DrugCite
Search

NALOXONE

Adverse Events
Drug Profile
Learn More
Reference
About Results
Comments

Naloxone Adverse Events Reported to the FDA Over Time

How are Naloxone adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Naloxone, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Naloxone is flagged as the suspect drug causing the adverse event.

Most Common Naloxone Adverse Events Reported to the FDA

What are the most common Naloxone adverse events reported to the FDA?

Age 10-19 Years

Loss Of Consciousness
16 (.04%)
Substance Abuse
16 (.04%)
Drug Withdrawal Syndrome
15 (.04%)
Overdose
15 (.04%)
Intentional Drug Misuse
12 (.03%)
Convulsion
11 (.03%)
Euphoric Mood
10 (.03%)
Vomiting
9 (.02%)
Depression
8 (.02%)
Drug Dependence
8 (.02%)
Drug Toxicity
8 (.02%)
Show More Show More
Insomnia
8 (.02%)
Death
7 (.02%)
Dehydration
7 (.02%)
Stress
7 (.02%)
Drug Exposure During Pregnancy
6 (.02%)
Headache
6 (.02%)
Underdose
6 (.02%)
Accidental Overdose
5 (.01%)
Back Pain
5 (.01%)
Confusional State
5 (.01%)
Dry Mouth
5 (.01%)
Hepatitis E
5 (.01%)
Hyperhidrosis
5 (.01%)
Incorrect Route Of Drug Administrat...
5 (.01%)
Mental Impairment
5 (.01%)
Osteitis
5 (.01%)
Osteomyelitis
5 (.01%)
Pain In Extremity
5 (.01%)
Paraesthesia
5 (.01%)
Pulmonary Oedema
5 (.01%)
Abortion Spontaneous
4 (.01%)
Completed Suicide
4 (.01%)
Dyspnoea
4 (.01%)
Extrapyramidal Disorder
4 (.01%)
Face Injury
4 (.01%)
Fall
4 (.01%)
Miosis
4 (.01%)
Muscular Weakness
4 (.01%)
Oral Pain
4 (.01%)
Pain
4 (.01%)
Restlessness
4 (.01%)
Rhinalgia
4 (.01%)
Torticollis
4 (.01%)
Apnoea
3 (.01%)
Brain Oedema
3 (.01%)
Cardiac Arrest
3 (.01%)
Drug Abuse
3 (.01%)
Nausea
3 (.01%)
Respiratory Arrest
3 (.01%)
Abdominal Pain Upper
2 (.01%)
Abortion
2 (.01%)
Alcohol Use
2 (.01%)
Breast Mass
2 (.01%)
Circulatory Collapse
2 (.01%)
Constipation
2 (.01%)
Discomfort
2 (.01%)
Dyskinesia
2 (.01%)
Epilepsy
2 (.01%)
Hand Fracture
2 (.01%)
Heart Rate Increased
2 (.01%)
Hepatic Encephalopathy
2 (.01%)
Hospitalisation
2 (.01%)
Intentional Overdose
2 (.01%)
Lung Infection
2 (.01%)
Papilloedema
2 (.01%)
Pyrexia
2 (.01%)
Respiratory Failure
2 (.01%)
Suicidal Ideation
2 (.01%)
Suicide Attempt
2 (.01%)
Therapy Naive
2 (.01%)
Unresponsive To Stimuli
2 (.01%)
Urinary Retention
2 (.01%)
Weight Decreased
2 (.01%)
Abasia
1 (0%)
Accidental Exposure
1 (0%)
Acute Psychosis
1 (0%)
Agitation
1 (0%)
Anger
1 (0%)
Anxiety
1 (0%)
Apallic Syndrome
1 (0%)
Arthralgia
1 (0%)
Back Disorder
1 (0%)
Blood Ph Decreased
1 (0%)
Brain Injury
1 (0%)
C-reactive Protein Increased
1 (0%)
Cardio-respiratory Arrest
1 (0%)
Cerebral Cyst
1 (0%)
Chest X-ray Abnormal
1 (0%)
Child Abuse
1 (0%)
Cyanosis
1 (0%)
Drug Abuser
1 (0%)
Drug Ineffective
1 (0%)
Drug Interaction
1 (0%)
Drug Screen Positive
1 (0%)
Electrolyte Imbalance
1 (0%)
Encephalopathy
1 (0%)
Epistaxis
1 (0%)
Fatigue
1 (0%)
Feeling Abnormal
1 (0%)
Gaze Palsy
1 (0%)

