FDA Adverse Events Reports (FAERS) Summary for CLARAVIS

These tables and charts are based on 7,309 total reports for CLARAVIS (ISOTRETINOIN) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 7,193 pharmaceutical company-submitted and non-U.S. FAERS reports and 116 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 116 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch CLARAVIS summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	UNINTENDED PREGNANCY	1816
2	DEPRESSION	748
3	SUICIDAL IDEATION	489
4	MOOD ALTERED	343
5	ANXIETY	323
6	DRUG EXPOSURE DURING PREGNANCY	296
7	INFLAMMATORY BOWEL DISEASE	278
8	HEADACHE	254
9	JOINT PAIN	239
10	DRY SKIN	220
11	MISCARRIAGE	191
12	BLOOD TRIGLYCERIDES INCREASED	187
13	TREATMENT NONCOMPLIANCE	186
14	MATERNAL EXPOSURE DURING PREGNANCY	181
15	ABORTION INDUCED	160
16	LIP DRY	158
17	MOOD SWINGS	140
18	ACNE	138
19	DEPRESSED MOOD	120
20	DRUG INEFFECTIVE	120
21	FATIGUE	118
22	BACK PAIN	104
23	PREGNANCY	104
24	ABDOMINAL PAIN	102
25	NOSEBLEED	101
26	SUICIDE ATTEMPT	92
27	MALAISE	90
28	NAUSEA	89
29	MUSCLE PAIN	86
30	DIARRHEA	84
31	COLITIS ULCERATIVE	80
32	RASH	80
33	MENTAL DISORDER	79
34	PREGNANCY TEST FALSE POSITIVE	79
35	BLOOD CHOLESTEROL INCREASED	78
36	DIZZINESS	78
37	OFF LABEL USE	77
38	DRY EYE	76
39	EXPOSURE DURING PREGNANCY	76
40	HAIR LOSS	70
41	ANGER	69
42	ELEVATED LIVER ENZYMES	68
43	VISION BLURRED	67
44	INSOMNIA	65
45	IRRITABILITY	64
46	AGGRESSION	63
47	PAIN	62
48	VAGINAL HAEMORRHAGE	61
49	CHAPPED LIPS	60
50	CRYING	55
51	RECTAL BLEEDING	55
52	CROHN^S DISEASE	54
53	FEELING ABNORMAL	52
54	BLOOD IN STOOL	52
55	VOMITING	52
56	ASPARTATE AMINOTRANSFERASE INCREASED	51
57	IRRITABLE BOWEL SYNDROME	51
58	ADVERSE EVENT	47
59	SELF-INJURIOUS IDEATION	46
60	STRESS	46
61	ABDOMINAL PAIN UPPER	42
62	DECREASED APPETITE	42
63	PREGNANCY ON ORAL CONTRACEPTIVE	42
64	ALT LIVER ENZYME INCREASED	41
65	DRUG DOSE OMISSION	40
66	LIVER FUNCTION TEST ABNORMAL	40
67	ABNORMAL BEHAVIOUR	39
68	CHEST PAIN	39
69	INTENTIONAL SELF-INJURY	39
70	EMOTIONAL DISORDER	37
71	MATERNAL EXPOSURE BEFORE PREGNANCY	37
72	COMPLETED SUICIDE	36
73	DISTURBANCE IN ATTENTION	36
74	SHORTNESS OF BREATH	36
75	LABORATORY TEST ABNORMAL	36
76	LACK OF STRENGTH AND ENERGY (ASTHENIA)	35
77	GASTROINTESTINAL DISORDER	35
78	COMMON COLD	35
79	PANIC ATTACK	34
80	ABDOMINAL DISCOMFORT	32
81	AFFECTIVE DISORDER	32
82	SKIN REDNESS	32
83	SURGERY	32
84	WEIGHT DECREASED	32
85	CHEILITIS	30
86	MIGRAINE	30
87	DRUG EXPOSURE BEFORE PREGNANCY	29
88	XEROSIS	28
89	HYPERSENSITIVITY	27
90	PREGNANCY WITH CONTRACEPTIVE DEVICE	27
91	PULMONARY EMBOLISM	27
92	VISUAL IMPAIRMENT	27
93	EMOTIONAL DISTRESS	26
94	EXPOSURE VIA BODY FLUID	26
95	ITCHING	26
96	FEVER	26
97	INJURY	25
98	PAIN IN EXTREMITY	25
99	ROAD TRAFFIC ACCIDENT	25
100	SKIN PEELING	25

Latest Known Outcomes for Reactions Reported for CLARAVIS

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	4153
2	Patient recovered	991
3	Patient has not recovered/symtoms have not resolved	518
4	Patient is recovering/symptoms resolving	227
5	Patient has recovered but has consequent health issues	35
6	Patient died	34

Search all MedWatch and FAERS by keyword:

CLARAVIS Total Reports

Male	Female	Unknown	Total
2097	4817	395	7,309

Top Countries Reporting

	Country	Number of Reports
1	United States	5370
2	Canada	3
3	Puerto Rico	3
4	France	1
5	United Kingdom	1
6	India	1
7	Mexico	1
8	Sweden	1
9	Ukraine	1

Outcomes for Reports

Serious: 4798
Not Serious: 2511
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
Acne

Top Companies Reporting

TEVA

Safety-Related FDA Updates

FDA Approval Date: 2003-04-11

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 CLARAVIS 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.