Buprenorphine Hydrochloride, Naloxone Hydrochloride

Common brands: Suboxone, Oxycontin, Hydrocodone Bitartrate And Acetaminophen, Neurontin, Oxycodone Hydrochloride

Top reporter: Indivior Inc.

Benzodiazepine [EPC]Partial Opioid Agonist [EPC]Opioid Agonist [EPC]Nonsteroidal Anti-inflammatory Drug [EPC]Atypical Antipsychotic [EPC]
23,840
Total Reports
5,920
Serious Reports
1,254
Death Reports
30
Reported Reactions
Death Report Ratio: High (5.26%)

Patient Demographics

Male
10,020
Female
10,040

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Buprenorphine Hydrochloride, Naloxone Hydrochloride.

# Reaction Reports % of Total
1 DRUG DEPENDENCE 4,290
11.2%
2 DRUG WITHDRAWAL SYNDROME 3,338
8.8%
3 PAIN 2,558
6.7%
4 OFF LABEL USE 2,071
5.4%
5 OVERDOSE 1,858
4.9%
6 NAUSEA 1,639
4.3%
7 EMOTIONAL DISTRESS 1,478
3.9%
8 ANXIETY 1,353
3.5%
9 VOMITING 1,341
3.5%
10 HEADACHE 1,114
2.9%
11 DRUG ABUSE 1,104
2.9%
12 INSOMNIA 1,076
2.8%
13 FOETAL EXPOSURE DURING PREGNANCY 1,049
2.8%
14 DEPRESSION 1,030
2.7%
15 INTENTIONAL UNDERDOSE 1,026
2.7%
16 FEELING ABNORMAL 1,014
2.7%
17 SUBSTANCE ABUSE 1,006
2.6%
18 PRODUCT USE ISSUE 978
2.6%
19 DRUG WITHDRAWAL SYNDROME NEONATAL 908
2.4%
20 WRONG TECHNIQUE IN PRODUCT USAGE PROCESS 805
2.1%
21 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION 784
2.1%
22 FATIGUE 775
2.0%
23 PRODUCT PREPARATION ERROR 775
2.0%
24 MATERNAL EXPOSURE DURING PREGNANCY 736
1.9%
25 MALAISE 726
1.9%
26 HYPERHIDROSIS 716
1.9%
27 WRONG TECHNIQUE IN DRUG USAGE PROCESS 662
1.7%
28 DENTAL CARIES 652
1.7%
29 DRUG INEFFECTIVE 648
1.7%
30 DIARRHOEA 631
1.7%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. A reported reaction does not mean the drug caused it. Drugs with more users naturally have more reports. Always consult your doctor or pharmacist before making medication decisions.