U.S. Department of Health and Human Services 

Food and Drug Administration 

Center for Food Safety and Applied Nutrition 

CFSAN Adverse Event Reporting System 

Voluntary and Mandatory Reports on 5-Hour Energy, Monster Energy, and Rockstar 

Energy Drink 

January 1, 2004, through October 23, 2012 

Introduction 

FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting 

System (CAERS) collects reports about adverse health events and product complaints 

related to CFSAN-regulated products, including conventional foods, dietary supplements, 

and cosmetics. Based on a search of CAERS, this document summarizes the adverse 

events reported to FDA in connection with products under the labels 5-Hour Energy, 

Monster, and Rockstar between January 1, 2004 and October 23, 2012. These products 

are currently marketed as dietary supplements. 

CAERS includes voluntary reports for cosmetics and conventional foods, and both 

voluntary and mandatory reports for dietary supplements. Mandatory reports are those 

required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act. 

Specifically, dietary supplement manufacturers, packers, and distributors must notify 

FDA if they receive reports about serious adverse events in connection with the use of 

their products. This law defines a serious adverse event as an adverse health-related event 

that is associated with the use of a dietary supplement and that results in death, a lifethreatening experience, inpatient hospitalization, a persistent or significant disability or 

incapacity, a congenital anomaly or birth defect, or that requires, based on reasonable 

medical judgment, a medical or surgical intervention to prevent one of those outcomes. 

The requirement to report serious adverse events to FDA applies only to dietary 

supplements and not to beverages, other conventional foods, or cosmetics. 

Medical officers with the agency's Dietary Supplement Program staff review all serious 

adverse events reported to FDA about dietary supplements as part of the normal process 

of assessment and categorization. In addition to these mandatory reports, the CAERS 

system also contains adverse events (both serious and non-serious) that are voluntarily 

reported to FDA by consumers and health care providers. 

FDA encourages consumers and health care providers to report adverse events they 

believe may be related to FDA-regulated products to FDA's MedWatch Adverse Event 

Reporting Program (http://www.fda.gov/Safety/MedWatch/default.htm). FDA advises 

consumers to talk with their health care providers before using any product marketed as 

an “energy shot” or “energy drink.” 
Things You Should Know About Adverse Event Report Data

 

Individual adverse event reports about a particular product and the total number of 

adverse event reports for that product in CAERS only reflect information AS 

REPORTED and do not represent any conclusion by FDA about whether the product 

actually caused the adverse events. Because CAERS is constantly updated with new 

information, the number of reports for a given product and the content of individual 

reports may change over time. 

Even with mandatory reporting of serious adverse events for dietary supplements, 

generally only a small fraction of adverse events associated with any product is reported. 

On the other hand, there may be duplicate reports in CAERS for the same adverse event 

because multiple people (such as an injured consumer and a health care provider who 

treated him or her) may have submitted reports. 

There are important limitations to making inferences based on data from adverse event 

reports, such as those in CAERS. 

 Reports to FDA do not necessarily include all relevant data, such as whether an 

individual also suffered from other medical conditions (such as cardiac disease) or 

took other supplements or medication at the same time. 

 Reports may not include accurate or complete contact information for FDA to 

seek further information about the event, or complainants may choose not to 

participate in the follow-up investigation. 

When important information is missing from a report, it is difficult for FDA to fully 

evaluate whether the product caused the adverse event or simply coincided with it. The 

fact that an adverse event happened after a person took a dietary supplement does not 

necessarily mean that the dietary supplement caused the adverse event. 
Report # Received 

Date

Brand/ Product 

Name

Symptoms Outcomes

79019 6/22/05 5 HOUR ENERGY 

CHASER

FEELING ABNORMAL, FLUSHING NON-SERIOUS INJURIES/ ILLNESS

5/11/0710/19/07

100018 11/14/07 5 HOUR ENERGY 

ENERGY DRINK - BERRY FLAVOR

HYPERVENTILATION, DYSPHONIA, DISORIENTATION, TREMOR, DYSPNOEA, CONVULSION, POISONING

HOSPITALIZATION, LIFE THREATENINGER, VISITED A HEALTH CARE PROVIDEINJURIES/ ILLNESS

CAERS Adverse Events Reports Allegedly Related to 5 Hour Energy

Search Terms: 5 Hour, Five Hour, 5Hour, FiveHour

The Center for Food Safety Adverse Event Reporting System (CAERS) is a post-market surveillance system that collects reports about eventhat are allegedly related to CFSAN regulated products. In some reports, information in the reports cannot be verified for accuracy. Furthermreports, individuals may have used other products, and many products contain multiple ingredients which further complicates the evaluation event reports. There is no certainty that a reported adverse event can be attributed to a particular product or ingredient. The number of adverse event reporreceived by FDA and the adverse event report itself about a particular product only reflects information AS REPORTED and does not repr

conclusion by FDA regarding a causal relationship or association with the product or ingredient. Due to the continuous inclusion of new or information into the CAERS system, reports released from CAERS containing adverse event data may change over time.

