

Study Groups

SC (n= 9)

IM (n= 8)

Inclusion Criteria

Age 4 to 12 years, weight 15 to 40 kg, history of severe allergies and systemic anaphylaxis, carried injectable epinephrine at all times

Exclusion Criteria

Did not assent to epinephrine injection and venipuncture, recent acute illness, required any oral or injected medication during the month before the study or during the study, could not discontinue inhaled β2-adrenergic agents for 24 hours before the study or during the study

Methods

Patients were randomized to receive SC (0.01 mL/kg; maximum 0.3 mL [0.3 mg]) or IM (0.3 mg) epinephrine injections. Before injection and at 5, 10, 15, 20, 30, 40, 60, 90, 120, and 180 minutes afterward, a 3.5 ml blood sample for plasma epinephrine measurement was obtained from the indwelling venous catheter. Before injection and at 30, 60, 120, and 180 minutes afterward, systolic and diastolic blood pressure and heart rate were monitored, and a rhythm strip was obtained. Epinephrine concentrations were measured with a high-performance liquid chromatography (HPLC) reverse-phase system with electrochemical detection.

Duration

Evaluation: 180 minutes after injection

Outcome Measures

Baseline plasma concentration (Cbaseline), maximum plasma concentration (Cmax), time at which maximum plasma concentration was achieved (tmax), terminal elimination half-life (t1/2), area under the plasma concentration versus time curve (AUC; t= 0 to 3 hours for subcutaneous; t= 0 to infinity for intramuscular), total body clearance (Cl), volume of distribution at steady state (Vdss)

Baseline Characteristics

 

SC (n= 9)

IM (n= 8)

 

Age, years

8 ± 1 8 ± 1  

Weight, kg

32 ± 3 27 ± 2  

Epinephrine dose, mg

0.27 ± 0.04 0.3  

Results

Endpoint

SC (n= 9)

IM (n= 8)

p-value

Pharmacokinetic parameters

Cbaseline, pg/mL

Cmax, pg/mL

tmax, min

t1/2, min

AUC, ng/mL/min

Cl, mL/min/kg

Vdss, L/kg



285 ± 32

1,802 ± 214

34 ± 14

-

67 ± 13

-

-



339 ± 115

2,136 ± 351

8 ± 2

43 ± 15

108 ± 18

147 ± 38

2.0 ± 1.5



-

-

< 0.05

-

-

-

-

Adverse Events

Common Adverse Events: An increase in heart rate and blood pressure was observed at the time of peak plasma concentrations in a few children, but most peak values were within the wide range of normal values. Differences in vital signs were not evaluated based on the epinephrine formulation administered. Overall, no correlations were found between changes in vital signs and epinephrine concentrations.

Serious Adverse Events: None

Percentage that Discontinued due to Adverse Events: N/A

Study Author Conclusions

In children, recommendations for subcutaneous epinephrine injection are based on anecdotal experience, and should be reevaluated in view of our finding of delayed epinephrine absorption when this route is used. This delay might have important clinical implications during an episode of systemic anaphylaxis. The intramuscular route of injection is preferable.

InpharmD Researcher Critique

This study did not evaluate the efficacy of epinephrine formulations in the treatment of anaphylaxis, and conclusions are solely based on the improved time to reach maximal concentrations with intramuscular epinephrine.



References:
[1] [1] Simons FE, Roberts JR, Gu X, Simons KJ. Epinephrine absorption in children with a history of anaphylaxis. J Allergy Clin Immunol. 1998;101(1 Pt 1):33-37. doi:10.1016/S0091-6749(98)70190-3

 

Epinephrine absorption in adults: Intramuscular versus subcutaneous injection

Design

Prospective, randomized, blinded, placebo-controlled, 6-way crossover study

N= 13

Objective

To provide information regarding the optimal route and site of epinephrine injection in adults, in whom it was hypothesized that intramuscular (IM) injection would be superior to subcutaneous (SC) injection

Study Groups

All subjects (n= 13)

Inclusion Criteria

Healthy allergic men, aged 18 to 35 years

Exclusion Criteria

History of cardiovascular, thyroid, or central nervous system disorder, smoking or use of any medications or recreational drugs

