FDA Adverse Events Reports (FAERS) Summary for ACTIQ

These tables and charts are based on 25,271 total reports for ACTIQ (FENTANYL CITRATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 25,267 pharmaceutical company-submitted and non-U.S. FAERS reports and 4 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

Top 20 Adverse Effects Associated with ACTIQ (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DEATH	11440
2	TOXICITY TO VARIOUS AGENTS	9099
3	OVERDOSE	5536
4	DRUG DEPENDENCE	1756
5	DRUG ABUSE	1506
6	DRUG WITHDRAWAL SYNDROME NEONATAL	1280
7	ACCIDENTAL OVERDOSE	641
8	PAIN	438
9	FOETAL EXPOSURE DURING PREGNANCY	373
10	MATERNAL EXPOSURE DURING PREGNANCY	337
11	INTENTIONAL PRODUCT MISUSE	329
12	DRUG DIVERSION	272
13	OFF LABEL USE	204
14	TREMOR	178
15	DRUG WITHDRAWAL SYNDROME	150
16	DRUG INEFFECTIVE	147
17	DENTAL CARIES	146
18	CRYING	143
19	DRUG PRESCRIBING ERROR	142
20	DROWSINESS	139
21	VOMITING	139
22	NAUSEA	136
23	ACCIDENTAL DRUG INTAKE BY CHILD	132
24	LIVE BIRTH	129
25	POOR FEEDING INFANT	129
26	HEPATITIS C	128
27	OPISTHOTONUS	127
28	DEVELOPMENTAL DELAY	126
29	TOOTH LOSS	97
30	EXPOSURE DURING PREGNANCY	84
31	DEPRESSION	76
32	SHORTNESS OF BREATH	76
33	WITHDRAWAL SYNDROME	74
34	MALAISE	73
35	ANXIETY	68
36	LETHARGY	60
37	DIARRHEA	59
38	CONSTIPATION	57
39	FALL	57
40	FATIGUE	55
41	INSOMNIA	55
42	WEIGHT DECREASED	55
43	EXCESS SWEATING	53
44	HEADACHE	52
45	FEVER	52
46	PNEUMONIA	47
47	MEDICATION ERROR	45
48	LOSS OF CONSCIOUSNESS	44
49	TOOTH DISORDER	44
50	DEPENDENCE	43
51	LACK OF STRENGTH AND ENERGY (ASTHENIA)	41
52	CONFUSIONAL STATE	41
53	CONVULSION	41
54	DRUG TOXICITY	40
55	FEELING ABNORMAL	40
56	DIZZINESS	39
57	CANCER MALIGNANT	39
58	SUICIDAL IDEATION	39
59	ACCIDENTAL EXPOSURE	38
60	INCORRECT DOSE ADMINISTERED	38
61	PRODUCT USE IN UNAPPROVED INDICATION	38
62	PRODUCT USE ISSUE	38
63	CHEST PAIN	36
64	EMOTIONAL DISTRESS	36
65	ABDOMINAL PAIN	35
66	BACK PAIN	35
67	CANCER PROGRESSION	35
68	ADVERSE EVENT	34
69	LOW BLOOD PRESSURE	34
70	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	33
71	TOOTH FRACTURE	33
72	ANEMIA	31
73	DEHYDRATION	31
74	DISEASE PROGRESSION	30
75	CONDITION AGGRAVATED	29
76	DRY MOUTH	29
77	INTENTIONAL DRUG MISUSE	29
78	PAIN IN EXTREMITY	29
79	HALLUCINATION	28
80	HIGH BLOOD PRESSURE	28
81	MUSCLE SPASMS	28
82	JOINT PAIN	27
83	SUBSTANCE ABUSE	27
84	ABDOMINAL PAIN UPPER	26
85	DRUG EFFECT DECREASED	26
86	PRODUCT QUALITY ISSUE	26
87	SUICIDE ATTEMPT	26
88	AGITATION	25
89	COMA	25
90	SLURRED SPEECH	25
91	COMPLETED SUICIDE	24
92	GENERAL PHYSICAL HEALTH DETERIORATION	24
93	HOSPITALIZATION	24
94	SWELLING OF LIMBS	24
95	PINS AND NEEDLES	24
96	DECREASED APPETITE	23
97	DRUG INTERACTION	23
98	ITCHING	23
99	TOOTH ABSCESS	23
100	WRONG TECHNIQUE IN DRUG USAGE PROCESS	23

Latest Known Outcomes for Reactions Reported for ACTIQ

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Patient died	19459
2	Unknown Outcome	5084
3	Patient has not recovered/symtoms have not resolved	1144
4	Patient recovered	193
5	Patient is recovering/symptoms resolving	59
6	Patient has recovered but has consequent health issues	7

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2004	82
2005	129
2006	127
2007	199
2008	182
2009	177
2010	124
2011	123
2012	258
2013	236
2014	213
2015	97
2016	83
2017	1735
2018	20580
2019	65
2020	691
2021	96
2022	21
2023	17
2024	13
2025	20
2026	3

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	197
11-20	70
21-30	100
31-40	138
41-50	236
51-60	276
61-70	177
71-80	72
81-90	27
91+	10

Based on 1303 reports that included a patient age.

ACTIQ Total Reports

Male	Female	Unknown	Total
1027	1697	22547	25,271

Top Countries Reporting

	Country	Number of Reports
1	United States	23735
2	France	74
3	Spain	42
4	South Korea	15
5	Italy	14
6	United Kingdom	13
7	Germany	9
8	EU	9
9	Netherlands	8
10	Switzerland	7

Outcomes for Reports

Serious: 24567
Not Serious: 704
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Top Companies Reporting

TEVA

Safety-Related FDA Updates

FDA Approval Date: 1998-11-04

Actiq (FENTANYL CITRATE) Rx Drug:
Shared FDA Risk Evaluation and Mitigation Strategy REMS

ACTIQ (FENTANYL CITRATE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with ACTIQ? Rate ACTIQ at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for ACTIQ reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.