FLUSHING, LETHARGY, DIZZINESS, ANXIETY, DYSPNOEA, BLOOD PRESSURE FLUCTUATION, HEART RATE ABNORMAL, DYSPNOEA, SHOCK, CHEST PAIN, SYNCOPE, VOMITING,DIARRHOEA, VISUAL DISTURBANCE, DEAFNESS, MOOD ALTERED, FATIGUE, PALPITATIONS, TACHYCARDIA, HEART RATE INCREASED, DEPRESSION, HEADACHE, ANAPHYLACTIC REACTION

LIFE THREATENING, VISITED AN ER, VHEALTH CARE PROVIDER, REQ. INTERPRVNT PERM. IMPRMNT.

Each report received by CAERS regarding an individual that experiences an adverse event is assigned a unique report number (Report #).  ^ Additional dates indicate receipt of additional materials on report.

97070^ LIVING ESSENTIALS 

5HOUR BERRY FLAVOR ENERGY DRINK

Page 1
Report # Received 

Date

Brand/ Product 

Name

Symptoms Outcomes

3/10/0812/17/09

102367 3/10/08 LIVING ESSENTIALS 

5- HOUR ENERGY BERRY FLAVORED VITAMIN SUPPLEMENT

VOMITING, HEART RATE INCREASED NON-SERIOUS INJURIES/ ILLNESS

103323 4/17/08 5 HOUR ENERGY 

SHOT

HAEMORRHAGE NON-SERIOUS INJURIES/ ILLNESS

105441 7/23/08 LIVING ESSENTIALS 

5HOUR ENERGY

BLOOD PRESSURE FLUCTUATION, LETHARGY, DIZZINESS NON-SERIOUS INJURIES/ ILLNESS

106752 9/29/08 INNOVATION 

VENTURES, LLC 5-HOUR ENERGY DRINK

NERVOUSNESS, NAUSEA, DIZZINESS, LOSS OF CONSCIOUSNESS, HALLUCINATION

NON-SERIOUS INJURIES/ ILLNESS

117103 8/5/09 5 HOUR ENERGY 

DRINK

ABNORMAL LOSS OF WEIGHT, SLEEP DISORDER, ANXIETY NON-SERIOUS INJURIES/ ILLNESS

12/17/0912/30/093/1/1012/17/098/3/10

121681 12/17/09 5 HOUR ENERGY ABORTION SPONTANEOUS OTHER SERIOUS (IMPORTANT MEDICA121680^ 5 HOUR ENERGY DEATH DEATH

VISITED A HEALTH CARE PROVIDER, D

102062^ LIVING ESSENTIALS 

5- HOUR ENERGY BERRY FLAVORED VITAMIN SUPPLEMENT

HEART RATE ABNORMAL, FAECAL INCONTINENCE, LOSS OF CONSCIOUSNESS, DIZZINESS, VOMITING, DISORIENTATION, AGGRESSION, LOSS OF CONSCIOUSNESS, LETHARGY, HEADACHE, TENDERNESS, DIZZINESS, VOMITING PROJECTILE, HEART RATE INCREASED, DRUG TOXICITY

LIFE THREATENING, HOSPITALIZATION

121679^ 5 HOUR ENERGY SNEEZING, FALL, VOMITING, CHEST PAIN, PULSE ABSENT, 

HEAD INJURY

Page 2
Report # Received 

Date

Brand/ Product 

Name

Symptoms Outcomes

121748 12/29/09 5 HOUR ENERGY DYSPNOEA, CHEST PAIN, SWELLING VISITED AN ER, HOSPITALIZATION124601 3/16/10 5 HOUR ENERGY 

BERRY FLAVOR

HYPERSENSITIVITY VISITED AN ER, OTHER SERIOUS (IMP

MEDICAL EVENTS)

124602 3/16/10 5 HOUR ENERGY 

BERRY

MALAISE, HEART RATE INCREASED, HEAT ILLNESS VISITED AN ER, OTHER SERIOUS (IMP

MEDICAL EVENTS)

124603 3/16/10 5 HOUR ENERGY MYOCARDIAL INFARCTION VISITED AN ER, VISITED A HEALTH CA124605 3/16/10 5 HOUR ENERGY HOT FLUSH, HEART RATE INCREASED, ANXIETY, VISUAL 

IMPAIRMENT

OTHER SERIOUS (IMPORTANT MEDICA

124621 3/22/10 5 HOUR ENERGY HYPERHIDROSIS, HEART RATE INCREASED, ANXIETY, 

DIZZINESS, FEAR

VISITED AN ER, NON-SERIOUS INJURI

4/21/109/29/10

126785 5/19/10 5 HOUR ENERGY FEAR, MALAISE LIFE THREATENING

5/19/103/16/11

126994 5/14/10 5 HOUR ENERGY PALLOR, CHEST PAIN LIFE THREATENING, VISITED AN ER, O

(IMPORTANT MEDICAL EVENTS)