All Ages and Genders

Drug Withdrawal Syndrome
1197 (3.08%)
Insomnia
894 (2.3%)
Convulsion
761 (1.96%)
Suicidal Ideation
747 (1.92%)
Drug Exposure During Pregnancy
659 (1.7%)
Depression
635 (1.64%)
Vomiting
617 (1.59%)
Nausea
607 (1.56%)
Anxiety
556 (1.43%)
Pain
556 (1.43%)
Headache
555 (1.43%)
Show More Show More
Drug Dependence
516 (1.33%)
Loss Of Consciousness
464 (1.2%)
Hallucination
425 (1.1%)
Fatigue
418 (1.08%)
Hyperhidrosis
408 (1.05%)
Substance Abuse
407 (1.05%)
Back Pain
371 (.96%)
Intentional Drug Misuse
369 (.95%)
Oedema Peripheral
352 (.91%)
Somnolence
343 (.88%)
Dizziness
333 (.86%)
Decreased Appetite
312 (.8%)
Dyspnoea
310 (.8%)
Constipation
309 (.8%)
Malaise
294 (.76%)
Overdose
293 (.75%)
Fall
292 (.75%)
Pain In Extremity
259 (.67%)
Feeling Abnormal
255 (.66%)
Tremor
254 (.65%)
Diarrhoea
247 (.64%)
Abortion Spontaneous
245 (.63%)
Condition Aggravated
242 (.62%)
Road Traffic Accident
241 (.62%)
Asthenia
240 (.62%)
Pneumonia
235 (.61%)
Underdose
235 (.61%)
Off Label Use
206 (.53%)
Pyrexia
197 (.51%)
Chest Pain
182 (.47%)
Drug Withdrawal Syndrome Neonatal
181 (.47%)
Panic Attack
173 (.45%)
Abdominal Pain Upper
171 (.44%)
Death
170 (.44%)
Weight Decreased
167 (.43%)
Arthralgia
166 (.43%)
Euphoric Mood
166 (.43%)
Wrong Technique In Drug Usage Proce...
165 (.43%)
Suicide Attempt
162 (.42%)
Hypertension
158 (.41%)
Weight Increased
155 (.4%)
Muscle Spasms
154 (.4%)
Memory Impairment
151 (.39%)
Nervousness
148 (.38%)
Withdrawal Syndrome
143 (.37%)
Abdominal Pain
134 (.35%)
Myocardial Infarction
129 (.33%)
Confusional State
122 (.31%)
Amnesia
120 (.31%)
Premature Baby
119 (.31%)
Nasopharyngitis
118 (.3%)
Migraine
117 (.3%)
Drug Abuse
116 (.3%)
Intentional Overdose
113 (.29%)
Cerebrovascular Accident
111 (.29%)
Influenza
111 (.29%)
Dehydration
110 (.28%)
Agitation
109 (.28%)
Crying
109 (.28%)
Irritability
109 (.28%)
Paranoia
109 (.28%)
Blood Pressure Increased
108 (.28%)
Hallucination, Auditory
107 (.28%)
Stress
103 (.27%)
Drug Ineffective
102 (.26%)
Chills
97 (.25%)
Hypoaesthesia
97 (.25%)
Hospitalisation
95 (.24%)
Heart Rate Increased
92 (.24%)
Palpitations
92 (.24%)
Head Injury
88 (.23%)
Pruritus
88 (.23%)
Lethargy
85 (.22%)
Completed Suicide
83 (.21%)
Cardiac Arrest
81 (.21%)
Muscle Twitching
81 (.21%)
Vision Blurred
80 (.21%)
Tooth Disorder
78 (.2%)
Gait Disturbance
77 (.2%)
Neck Pain
77 (.2%)
Nightmare
76 (.2%)
Psychotic Disorder
76 (.2%)
Therapeutic Response Unexpected
75 (.19%)
Restlessness
74 (.19%)
Mental Disorder
73 (.19%)
Cardiac Disorder
72 (.19%)
Hypotension
71 (.18%)
Premature Labour
71 (.18%)
Thrombosis
71 (.18%)
Coma
70 (.18%)

ExportShare/Embed GraphExport Export Data

This graph shows the top adverse events submitted to the FDA for Naloxone, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Naloxone is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Naloxone

What are the most common Naloxone adverse events reported to the FDA?

Age 10-19 Years

Show More Show More

All Ages and Genders

Show More Show More

ExportShare/Embed Graph Export Export Data

This graph shows the top categories of adverse events submitted to the FDA for Naloxone, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Naloxone is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Naloxone According to Those Reporting Adverse Events

Why are people taking Naloxone, according to those reporting adverse events to the FDA?

