FDA Adverse Events Reports (FAERS) Summary for INDERAL LA

These tables and charts are based on 1,436 total reports for INDERAL LA (PROPRANOLOL HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 1,392 pharmaceutical company-submitted and non-U.S. FAERS reports and 44 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 44 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch INDERAL LA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	NAUSEA	128
2	DRUG INEFFECTIVE	111
3	FATIGUE	102
4	HEADACHE	95
5	DIZZINESS	92
6	VOMITING	83
7	FALL	72
8	PAIN	69
9	INSOMNIA	67
10	SHORTNESS OF BREATH	66
11	DIARRHEA	62
12	ANXIETY	60
13	MALAISE	56
14	LACK OF STRENGTH AND ENERGY (ASTHENIA)	52
15	CONDITION AGGRAVATED	50
16	DEPRESSION	49
17	BACK PAIN	48
18	LOW BLOOD PRESSURE	47
19	BLOOD PRESSURE INCREASED	46
20	JOINT PAIN	45
21	DRUG HYPERSENSITIVITY	45
22	CHEST PAIN	44
23	HIGH BLOOD PRESSURE	43
24	TREMOR	43
25	WEIGHT INCREASED	43
26	OFF LABEL USE	42
27	CONSTIPATION	41
28	PALPITATIONS	41
29	ABDOMINAL PAIN	39
30	FEELING ABNORMAL	38
31	PAIN IN EXTREMITY	36
32	CONFUSIONAL STATE	35
33	DECREASED APPETITE	35
34	MIGRAINE	35
35	MUSCLE SPASMS	33
36	FEVER	33
37	ABDOMINAL DISTENSION	32
38	HYPERSENSITIVITY	32
39	MUSCLE PAIN	31
40	RASH	30
41	DEPRESSED MOOD	29
42	ITCHING	29
43	ABDOMINAL DISCOMFORT	27
44	HEART RATE INCREASED	27
45	DROWSINESS	27
46	DRY MOUTH	26
47	MUSCULOSKELETAL STIFFNESS	26
48	URINARY TRACT INFECTION	26
49	SWELLING OF LIMBS	25
50	HAIR LOSS	24
51	PNEUMONIA	24
52	ABDOMINAL PAIN UPPER	23
53	ARTHRITIS	23
54	COUGH	23
55	FLUSHING	23
56	LOSS OF CONSCIOUSNESS	23
57	MEMORY IMPAIRMENT	23
58	BRUISE	22
59	OSTEOARTHRITIS	22
60	SINUSITIS	22
61	VERTIGO	22
62	VISION BLURRED	22
63	GAIT DISTURBANCE	21
64	EXCESS SWEATING	21
65	DEATH	20
66	EMOTIONAL DISTRESS	20
67	WEIGHT DECREASED	20
68	ANEMIA	19
69	CHILLS	19
70	HEART RATE DECREASED	19
71	PINS AND NEEDLES	19
72	BLOOD GLUCOSE INCREASED	18
73	CHEST DISCOMFORT	18
74	INJURY	18
75	COMMON COLD	18
76	PRODUCT USE IN UNAPPROVED INDICATION	18
77	DIFFICULTY SWALLOWING	17
78	INJECTION SITE BRUISING	17
79	INTERVERTEBRAL DISC DEGENERATION	17
80	PHARMACEUTICAL PRODUCT COMPLAINT	17
81	WATERING EYES	16
82	MUSCULAR WEAKNESS	16
83	HEART ATTACK (MYOCARDIAL INFARCTION)	16
84	PSORIASIS	16
85	KIDNEY FAILURE	16
86	SEIZURE	16
87	BLOOD PRESSURE DECREASED	15
88	DEEP VEIN THROMBOSIS	15
89	DRY SKIN	15
90	ITCHY EYES	15
91	INFLUENZA LIKE ILLNESS	15
92	INJECTION SITE PAIN	15
93	LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES	15
94	PANIC ATTACK	15
95	PARKINSON^S DISEASE	15
96	PRODUCT DOSE OMISSION ISSUE	15
97	PSORIATIC ARTHRITIS	15
98	PULMONARY EMBOLISM	15
99	BALANCE DISORDER	14
100	STROKE	14

Latest Known Outcomes for Reactions Reported for INDERAL LA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	580
2	Patient has not recovered/symtoms have not resolved	276
3	Patient recovered	225
4	Patient is recovering/symptoms resolving	86
5	Patient died	34
6	Patient has recovered but has consequent health issues	6

Search all MedWatch and FAERS by keyword:

INDERAL LA Total Reports

Male	Female	Unknown	Total
364	1013	59	1,436

Top Countries Reporting

	Country	Number of Reports
1	United States	770
2	Canada	84
3	United Kingdom	20
4	South Africa	4
5	Netherlands	3
6	Switzerland	2
7	Ireland	2
8	Japan	2
9	Brazil	1
10	Germany	1

Outcomes for Reports

Serious: 882
Not Serious: 553
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

Safety-Related FDA Updates

FDA Approval Date: 1983-04-19

INDERAL LA (PROPRANOLOL HYDROCHLORIDE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with INDERAL LA? Rate INDERAL LA 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

This report, created by AskaPatient.com, is derived from the cases for INDERAL LA 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.