126995 5/14/10 5 HOUR ENERGY CARDIAC ARREST LIFE THREATENING126786^ 5 HOUR ENERGY CONVULSION OTHER SERIOUS (IMPORTANT MEDICA125698^ 5 HOUR ENERGY ARRHYTHMIA, SUPRAVENTRICULAR TACHYCARDIA, VISITED A HEALTH CARE PROVIDER

PALLOR, ANGINA PECTORIS

Page 3
Report # Received 

Date

Brand/ Product 

Name

Symptoms Outcomes

126996 5/14/10 5 HOUR ENERGY CONVULSION VISITED AN ER, OTHER SERIOUS (IMP

MEDICAL EVENTS)

128525 7/28/10 5 HOUR ENERGY DISORIENTATION, DIZZINESS, HEADACHE, 

CEREBROVASCULAR ACCIDENT, VISUAL ACUITY REDUCED

DISABILITY, OTHER SERIOUS (IMPORTEVENTS), HOSPITALIZATION

7/26/103/16/11

129061 8/13/10 5 HOUR ENERGY 5

HOUR ENERGY

VENTRICULAR ARRHYTHMIA, LOSS OF CONSCIOUSNESS, PNEUMONIA, CONVULSION, ACUTE RESPIRATORY FAILURE, ANOXIC ENCEPHALOPATHY

HOSPITALIZATION, DEATH

129370 8/20/10 5 HOUR ENERGY PALPITATIONS, HYPERTENSION HOSPITALIZATION129372 8/26/10 5 HOUR ENERGY DEATH DEATH131692 10/28/10 5 HOUR ENERGY SOMNOLENCE DEATH

10/28/10 5 HOUR ENERGY 

LEMON LIME

10/28/10 5 HOUR ENERGY 

EXTRA STRENGTH

10/2/10 5 HOUR ENERGY - 

GRAPE

10/2/10 5 HOUR ENERGY - 

BERRY FLAVOR

131693^ DEHYDRATION, PARALYSIS, FEELING JITTERY, TREMOR, 

MUSCLE CONTRACTIONS INVOLUNTARY, BLOOD POTASSIUM DECREASED, BLOOD CAFFEINE INCREASED

VISITED AN ER, LIFE THREATENING

131933^ CONVULSION, BITE OTHER SERIOUS (IMPORTANT MEDICA128651^ 5 HOUR ENERGY CONVULSION, SOMNOLENCE HOSPITALIZATION

Page 4
Report # Received 

Date

Brand/ Product 

Name

Symptoms Outcomes

132295 11/12/10 5-HOUR ENERGY 

POMEGRANA TE

DYSPHAGIA, JOINT DISLOCATION, PAIN, SWELLING, BRUXISM, JAW DISORDER

HOSPITALIZATION

132296 11/12/10 5-HOUR ENERGY 

BERRY

CONVULSION OTHER SERIOUS (IMPORTANT MEDICA

VISITEDAN ER, VISITED A HEALTH CARE PROV

132297 11/12/10 5 HOUR ENERGY CONVULSION OTHER SERIOUS (IMPORTANT MEDICA133099 12/2/10 5-HOUR ENERGY RENAL FAILURE OTHER SERIOUS (IMPORTANT MEDICA133162 11/18/10 5 HOUR ENERGY 

DIETARY SUPPLEMENT ENERGY DRINK

HEART RATE ABNORMAL, LOSS OF CONSCIOUSNESS, DIZZINESS

VISITED A HEALTH CARE PROVIDER

134732 1/24/11 5-HOUR ENERGY 

BERRY

AURA, LOSS OF CONSCIOUSNESS, CONVULSION VISITED AN ER, OTHER SERIOUS (IMP

MEDICAL EVENTS)

134733 1/24/11 5-HOUR ENERGY 

BERRY

CARDIAC ARREST, CEREBROVASCULAR ACCIDENT, DIZZINESS, FEELING JITTERY, RESPIRATORY ARREST

DISABILITY, OTHER SERIOUS (IMPORTEVENTS), LIFE THREATENING, HOSPIT

134734 1/24/11 5-HOUR ENERGY 

POMEGRANA TE

CONVULSION, PAIN, TREMOR, MUSCLE TWITCHING HOSPITALIZATION, VISITED AN ER, OT

(IMPORTANT MEDICAL EVENTS)

136165 2/25/11 5 HOUR ENERGY ANAPHYLACTIC SHOCK, DYSPNOEA, CHEST PAIN LIFE THREATENING, VISITED AN ER, O

(IMPORTANT MEDICAL EVENTS)