Product Used For Unknown Indication
1951
Drug Dependence
1810
Drug Use For Unknown Indication
974
Pain
368
Back Pain
79
Drug Abuse
42
Show More Show More
Overdose
32
Dependence
31
Accidental Exposure
29
Pain Management
27
Drug Withdrawal Syndrome
23
Drug Therapy
21
Reversal Of Opiate Activity
17
Substance Abuse
16
Cancer Pain
14
Respiratory Depression
12
Arthralgia
12
Drug Detoxification
12
Drug Withdrawal Maintenance Therapy
11
Radiculopathy
10
Muscular Weakness
8
Analgesic Therapy
7
Pruritus
7
Drug Toxicity
7
Drug Level
7
Abdominal Pain
7
Sedation
7
Drug Exposure During Pregnancy
7
Depression
6
Detoxification
6
Constipation
5
Foetal Exposure During Pregnancy
5
Myalgia
5
Toxicity To Various Agents
5
Accidental Overdose
5
Therapeutic Agent Toxicity
4
Ill-defined Disorder
4
Suicide Attempt
4
Accidental Drug Intake By Child
4
Rheumatoid Arthritis
4
Neuralgia
4
Drug Abuser
4
Somnolence
4
Migraine
4
Reversal Of Sedation
4
Complex Regional Pain Syndrome
4
Pain In Extremity
3
Anaesthesia Reversal
3
Polysubstance Dependence
3
Analgesic Effect
3
Chest Discomfort
3

Child Safety Precautions


Drug Labels

LabelLabelerEffective
Pentazocine And NaloxonePD-Rx Pharmaceuticals, Inc.30-MAR-06
Naloxone HydrochloridePhysicians Total Care, Inc.03-MAY-10
Naloxone HydrochlorideMcKesson Packaging Services Business Unit of McKesson Corporation03-MAY-10
Pentazocine Hcl And Naloxone HclSTAT RX USA LLC21-JUN-10
Pentazocine And NaloxoneKeltman Pharmaceuticals Inc.20-JUL-10
Naloxone HydrochlorideGeneral Injectables & Vaccines, Inc24-AUG-10
Naloxone HydrochlorideGeneral Injectables & Vaccines, Inc24-AUG-10
Naloxone HydrochlorideGeneral Injectables & Vaccines, Inc08-SEP-10
Naloxone Hydrochloride Physicians Total Care, Inc.25-APR-11
Pentazocine Hydrochloride And Naloxone HydrochlorideGAVIS Pharmaceuticals, LLC14-JUN-11
Naloxone HydrochlorideHospira, Inc.11-JUL-11
Buprenorphine Hcl And Naloxone HclAmneal Pharmaceuticals29-DEC-11
SuboxonePD-Rx Pharmaceuticals, Inc.06-JAN-12
Pentazocine And NaloxoneGolden State Medical Supply, Inc.09-JAN-12
Naloxone Hydrochloride General Injectables & Vaccines, Inc.08-FEB-12
Naloxone HydrochlorideHospira, Inc.06-MAR-12
Naloxone HydrochlorideInternational Medication Systems, Limited 04-APR-12
SuboxoneLake Erie Medical & Surgical Supply DBA Quality Care Products LLC31-MAY-12
Pentazocine And NaloxoneWatson Laboratories, Inc.04-JUN-12
Pentazocine And NaloxoneLake Erie Medical & Surgical Supply DBA Quality Care Products LLC12-JUN-12
SuboxoneReckitt Benckiser Pharmaceuticals Inc10-AUG-12
SuboxoneBryant Ranch Prepack12-OCT-12
Naloxone Hydrochloride Amphastar Pharmaceuticals, Inc. 10-JAN-13
Naloxone HydrochlorideGeneral Injectables & Vaccines, Inc23-JAN-13
Buprenorphine Hydrochloride And Naloxone Hydrochloride DihydrateActavis Elizabeth LLC11-FEB-13
Pentazocine And NaloxoneBryant Ranch Prepack13-FEB-13
Naloxone HydrochlorideCardinal Health08-MAR-13
Buprenorphine Hcl And Naloxone Hcl AvKARE, Inc.01-APR-13
Naloxone HydrochlorideCardinal Health15-APR-13
Naloxone HydrochlorideCardinal Health30-APR-13

Naloxone Case Reports

What Naloxone safety concerns are being reported by doctors and researchers in the medical literature?

Powered by Google

About Results

This report contains aggregated drug side effects and adverse events for Naloxone. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

Comments

Share your experience with Naloxone.