FDA Adverse Events Reports (FAERS) Summary for SANDIMMUNE

These tables and charts are based on 2,690 total reports for SANDIMMUNE (CYCLOSPORINE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 2,608 pharmaceutical company-submitted and non-U.S. FAERS reports and 82 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.

For a separate summary of the 82 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch SANDIMMUNE summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	FEVER	223
2	BLOOD CREATININE INCREASED	187
3	DEATH	126
4	KIDNEY FAILURE	112
5	KIDNEY IMPAIRMENT	112
6	DIARRHEA	99
7	DRUG INTERACTION	99
8	SEPSIS	98
9	SHORTNESS OF BREATH	97
10	CYTOMEGALOVIRUS INFECTION	91
11	HIGH BLOOD PRESSURE	91
12	PNEUMONIA	91
13	NAUSEA	90
14	VOMITING	88
15	HEADACHE	81
16	RENAL FAILURE ACUTE	80
17	ABDOMINAL PAIN	69
18	RASH	68
19	RESPIRATORY FAILURE	67
20	ANEMIA	65
21	GRAFT VERSUS HOST DISEASE	64
22	ALT LIVER ENZYME INCREASED	58
23	KIDNEY TRANSPLANT REJECTION	58
24	C-REACTIVE PROTEIN INCREASED	57
25	DRUG INEFFECTIVE	57
26	MALAISE	57
27	FATIGUE	55
28	INFECTION	55
29	URINARY TRACT INFECTION	55
30	MULTI-ORGAN FAILURE	54
31	PLATELET COUNT DECREASED	54
32	ASPARTATE AMINOTRANSFERASE INCREASED	52
33	BLOOD BILIRUBIN INCREASED	52
34	CONDITION AGGRAVATED	52
35	COUGH	52
36	LACK OF STRENGTH AND ENERGY (ASTHENIA)	50
37	CONFUSIONAL STATE	50
38	PAIN	50
39	NEPHROPATHY TOXIC	49
40	GENERAL PHYSICAL HEALTH DETERIORATION	48
41	BLOOD UREA INCREASED	47
42	CONVULSION	47
43	TRANSPLANT REJECTION	47
44	DEPRESSED LEVEL OF CONSCIOUSNESS	45
45	PANCYTOPENIA	45
46	THROMBOTIC MICROANGIOPATHY	42
47	SKIN REDNESS	41
48	HAEMOGLOBIN DECREASED	40
49	IMMUNOSUPPRESSANT DRUG LEVEL INCREASED	40
50	LEUKOPENIA	40
51	MUSCLE PAIN	40
52	SWELLING OF LIMBS	40
53	PAIN IN EXTREMITY	40
54	PLEURAL EFFUSION	40
55	ITCHING	40
56	HEART FAILURE	39
57	TREMOR	39
58	JOINT PAIN	38
59	KIDNEY DISORDER	38
60	DROWSINESS	38
61	RHABDOMYOLYSIS	37
62	BLOOD CREATINE PHOSPHOKINASE INCREASED	36
63	BLOOD LACTATE DEHYDROGENASE INCREASED	36
64	THROMBOCYTOPENIA	36
65	WEIGHT DECREASED	36
66	WHITE BLOOD CELL COUNT DECREASED	36
67	DIZZINESS	34
68	DRUG LEVEL INCREASED	34
69	FALL	34
70	GASTROINTESTINAL BLEEDING	34
71	SWELLING	34
72	WEIGHT INCREASED	34
73	RAPID HEART RATE (TACHYCARDIA)	33
74	GAMMA-GLUTAMYLTRANSFERASE INCREASED	32
75	ACUTE GRAFT VERSUS HOST DISEASE	31
76	BLOOD ALKALINE PHOSPHATASE INCREASED	31
77	BLOOD PRESSURE INCREASED	31
78	GAIT DISTURBANCE	31
79	HAEMODIALYSIS	31
80	SURGERY	31
81	ABDOMINAL PAIN UPPER	30
82	STROKE	30
83	FEBRILE NEUTROPENIA	30
84	LIVER FAILURE	30
85	LIVER FUNCTION ABNORMAL	30
86	LOW BLOOD PRESSURE	30
87	ATRIAL FIBRILLATION	29
88	DEHYDRATION	29
89	SWOLLEN ABDOMEN	27
90	CHEST PAIN	27
91	CHOLESTASIS	27
92	LIVER FUNCTION TEST ABNORMAL	27
93	BLOOD PRESSURE DECREASED	26
94	BONE MARROW FAILURE	26
95	CHILLS	26
96	DISORIENTATION	26
97	ELEVATED LIVER ENZYMES	26
98	HISTIOCYTOSIS HAEMATOPHAGIC	26
99	IMMUNOSUPPRESSANT DRUG LEVEL DECREASED	26
100	LIVER DISORDER	26

Latest Known Outcomes for Reactions Reported for SANDIMMUNE

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	453
2	Patient recovered	180
3	Patient died	146
4	Patient has not recovered/symtoms have not resolved	115
5	Patient is recovering/symptoms resolving	87
6	Patient has recovered but has consequent health issues	4

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2004	183
2005	202
2006	162
2007	170
2008	267
2009	253
2010	273
2011	295
2012	124
2013	50
2014	97
2015	106
2016	66
2017	59
2018	76
2019	85
2020	59
2021	45
2022	35
2023	37
2024	28
2025	12
2026	6

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	116
11-20	121
21-30	100
31-40	174
41-50	224
51-60	327
61-70	278
71-80	128
81-90	19
91+	9

Based on 1496 reports that included a patient age.

SANDIMMUNE Total Reports

Male	Female	Unknown	Total
1406	1151	133	2,690

Top Countries Reporting

	Country	Number of Reports
1	United States	460
2	Japan	74
3	Switzerland	41
4	Germany	35
5	France	29
6	Italy	28
7	Netherlands	10
8	Norway	10
9	Canada	9
10	Taiwan	9

Outcomes for Reports

Serious: 2502
Not Serious: 188
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

Product used for unknown indication
Renal transplant
Prophylaxis against graft versus host disease
Oral lichen planus
Immunosuppression

Top Companies Reporting

Safety-Related FDA Updates

FDA Approval Date: 1983-11-14

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 SANDIMMUNE 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.