136166 2/25/11 5 HOUR ENERGY HYPOAESTHESIA, SUICIDAL IDEATION, PAIN, ACTIVITIES 

OF DAILY LIVING IMPAIRED

OTHER SERIOUS (IMPORTANT MEDICAHOSPITALIZATION

3/8/116/27/11

137118 3/24/11 5 HOUR ENERGY MYOCARDIAL INFARCTION, DEATH DEATH

VISITED A HEALTH CARE PROVIDER, HOSPITALIZATION

136625^ 5 HOUR ENERGY 

DRINK

HYPOAESTHESIA, BLOOD CREATINE PHOSPHOKINASE MB INCREASED

Page 5
Report # Received 

Date

Brand/ Product 

Name

Symptoms Outcomes

137273 3/24/11 5 HOUR ENERGY ANAPHYLACTIC SHOCK, URTICARIA, DYSPNOEA, 

LETHARGY, HYPERSOMNIA, ASTHENIA

LIFE THREATENING, VISITED AN ER, VHEALTH CARE PROVIDER, OTHER SER(IMPORTANT MEDICAL EVENTS)

138211 4/21/11 5 HOUR ENERGY 

EXTRA STRENGTH

RENAL IMPAIRMENT, FOETAL DISTRESS SYNDROME LIFE THREATENING, CONGENITAL ANO

139012 5/13/11 5 HOUR ENERGY DEATH DEATH139013 5/13/11 5 HOUR ENERGY DEATH DEATH139014 5/13/11 5 HOUR ENERGY 

EXTRA STRENGTH

ACUTE MYOCARDIAL INFARCTION, DIZZINESS, LOSS OF CONSCIOUSNESS, CEREBROVASCULAR ACCIDENT

HOSPITALIZATION, VISITED AN ER, LIFTHREATENING

139015 5/13/11 5 HOUR ENERGY HYPOTENSION OTHER SERIOUS (IMPORTANT MEDICA

HOSPITALIZATION

139016 5/13/11 5-HOUR ENERGY/ 

POMEGRANA TE

PAIN, HYPERHIDROSIS, CHEST DISCOMFORT, HEART RATE DECREASED

HOSPITALIZATION, VISITED AN ER, OT(IMPORTANT MEDICAL EVENTS)

139658 5/27/11 5 HOUR ENERGY 

ORANGE

PAIN, GENERALISED ERYTHEMA, HYPERTENSION, FEELING HOT, SWELLING FACE, HYPERSENSITIVITY, DYSPNOEA, URTICARIA, PALPITATIONS, PRURITUS, PO2 DECREASED, BREATH SOUNDS ABSENT

VISITED AN ER, LIFE THREATENING

140966 6/26/11 5 HOUR ENERGY COMA, CEREBROVASCULAR ACCIDENT, HYPOAESTHESIA, 

VISUAL IMPAIRMENT

HOSPITALIZATION, DISABILITY

140968 6/27/11 5 HOUR ENERGY VOMITING, HAEMATEMESIS, OESOPHAGEAL INJURY, 

INJURY

OTHER SERIOUS (IMPORTANT MEDICAHOSPITALIZATION

142050 8/1/11 5 HOUR ENERGY LETHARGY, ABDOMINAL PAIN, HEART RATE ABNORMAL NON-SERIOUS INJURIES/ ILLNESS142160 7/25/11 5 HOUR ENERGY DEATH DEATH

Page 6
Report # Received 

Date

Brand/ Product 

Name

Symptoms Outcomes

142161 7/25/11 5 HOUR ENERGY ABDOMINAL PAIN UPPER, NAUSEA, PAIN, BODY 

TEMPERATURE INCREASED, VOMITING, JAUNDICE, HEPATITIS, AMMONIA INCREASED, ALANINE AMINOTRANSFERASE INCREASED, BLOOD BILIRUBIN INCREASED, ASPARTATE AMINOTRANSFERASE INCREASED, BLOOD BILIRUBIN INCREASED, GAMMAGLUTAMYLTRANSFERASE INCREASED

VISITED AN ER, HOSPITALIZATION

142457 8/12/11 5 HOUR ENERGY COLD SWEAT, DIZZINESS, BLOOD PRESSURE 

DECREASED, LOSS OF CONSCIOUSNESS, CONVULSION, MYOCARDIAL INFARCTION, DYSPNOEA

HOSPITALIZATION, OTHER SERIOUS (MEDICAL EVENTS), LIFE THREATENIN

142772 6/13/11 LIVING ESSENTIALS/ 

BERRY FLAVORED 5-

HOUR ENERGY DRINK

VOMITING, BURNING SENSATION HOSPITALIZATION, VISITED A HEALTH 

PROVIDER, VISITED AN ER

143074 9/1/11 5 HOUR ENERGY CEREBROVASCULAR ACCIDENT, CEREBRAL 

HAEMORRHAGE

LIFE THREATENING, HOSPITALIZATION

143643 9/15/11 5 HOUR ENERGY 

LEMON LIME

HYPERSENSITIVITY LIFE THREATENING

143644 9/15/11 5 HOUR ENERGY 

POMEGRANA TE

HYPERSENSITIVITY VISITED AN ER, LIFE THREATENING

143645 9/15/11 5-HOUR ENERGY ACQUIRED IMMUNODEFICIENCY SYNDROME OTHER SERIOUS (IMPORTANT MEDICA144858 10/24/11 5 HOUR ENERGY MYOCARDIAL INFARCTION DEATH146464 11/22/11 LIVING ESSENTIALS 

