FDA Adverse Events Reports (FAERS) Summary for SOMA

These tables and charts are based on 10,783 total reports for SOMA (CARISOPRODOL) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 10,486 pharmaceutical company-submitted and non-U.S. FAERS reports and 297 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 297 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch SOMA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	PAIN	1194
2	NAUSEA	963
3	DRUG INEFFECTIVE	954
4	HEADACHE	812
5	FATIGUE	707
6	ANXIETY	687
7	DEPRESSION	669
8	INSOMNIA	659
9	FALL	586
10	VOMITING	575
11	DRUG DEPENDENCE	570
12	SHORTNESS OF BREATH	548
13	BACK PAIN	546
14	DIARRHEA	523
15	DIZZINESS	523
16	MALAISE	480
17	PAIN IN EXTREMITY	475
18	JOINT PAIN	469
19	OVERDOSE	446
20	WEIGHT DECREASED	444
21	LACK OF STRENGTH AND ENERGY (ASTHENIA)	417
22	FEELING ABNORMAL	411
23	MUSCLE SPASMS	388
24	DROWSINESS	365
25	CHEST PAIN	361
26	DRUG WITHDRAWAL SYNDROME	361
27	WEIGHT INCREASED	350
28	HIGH BLOOD PRESSURE	347
29	TREMOR	320
30	OFF LABEL USE	319
31	EXCESS SWEATING	314
32	PNEUMONIA	308
33	NUMBNESS	305
34	FEVER	293
35	GAIT DISTURBANCE	290
36	CONSTIPATION	284
37	RASH	272
38	LOSS OF CONSCIOUSNESS	268
39	ITCHING	268
40	MIGRAINE	264
41	DRUG HYPERSENSITIVITY	255
42	MEMORY IMPAIRMENT	255
43	SUICIDAL IDEATION	255
44	ABDOMINAL PAIN	249
45	SWELLING OF LIMBS	248
46	CONDITION AGGRAVATED	246
47	DRUG DOSE OMISSION	241
48	ABDOMINAL PAIN UPPER	234
49	COUGH	233
50	PINS AND NEEDLES	232
51	DECREASED APPETITE	220
52	HEART ATTACK (MYOCARDIAL INFARCTION)	220
53	CONFUSIONAL STATE	211
54	VISION BLURRED	210
55	EMOTIONAL DISTRESS	203
56	MUSCLE PAIN	201
57	ROAD TRAFFIC ACCIDENT	201
58	AMNESIA	195
59	URINARY TRACT INFECTION	195
60	GASTROOESOPHAGEAL REFLUX DISEASE	194
61	INJURY	192
62	STROKE	190
63	PRODUCT QUALITY ISSUE	190
64	WRONG TECHNIQUE IN DRUG USAGE PROCESS	185
65	CONVULSION	184
66	DEHYDRATION	182
67	BLOOD PRESSURE INCREASED	180
68	DEATH	179
69	KIDNEY FAILURE	177
70	BRONCHITIS	175
71	ANEMIA	174
72	BRUISE	173
73	SINUSITIS	172
74	PALPITATIONS	170
75	NECK PAIN	166
76	ABDOMINAL DISCOMFORT	165
77	NERVOUSNESS	164
78	INJECTION SITE PAIN	163
79	DRUG ABUSE	162
80	FIBROMYALGIA	159
81	INTERVERTEBRAL DISC PROTRUSION	155
82	BALANCE DISORDER	149
83	STRESS	148
84	MUSCULAR WEAKNESS	146
85	WITHDRAWAL SYNDROME	146
86	NEUROPATHY PERIPHERAL	145
87	ARTHRITIS	144
88	INFLUENZA LIKE ILLNESS	144
89	CHILLS	142
90	DRY MOUTH	142
91	HYPERSENSITIVITY	141
92	DIABETES MELLITUS	140
93	IRRITABILITY	136
94	DEEP VEIN THROMBOSIS	134
95	COMMON COLD	133
96	LOW BLOOD PRESSURE	131
97	INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION	131
98	AGITATION	130
99	HAIR LOSS	130
100	UNEVALUABLE EVENT	130

Latest Known Outcomes for Reactions Reported for SOMA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	4472
2	Patient has not recovered/symtoms have not resolved	2150
3	Patient recovered	1676
4	Patient is recovering/symptoms resolving	649
5	Patient died	336
6	Patient has recovered but has consequent health issues	35

Search all MedWatch and FAERS by keyword:

SOMA Total Reports

Male	Female	Unknown	Total
2889	7610	284	10,783

Top Countries Reporting

	Country	Number of Reports
1	United States	6463
2	Taiwan	10
3	Ireland	7
4	United Kingdom	2
5	United Arab Emirates	1
6	Australia	1
7	India	1
8	Sweden	1

Outcomes for Reports

Serious: 6574
Not Serious: 4209
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

PFIZER
PFIZER
IPSEN BIOPHARMACEUTICALS, INC.
SANDOZ
IPSEN
PFIZER
ROCHE
TAKEDA
PFIZER

Safety-Related FDA Updates

SOMA (CARISOPRODOL) Rx Drug:
Safety-related Labeling Changes

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

HUMATROPE (SOMATROPIN RECOMBINANT) Rx Drug:
In pediatric patients, Slipped capital femoral epiphysis may lead to osteonecrosis. Safety-related Labeling Changes

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

SAIZEN (SOMATROPIN RECOMBINANT) Rx Drug:
Safety-related Labeling Changes

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

ZOMACTON (SOMATROPIN RECOMBINANT) Discontinued Drug:
Safety-related Labeling Changes

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

NUTROPIN (SOMATROPIN RECOMBINANT) Rx Drug:
In pediatric patients, Slipped capital femoral epiphysis may lead to osteonecrosis. Safety-related Labeling Changes

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

GENOTROPIN (SOMATROPIN RECOMBINANT) Rx Drug:
In pediatric patients, Slipped capital femoral epiphysis may lead to osteonecrosis. Safety-related Labeling Changes

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

NUTROPIN AQ (SOMATROPIN RECOMBINANT) Discontinued Drug:
In pediatric patients, Slipped capital femoral epiphysis may lead to osteonecrosis. Safety-related Labeling Changes

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

SEROSTIM (SOMATROPIN RECOMBINANT) Discontinued Drug:
Safety-related Labeling Changes

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

NORDITROPIN (SOMATROPIN RECOMBINANT) Rx Drug:
Gynecomastia warning. Do not store NORDITROPIN directly next to the cooling element in the refrigerator. Slipped capital femoral epiphysis reported, pediatric patients. Safety-related Labeling Changes

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

OMNITROPE (SOMATROPIN RECOMBINANT) Rx Drug:
In pediatric patients, Slipped capital femoral epiphysis may lead to osteonecrosis. Safety-related Labeling Changes

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

SOGROYA (SOMAPACITAN-BECO) Biological Drug:
In pediatric patients, Slipped capital femoral epiphysis may lead to osteonecrosis. Safety-related Labeling Changes

Have experience (good or bad) with SOGROYA? Rate SOGROYA 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 SOMA 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.