FDA Adverse Events Reports (FAERS) Summary for CLARITIN-D 24 HOUR

These tables and charts are based on 3,308 total reports for CLARITIN-D 24 HOUR (LORATADINE\PSEUDOEPHEDRINE SULFATE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 3,287 pharmaceutical company-submitted and non-U.S. FAERS reports and 21 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 21 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch CLARITIN-D 24 HOUR summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with CLARITIN-D 24 HOUR (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DRUG INEFFECTIVE	818
2	INSOMNIA	399
3	DRUG EFFECT DECREASED	281
4	PRODUCT USE ISSUE	247
5	DROWSINESS	159
6	DIZZINESS	133
7	DRY MOUTH	118
8	PALPITATIONS	109
9	FEELING ABNORMAL	107
10	OFF LABEL USE	94
11	HEADACHE	92
12	FEELING JITTERY	91
13	EXTRA DOSE ADMINISTERED	84
14	PRODUCT USE IN UNAPPROVED INDICATION	79
15	NAUSEA	67
16	DRUG EFFECT DELAYED	66
17	NERVOUSNESS	64
18	HEART RATE INCREASED	62
19	POOR QUALITY SLEEP	62
20	DRUG EFFECT INCREASED	62
21	UNEVALUABLE EVENT	62
22	FATIGUE	53
23	BLOOD PRESSURE INCREASED	52
24	SHORTNESS OF BREATH	51
25	DRUG EFFECT INCOMPLETE	50
26	EXPIRED PRODUCT ADMINISTERED	48
27	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	46
28	ANXIETY	44
29	OVERDOSE	42
30	MALAISE	41
31	RUNNY NOSE	39
32	CONDITION AGGRAVATED	38
33	DRUG INEFFECTIVE FOR UNAPPROVED INDICATION	33
34	CONSTIPATION	31
35	PAINFUL URINATION	31
36	INCORRECT DOSE ADMINISTERED	31
37	TREMOR	30
38	VOMITING	30
39	INCORRECT PRODUCT ADMINISTRATION DURATION	29
40	ABDOMINAL DISCOMFORT	27
41	ACCIDENTAL EXPOSURE TO PRODUCT BY CHILD	27
42	DIARRHEA	26
43	NASAL DRYNESS	26
44	ACCIDENTAL OVERDOSE	25
45	COUGH	25
46	HYPERSENSITIVITY	25
47	PSYCHOMOTOR HYPERACTIVITY	23
48	RASH	23
49	DECREASED APPETITE	22
50	EXCESS SWEATING	22
51	INCORRECT DRUG ADMINISTRATION DURATION	22
52	LACK OF STRENGTH AND ENERGY (ASTHENIA)	21
53	CHEST PAIN	21
54	WATERING EYES	21
55	PRODUCT PRESCRIBING ISSUE	21
56	ABDOMINAL PAIN UPPER	20
57	DRUG HYPERSENSITIVITY	20
58	THIRST	20
59	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	19
60	ADVERSE DRUG REACTION	18
61	AGITATION	18
62	DRUG EFFECTIVE FOR UNAPPROVED INDICATION	18
63	HIGH BLOOD PRESSURE	17
64	NASAL CONGESTION	17
65	SNEEZING	17
66	CHEST DISCOMFORT	16
67	INITIAL INSOMNIA	16
68	PAIN	16
69	ITCHING	16
70	RESTLESSNESS	16
71	SLEEP DISORDER	16
72	CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR	15
73	NUMBNESS	15
74	DRUG DEPENDENCE	14
75	THERAPEUTIC RESPONSE DECREASED	14
76	THERAPEUTIC RESPONSE SHORTENED	14
77	ADVERSE EVENT	13
78	DRUG SCREEN POSITIVE	13
79	ENERGY INCREASED	13
80	DRUG EFFECT INCOMPLETE	13
81	MIDDLE INSOMNIA	12
82	PAIN IN EXTREMITY	12
83	URINATION DIFFICULTY	12
84	THROAT IRRITATION	12
85	BACK PAIN	11
86	CONFUSIONAL STATE	11
87	DEPRESSION	11
88	INDIGESTION	11
89	ITCHY EYES	11
90	MUSCLE SPASMS	11
91	FACIAL SWELLING	11
92	WRONG TECHNIQUE IN DRUG USAGE PROCESS	11
93	ABDOMINAL PAIN	10
94	DISTURBANCE IN ATTENTION	10
95	DRY THROAT	10
96	HALLUCINATION	10
97	HEAD DISCOMFORT	10
98	IRRITABILITY	10
99	THROAT PAIN	10
100	URINARY RETENTION	10

Latest Known Outcomes for Reactions Reported for CLARITIN-D 24 HOUR

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	2452
2	Patient recovered	422
3	Patient has not recovered/symtoms have not resolved	247
4	Patient is recovering/symptoms resolving	55
5	Patient has recovered but has consequent health issues	3
6	Patient died	2

Search all MedWatch and FAERS by keyword:

CLARITIN-D 24 HOUR Total Reports

Male	Female	Unknown	Total
965	2070	273	3,308

Top Countries Reporting

	Country	Number of Reports
1	United States	3143
2	Canada	3

Outcomes for Reports

Serious: 240
Not Serious: 3068
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

Hypersensitivity
Allergic respiratory symptom
Product used for unknown indication
Nutritional supplementation
COMMON COLD

Top Companies Reporting

Safety-Related FDA Updates

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

Notes

This report, created by AskaPatient.com, is derived from the cases for CLARITIN-D 24 HOUR 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 April 28, 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.