5HOUR ENERGY POMEGRANA TE ENERGY SHOT

ABDOMINAL PAIN, ABDOMINAL PAIN UPPER NON-SERIOUS INJURIES/ ILLNESS

147296 12/30/11 5 HOUR ENERGY HOSPITALISATION HOSPITALIZATION

Page 7
Report # Received 

Date

Brand/ Product 

Name

Symptoms Outcomes

147297 12/30/11 5-HOUR ENERGY DEATH DEATH148558 2/6/12 5 HOUR ENERGY MYOCARDIAL INFARCTION OTHER SERIOUS (IMPORTANT MEDICA

2/6/12 5 HOUR ENERGY 

ORANGE

2/6/12 5 HOUR ENERGY 

POMEGRANA TE

148696 2/10/12 5 HOUR ENERGY CEREBROVASCULAR ACCIDENT, CARDIOMEGALY, HEART 

RATE INCREASED

OTHER SERIOUS (IMPORTANT MEDICA

148905 2/14/12 5 HOUR ENERGY VOMITING HOSPITALIZATION149591 3/2/12 5 HOUR ENERGY 

BERRY

CONVULSION OTHER SERIOUS (IMPORTANT MEDICA

149601 3/2/12 5 HOUR ENERGY 

BERRY

CONVULSION OTHER SERIOUS (IMPORTANT MEDICA

149603 3/2/12 5 HOUR ENERGY 

BERRY

CONVULSION OTHER SERIOUS (IMPORTANT MEDICA

3/9/124/18/12

150092 3/16/12 5-HOUR ENERGY RENAL DISORDER, JAUNDICE, TONGUE DISCOLOURATION OTHER SERIOUS (IMPORTANT MEDICA

HOSPITALIZATION

150093 3/16/12 5 HOUR ENERGY 

BERRY

ANAPHYLACTIC REACTION, DYSPNOEA, URTICARIA HOSPITALIZATION, VISITED AN ER, LIF

THREATENINGHOSPITALIZATION, VISITED AN ER, NOINJURIES/ ILLNESS

149857^ OTHER SERIOUS (IMPORTANT MEDICA

HOSPITALIZATION, VISITEDAN ER, VISITED A HEALTH CARE PROV

148559^ DYSPNOEA, TREMOR, HYPOAESTHESIA, CHEST PAIN

5 HOUR ENERGY BERRY

MYOCARDIAL INFARCTION, CHEST PAIN

Page 8
Report # Received 

Date

Brand/ Product 

Name

Symptoms Outcomes

150422 3/23/12 5 HOUR ENERGY MYOCARDIAL INFARCTION, CIRCULATORY COLLAPSE OTHER SERIOUS (IMPORTANT MEDICA

4/6/12 5 HOUR ENERGY 

EXTRA STRENGTH GRAPE

4/6/12 5 HOUR ENERGY 

BERRY

150937 4/6/12 5 HOUR ENERGY CONVULSION OTHER SERIOUS (IMPORTANT MEDICA152471 5/15/12 FIVE HOUR ENERGY 

BOOSTER

DIARRHOEA, VOMITING, CHROMATURIA, JAUNDICE, PRURITUS, ANOREXIA, BILIARY SPHINCTEROTOMY, CHOLESTASIS, GALLBLADDER DISORDER, PANCREATIC DISORDER

OTHER SERIOUS (IMPORTANT MEDICAHOSPITALIZATION

153005 6/1/12 5 HOUR ENERGY 

BERRY

ABDOMINAL PAIN UPPER, VOMITING, BACK PAIN, DIARRHOEA HAEMORRHAGIC, GASTRIC DISORDER, GASTRIC HAEMORRHAGE

HOSPITALIZATION, VISITED AN ER, OT(IMPORTANT MEDICAL EVENTS)

7/19/128/31/127/24/1210/17/12

155222 8/7/12 5-HOUR ENERGY COELIAC DISEASE HOSPITALIZATION155230 8/7/12 5 HOUR ENERGY COMPLETED SUICIDE DEATH154669^ 5-HOUR ENERGY 

GRAPE

ERYTHEMA, PRURITUS, TONGUE OEDEMA, URTICARIA, OBSTRUCTIVE AIRWAYS DISORDER, DYSPHAGIA

VISITED AN ER, LIFE THREATENING

150936^ FATIGUE, MIGRAINE, DIZZINESS, NAUSEA, AGITATION, HOSPITALIZATION

DEPENDENCE, MALAISE, DRUG WITHDRAWAL SYNDROME, FEELING ABNORMAL

VISITED AN ER, OTHER SERIOUS (IMPMEDICAL EVENTS)

154568^ 5-HOUR ENERGY 

POMEGRANA TE

LOSS OF CONSCIOUSNESS, HEAD INJURY, DIZZINESS, CONCUSSION, TREMOR, CONVULSION, BRAIN OEDEMA

Page 9
Report # Received 

Date

Brand/ Product 

Name

Symptoms Outcomes

9/10/129/28/12

156366 9/10/12 5 HOUR ENERGY 

BERRY

FEELING ABNORMAL, SOMNOLENCE, LOSS OF CONSCIOUSNESS, COMA, DRUG TOXICITY

HOSPITALIZATION, OTHER SERIOUS (MEDICAL EVENTS)