Methods

Participants were asked to come to the research center on 6 different mornings. The visits were scheduled at least one week apart and one injection was given at each visit. Each participant received 4 injections of epinephrine 0.3 mg (0.3 mL) and 2 injections of saline solution (0.9% NaCl, 0.3 mL) during the course of the study which was administered through the use of a variety of injection routes and sites. Epinephrine USP 1:1000, 0.3 mg (0.3 mL) was injected either IM into the vastus lateralis muscle (through the use of an EpiPen) or the deltoid muscle or SC in the deltoid region. Saline solution (0.3 mL) was injected IM into the deltoid muscle or SC in the deltoid region.  Plasma epinephrine concentrations were monitored before and for 180 minutes after each injection of epinephrine or saline solution.

Duration

Six different visits; scheduled at least 1 week apart; each visit lasted 3.5 to 4 hours. 

Outcome Measures

Mean maximum plasma epinephrine concentrations

Baseline Characteristics

 

All subjects (n= 13)    

Age, years

26 ± 2     

Weight, kg

85 ± 5

Body mass index, kg/m2

36.6 ± 4.6     

Male

100%     

Results

Injection route

EpiPen IM

Epinephrine IM

Epinephrine IM

Epinephrine SC

Saline IM

Saline SC

Injection site

Thigh Thigh Arm Arm Arm Arm

*Cmax, pg/mL

12,222** ± 3,829 9,722** ± 4,801 1,821 ± 426 2,877 ± 567 1,458† ± 444 1,495† ± 524

*The peak plasma epinephrine concentration (Cmax) was measured in each participant during each visit (from 5 to 180 minutes after injection, regardless of the time at which the peak concentration occurred). The mean peak concentration (Cmax ± SEM value) was then calculated after the injection of epinephrine or saline solution by each route and at each site.

**p < 0.01 from all arm values.

†Endogenous epinephrine.

Adverse Events

Mild transient adverse effects were reported after 21 of the 52 epinephrine injections and after 3 of the 26 saline injections. The most common adverse effects were pallor after 13 injections, tremors after 7 injections, and heart pounding after 7 injections. Headache occurred after 3 injections, shivers after 1 injection, and dizziness after 1 injection. Some men experienced several adverse effects concurrently.

Study Author Conclusions

The authors recommend the intramuscular injection of epinephrine into the thigh as the preferred route and site of injection of this life-saving medication in the initial treatment of anaphylaxis.

InpharmD Researcher Critique

It should be noted that due to ethical reasons this study was not performed during severe acute allergic reactions. The results are further limited by the small sample size and cross-over nature of the study. 



References:
[1] [1] Simons FE, Gu X, Simons KJ. Epinephrine absorption in adults: intramuscular versus subcutaneous injection. J Allergy Clin Immunol. 2001;108(5):871-873. doi:10.1067/mai.2001.119409

 

Retrospective comparison between 0.3 mg and 0.5 mg dosing of intramuscular epinephrine for anaphylaxis
Design

Retrospective cohort analysis

N= 338

Objective To investigate the incidence of escalating care after initial epinephrine dosing in management of anaphylaxis
Study Groups

0.3 mg group (n= 254)

0.5 mg group (n= 84)

Inclusion Criteria Patients who were at least 18 years of age and had received at least one dose of IM epinephrine for anaphylaxis, based on the World Allergy Organization definition or clinical suspicion by the treating physician
Exclusion Criteria Patients who received a dose of IM epinephrine from Emergency Medical Services, administered their own epinephrine autoinjector, or weighed less than 50 kg
Methods Retrospective chart review of patients receiving IM epinephrine 0.3 mg or 0.5 mg for anaphylaxis. 
Duration January 1, 2018 to November 17, 2024
Outcome Measures Incidence of escalating care after initial dose of IM epinephrine, resolution of symptoms, length of stay in the emergency department, safety outcomes (heart rate, systolic blood pressure, EKG changes, troponin levels)
Baseline Characteristics   IM epinephrine 0.3 mg (n = 254) IM epinephrine 0.5 mg (n = 84) p-value
Age, years 42 (28–56) 49.5 (33.8–61.0) 0.340
Male 93 (36.6%) 38 (45.2%) 0.160

