Hydrocodone Bitartrate / Acetaminophen

Common brands: Oxycontin, Dilaudid, Ms Contin, Oxycodone Hydrochloride, Roxicodone

Top reporter: Amneal Pharmaceuticals Llc

Nonsteroidal Anti-inflammatory Drug [EPC]Benzodiazepine [EPC]Opioid Agonist [EPC]Corticosteroid [EPC]Partial Opioid Agonist [EPC]

55,871

Total Reports

25,864

Serious Reports

8,198

Death Reports

Reported Reactions

Death Report Ratio: High (14.67%)

Patient Demographics

Male

27,245

Female

26,277

Reported Adverse Reactions (30)

Side effects reported in FDA adverse event reports for Hydrocodone Bitartrate / Acetaminophen.

#	Reaction	Reports	% of Total
1	DRUG DEPENDENCE	33,279	27.8%
2	OVERDOSE	14,496	12.1%
3	PAIN	12,028	10.1%
4	EMOTIONAL DISTRESS	10,823	9.1%
5	DRUG WITHDRAWAL SYNDROME	5,338	4.5%
6	ANXIETY	4,199	3.5%
7	DEATH	3,163	2.6%
8	DEPRESSION	2,726	2.3%
9	LEARNING DISABILITY	2,404	2.0%
10	FOETAL EXPOSURE DURING PREGNANCY	2,312	1.9%
11	DRUG ABUSE	2,247	1.9%
12	DEVELOPMENTAL DELAY	2,240	1.9%
13	DRUG WITHDRAWAL SYNDROME NEONATAL	2,213	1.9%
14	DISABILITY	1,764	1.5%
15	COMPLETED SUICIDE	1,750	1.5%
16	NAUSEA	1,599	1.3%
17	FATIGUE	1,557	1.3%
18	MENTAL DISORDER	1,491	1.2%
19	DRUG INEFFECTIVE	1,431	1.2%
20	INJURY	1,429	1.2%
21	DEPENDENCE	1,280	1.1%
22	CARDIAC DISORDER	1,176	1.0%
23	DIARRHOEA	1,160	1.0%
24	HEADACHE	1,128	0.9%
25	MATERNAL EXPOSURE DURING PREGNANCY	1,118	0.9%
26	CHRONIC KIDNEY DISEASE	1,093	0.9%
27	TOXICITY TO VARIOUS AGENTS	1,068	0.9%
28	FALL	1,009	0.8%
29	INSOMNIA	989	0.8%
30	UNEVALUABLE EVENT	989	0.8%

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.