156368 9/10/12 5 HOUR ENERGY HEART RATE IRREGULAR, MYOCARDIAL INFARCTION OTHER SERIOUS (IMPORTANT MEDICA157207 10/1/12 5 HOUR ENERGY SUDDEN CARDIAC DEATH, FATIGUE, LOSS OF 

CONSCIOUSNESS, MYOCARDIAL INFARCTION

DEATH

157210 9/28/12 5-HOUR ENERGY METABOLIC ACIDOSIS, SYSTEMIC INFLAMMATORY 

RESPONSE SYNDROME, BRONCHOSPASM, HEPATIC ENZYME INCREASED, INSOMNIA, MYOGLOBIN BLOOD INCREASED, MANIA

OTHER SERIOUS (IMPORTANT MEDICA

158006 10/22/12 5-HOUR ENERGY MOTOR DYSFUNCTION, CONVULSION OTHER SERIOUS (IMPORTANT MEDICA92156365^ 5 HOUR ENERGY HOSPITALISATION HOSPITALIZATION

Page 10
Report # Received Date Brand/Product

Name

Symptoms Outcomes

66354 2/4/04 MONSTER ENERGY 

ENERGY SUPPLEMENT DRINK

ABDOMINAL PAIN UPPER, RETCHING, VOMITING, DIARRHOEA, WEIGHT DECREASED, DIZZINESS, HOSPITALISATION

LIFE THREATENING, HOSPITALIZATION

71234 8/11/04 MONSTER ENERGY 

DRINK

MYOCARDIAL INFARCTION, ELECTROCARDIOGRAM ST SEGMENT ELEVATION, HOSPITALISATION

HOSPITALIZATION, LIFE THREATENING

75388 1/10/05 MONSTER BEVERAGE 

CO MONSTER ENERGY

FATIGUE VISITED A HEALTH CARE PROVIDER

78111 4/6/05 HANSENS MONSTER 

ENERGY DRINK

PHARYNGITIS, DIZZINESS NON-SERIOUS INJURIES/ ILLNESS

86237 3/22/06 MONSTER ENERGY 

DRINK

TREMOR, DYSPNOEA, VOMITING, CHEST PAIN, TREMOR, RHABDOMYOLYSIS, MYOCLONUS

HOSPITALIZATION, VISITED AN ER, LIFE THREATENING

111857 4/7/09 MONSTER ENERGY 

DRINK

DEATH DEATH

112784 4/7/09 MONSTER BLUE LOW 

CARB ENERGY DRINK

NAUSEA, THROAT IRRITATION NON-SERIOUS INJURIES/ ILLNESS

 ^ Additional dates indicate receipt of additional materials on report.

CAERS Adverse Events Reports Allegedly Related to Monster

Search Terms: Monster

The Center for Food Safety Adverse Event Reporting System (CAERS) is a post-market surveillance system that collects reports about events or probrelated to CFSAN regulated products. In some reports, information in the reports cannot be verified for accuracy. Furthermore, in many reports, indivother products, and many products contain multiple ingredients which further complicates the evaluation of adverse event reports.There is no certainty that a reported adverse event can be attributed to a particular product or ingredient. The number of adverse event reports in CAEthe adverse event report itself about a particular product only reflects information AS REPORTED and does not represent any conclusion by FDA rerelationship or association with the product or ingredient. Due to the continuous inclusion of new or updated information into the CAERS system, repCAERS containing adverse event data may change over time.Each report received by CAERS regarding an individual that experiences an adverse event is assigned a unique report number (Report #). *Previous versions of this document may include CAERS reports 150942 and 150496. Since we received two CAERS reports for the same individualinto a single CAERS report (150942).

Page 1
Report # Received Date Brand/Product

Name

Symptoms Outcomes

113068 5/7/09 MONSTER ENERGY 

DRINK

BIPOLAR DISORDER, PSYCHOTIC DISORDER, PERSONALITY DISORDER, SUICIDAL IDEATION

HOSPITALIZATION

116885 6/2/09 JAVA MONSTER PLUS 

ENERGY ENERGY DRINK RUSSIAN FLAVOR

GASTROENTERITIS SALMONELLA, MALAISE, VOMITING, BACK PAIN, HEADACHE, ABDOMINAL PAIN, COUGH, DIARRHOEA

NON-SERIOUS INJURIES/ ILLNESS

128536 7/28/10 MONSTER ENERGY 

DRINK

FATIGUE, INFLUENZA LIKE ILLNESS, MEMORY IMPAIRMENT, MIGRAINE, ANGINA PECTORIS, PALPITATIONS, EYE PAIN, MALAISE, DYSURIA, NEUROPATHY PERIPHERAL, NIGHT SWEATS, DECREASED APPETITE, ASTHENIA, PAIN, INSOMNIA, HEADACHE, FLUSHING, VISUAL ACUITY REDUCED