Race

White (Non-Hispanic)

Black

Hispanic

Asian

Other

 

187 (73.6%)

41 (16.1%)

18 (7.1%)

2 (0.8%)

6 (2.4%)

 

70 (83.3%)

11 (13.1%)

3 (3.6%)

0 (0)

0 (0)

0.281 
Height, cm 167.6 (160.0–175.3) 167.6 (160.0–176.5) 0.729
Weight, kg 81.8 (70.5–95.2) 86.2 (69.2–100.1) 0.302
Anaphylaxis was reason for presentation 178 (70.1%) 69 (82.1%) 0.031

Initial Symptoms

Urticaria

Facial or mouth swelling

Shortness of breath

Wheezing

Hypotension and/or shock

Dizziness without syncope

Syncope

GI pain or diarrhea

Laryngeal edema

Cough

Nausea and/or vomiting

Tachycardia

 

196 (74.2%)

89 (35.0%)

143 (56.3%)

36 (14.2%)

34 (13.4%)

27 (10.6%)

2 (0.8%)

24 (9.4%)

37 (14.6%)

12 (4.7%)

61 (24.0%)

43 (16.9%)

 

67 (79.7%)

40 (47.6%)

49 (58.3%)

14 (16.6%)

8 (9.5%)

3 (3.5%)

2 (2.4%)

9 (10.7%)

12 (14.3%)

1 (1.2%)

15 (17.9%)

14 (16.7%)

 

0.620

0.040

0.744

0.577

0.352

0.149

1.000

0.735

0.949

0.198

0.241

0.956

At least one severe symptom  99 (40.0%) 30 (35.7%) 0.594

Receipt of other anaphylaxis medications

Steroids

Antihistamines

Albuterol

241 (95.3%)

227 (91.2%)

239 (96.0%)

50 (20.1%)

79 (94.0%)

77 (92.8%)

81 (97.6%)

13 (15.7%)

0.661

0.544

0.409

0.391

Results   IM epinephrine 0.3 mg (n = 254) IM epinephrine 0.5 mg (n = 84) p-value
Escalation of care  75 (29.5%) 6 (7.1%) <0.001
Additional IM epinephrine dose 71 (28.0%) 5 (6.0%) <0.001
Epinephrine infusion 20 (7.8%) 1 (1.2%) 0.034
Intubation 7 (2.8%) 0 (0.0) 0.199
Time from first IM epinephrine dose to first escalation of care, min 26 (9.5–78.5) 29 (16.5–39.3) 0.928
Resolution of symptoms after first epinephrine dose  184 (72.4%) 80 (95.2%) <0.001
Requirement of hospital admission 51/178 (28.7%) 10/69 (14.5%) 0.010
ED Length of Stay, hrs 5.0 (3.9–6.9) 4.1 (2.8–5.4) <0.001
Adverse Events No major difference between groups for peak increase in heart rate, systolic blood pressure > 200 mmHg, ischemic changes on EKG, atrial or ventricular arrhythmia, or elevated troponin. However, safety data was not documented in many patients, making findings difficult to interpret
Study Author Conclusions Significantly fewer patients receiving an initial 0.5 mg IM epinephrine dose required escalation of care compared to those who received 0.3 mg. Future prospective studies are needed to confirm the results of this study. 
Critique The study provides valuable insights into the dosing of IM epinephrine for anaphylaxis, showing a clear benefit of the 0.5 mg dose in reducing escalation of care. However, the retrospective design and missing safety data limit the ability to draw definitive conclusions about safety. The study's single-health system setting may also limit generalizability. Further prospective studies are needed to confirm these findings and assess safety outcomes more thoroughly. 
References:
[1] [1] Jackson CA, Dillon RC, Fleenor LM, Pauw EK, O'Keefe MM. Retrospective comparison between 0.3 mg and 0.5 mg dosing of intramuscular epinephrine for anaphylaxis. Am J Emerg Med. 2026;99:270-275. doi:10.1016/j.ajem.2025.10.020