LIFE THREATENING, HOSPITALIZATION

130690 10/5/10 MONSTER ENERGY 

DRINK

DYSPNOEA, POLLAKIURIA, BLOOD POTASSIUM DECREASED

VISITED AN ER, HOSPITALIZATION

11/12/106/21/12

133771 12/8/10 JAVA MONSTER MEAN 

BEAN COFFEE FLAVORED ENERGY DRINK

VOMITING, ABDOMINAL PAIN NON-SERIOUS INJURIES/ ILLNESS

142050 8/1/11 MONSTER ENERGY LETHARGY, ABDOMINAL PAIN, 

HEART RATE ABNORMAL

NON-SERIOUS INJURIES/ ILLNESS

143117 8/1/11 MONSTER/LOW CARB 

ENERGY DRINK

CONJUNCTIVITIS VISITED A HEALTH CARE PROVIDER, NON-SERIOUS INJURIE

144780 4/14/11 MONSTER HIT MAN 

ENERGY DRINK

NAUSEA, DIZZINESS, VOMITING, HEART RATE ABNORMAL, BLOOD PRESSURE FLUCTUATION

NON-SERIOUS INJURIES/ ILLNESS

132041^ MONSTER NITROUS DEATH DEATH

Page 2
Report # Received Date Brand/Product

Name

Symptoms Outcomes

145133 10/26/11 MONSTER DRINK MUSCLE SPASMS, ABASIA, 

DIZZINESS, MUSCULOSKELETAL STIFFNESS, DYSPNOEA, PAIN IN EXTREMITY

OTHER SERIOUS (IMPORTANT MEDICAL EVENTS)

145546 11/10/11 MONSTER ENERGY 

DRINK

HEART RATE ABNORMAL, SKIN DISCOLOURATION, BLOOD PRESSURE INCREASED

VISITED AN ER

12/7/113/27/124/4/12

146479 12/6/11 MONSTER ENERGY 

DRINK

HEART RATE IRREGULAR, DYSPNOEA, ATRIAL FIBRILLATION

HOSPITALIZATION

147297 12/30/11 MONSTER DEATH DEATH147873 12/5/11 MONSTER ENERGY 

DRINK

ABDOMINAL PAIN NON-SERIOUS INJURIES/ ILLNESS

150719 4/3/12 MONSTER ENERGY 

DRINK

FATIGUE, IRRITABILITY, DEPENDENCE

NON-SERIOUS INJURIES/ ILLNESS

150941 4/6/12 MONSTER TREMOR, RESPIRATORY RATE 

INCREASED

VISITED A HEALTH CARE PROVIDER, HOSPITALIZATION

3/27/124/9/12

151016 4/9/12 MONSTER ENERGY 

DRINKS

DYSPNOEA, CHEST PAIN VISITED AN ER, OTHER SERIOUS (IMPORTANT MEDICAL EVE

151782 4/27/12 MONSTER ENERGY 

REHAB PROTEAN + ENERGY 15.5 OZ

THROAT TIGHTNESS, HYPERSENSITIVITY

HOSPITALIZATION

152471 5/15/12 MONSTER ENERGY DIARRHOEA, VOMITING, 

CHROMATURIA, JAUNDICE, PRURITUS, ANOREXIA, BILIARY SPHINCTEROTOMY, CHOLESTASIS,GALLBLADDER DISORDER, PANCREATIC DISORDER

OTHER SERIOUS (IMPORTANT MEDICAL EVENTS), HOSPITALDEATH

146476^ MONSTER DRINKS LOSS OF CONSCIOUSNESS DEATH

*150942^ MONSTER ENERGY 

DRINK

CARDIAC ARREST, ARRHYTHMIA, DRUG TOXICITY

Page 3
Report # Received Date Brand/Product

Name

Symptoms Outcomes

153012 5/31/12 MONSTER ENERGY 

REHAB PROTEAN

RESPIRATORY ARREST, CARDIAC ARREST

HOSPITALIZATION

153279 6/11/12 MONSTER ENERGY 16 

OZ

DIZZINESS, TREMOR, ANXIETY HOSPITALIZATION

153974 6/29/12 MONSTER ENERGY 

IMPORT DUB EDITION

OROPHARYNGEAL SWELLING VISITED AN ER, HOSPITALIZATION

154641 7/20/12 MONSTER ENERGY 

IMPORT

CONFUSIONAL STATE, CHEST PAIN, PAIN, HEADACHE, CHILLS, DIZZINESS

VISITED AN ER, HOSPITALIZATION

155221 8/7/12 MONSTER ENERGY 16 

OZ

DYSPNOEA, FEELING JITTERY, HYPOAESTHESIA

HOSPITALIZATION

155267 8/8/12 MONSTER ENERGY HYPERSENSITIVITY, EMOTIONAL 

DISTRESS, URTICARIA

VISITED AN ER, HOSPITALIZATION

155411 8/10/12 MONSTER ENERGY 

DRINK

HYPERSENSITIVITY, MALAISE CONGENITAL ANOMALY, REQ. INTERVENTION TO PRVNT PE

THREATENING, DISABILITY

155735 8/22/12 MONSTER ENERGY HEART RATE INCREASED, 

PALPITATIONS, FALL

HOSPITALIZATION

155835 8/27/12 MONSTER ENERGY 

ANTI- GRAVITY 12 FL. OZ

ORAL HERPES, HYPERSENSITIVITY, RASH, PRURITUS

HOSPITALIZATION

156002 8/30/12 MONSTER ENERGY 

ABSOLUTELY ZERO

ABDOMINAL PAIN UPPER, VOMITING, SYNCOPE, DIARRHOEA, DEHYDRATION

HOSPITALIZATION

156830 9/20/12 MONSTER ENERGY CHOKING,

HAEMORRHAGE, FOREIGN BODY TRAUMA, RETCHING

VISITED AN ER, HOSPITALIZATION

157791 10/11/12 MONSTER ENERGY 

REHAB GREEN TEA15.5OZ

SYNCOPE, MYOCARDIAL INFARCTION, FOOD POISONING, DIZZINESS, FEELING ABNORMAL

VISITED A HEALTH CARE PROVIDER

40

Page 4
Report # Received 

Date

Brand/Product

Name

Symptoms O

83060 1/3/06 ROCKSTAR ENERGEY 

DRINK

NAUSEA NON-SERIOUS INJUR

86399 6/20/06 ROCKSTAR ENERGY 

FUEL

NAUSEA, HYPERHIDROSIS, HEART RATE INCREASED, OVERDOSE OTHER SERIOUS (IM

EVENTS)

87069 7/13/06 DIET ROCKSTAR 

ENERGY DRINK SOFT DRINK

INFLUENZA LIKE ILLNESS, ABDOMINAL DISTENSION, NAUSEA NON-SERIOUS INJUR

92129 3/19/07 DIET ROCK STAR HYPERTENSION, BLOOD PRESSURE INCREASED, HEART RATE 

INCREASED, SUPRAVENTRICULAR TACHYCARDIA

DISABILITY, VISITED 

100226 2/8/08 ROCKSTAR ENERGY 

DRINK

NAUSEA, DIZZINESS, HEADACHE, HEART RATE INCREASED, LOSS OF CONSCIOUSNESS, TACHYCARDIA, IRRITABILITY

HOSPITALIZATION

111130 3/9/09 ROCKSTAR ZERO 

CARB ENERGY DRINK

VOMITING, CRYING, ANXIETY VISITED A HEALTH C

AN ER

113062 5/7/09 ROCKSTAR ENERGY 

DRINK

MANIA, PSYCHOTIC DISORDER, INSOMNIA, BIPOLAR DISORDER VISITED AN ER, HOS

^ Additional dates indicate receipt of additional materials on report.

CAERS Adverse Events Reports Allegedly Related to Rockstar

Search Terms: Rockstar, Rock Star

The Center for Food Safety Adverse Event Reporting System (CAERS) is a post-market surveillance system that collects reports about evenallegedly related to CFSAN regulated products. In some reports, information in the reports cannot be verified for accuracy. Furthermore, in mmay have used other products, and many products contain multiple ingredients which further complicates the evaluation of adverse event repThere is no certainty that a reported adverse event can be attributed to a particular product or ingredient. The number of adverse event reportFDA and the adverse event report itself about a particular product only reflects information AS REPORTED and does not represent any conregarding a causal relationship or association with the product or ingredient. Due to the continuous inclusion of new or updated information reports released from CAERS containing adverse event data may change over time.Each report received by CAERS regarding an individual that experiences an adverse event is assigned a unique report number (Report #).

Page 1
Report # Received 

Date

Brand/Product

Name

Symptoms O

114915 7/1/09 ROCKSTAR ENERGY 

DRINK

ARTERIAL DISORDER, INFARCTION, CEREBROVASCULAR ACCIDENT, BIOPSY BLOOD VESSEL ABNORMAL

HOSPITALIZATION, D

116889 7/13/09 ROCK STAR ROASTED 

COFFEE AND ENERGY MOCHA AND CREAM COFFEE

LACERATION, THROAT IRRITATION VISITED AN ER, VISIT

PROVIDER

120455 5/19/08 ROCKSTAR JUICED 

ENERGY+ GUAVA ENERGY DRINK

NAUSEA, DIARRHOEA, VOMITING, BURNING SENSATION NON-SERIOUS INJUR

127121 6/1/10 ROCKSTAR ENERGY 

DRINK AND POWER SHOT

HEART RATE ABNORMAL, VOMITING, NERVOUSNESS VISITED AN ER

131960 9/24/10 ROCK STAR ENERGY 

DRINK

ABDOMINAL PAIN NON-SERIOUS INJUR

156595 9/13/12 ROCKSTAR INC 

ROCKSTAR ZERO CARB ZERO SUGAR

DYSGEUSIA NON-SERIOUS INJUR

13

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