FDA Adverse Events Reports (FAERS) Summary for NORDITROPIN

These tables and charts are based on 4,034 total reports for NORDITROPIN (SOMATROPIN) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 2,994 pharmaceutical company-submitted and non-U.S. FAERS reports and 1,040 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 1,040 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch NORDITROPIN summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

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

	Side Effect	# of FDA Reports
1	HEADACHE	189
2	OFF LABEL USE	141
3	HOSPITALIZATION	128
4	FATIGUE	103
5	CONDITION AGGRAVATED	102
6	DEATH	98
7	VOMITING	93
8	NAUSEA	90
9	FEVER	87
10	INJECTION SITE PAIN	82
11	JOINT PAIN	81
12	DRUG INEFFECTIVE	73
13	THERAPY INTERRUPTED	72
14	SEIZURE	69
15	PRODUCT USE IN UNAPPROVED INDICATION	66
16	PRODUCT DOSE OMISSION ISSUE	65
17	THERAPY CESSATION	63
18	PAIN	61
19	INCORRECT DOSE ADMINISTERED	57
20	DIARRHEA	55
21	MALAISE	55
22	WEIGHT INCREASED	54
23	DRUG DOSE OMISSION	53
24	FALL	51
25	INSOMNIA	51
26	PAIN IN EXTREMITY	51
27	PNEUMONIA	50
28	BRAIN TUMOUR	49
29	PRODUCT STORAGE ERROR	49
30	RASH	49
31	DIZZINESS	43
32	SLEEP APNEA	42
33	CONVULSION	40
34	DEPRESSION	40
35	SCOLIOSIS	38
36	WEIGHT DECREASED	38
37	DROWSINESS	37
38	ANXIETY	36
39	LACK OF STRENGTH AND ENERGY (ASTHENIA)	36
40	LOWER LIMBS SWELLING	36
41	OSTEOCHONDROSIS	35
42	BLOOD GLUCOSE INCREASED	34
43	DECREASED APPETITE	34
44	PRODUCT DOSE OMISSION	34
45	HIVES	34
46	EPILEPSY	33
47	HYPERSENSITIVITY	33
48	CRANIOPHARYNGIOMA	32
49	SHORTNESS OF BREATH	32
50	COVID-19	31
51	AGGRESSION	30
52	BACK PAIN	30
53	BRUISE	30
54	LOW BLOOD SUGAR	30
55	INJECTION SITE BRUISING	30
56	ABDOMINAL PAIN UPPER	29
57	FEELING ABNORMAL	29
58	SWELLING OF LIMBS	29
59	PAPILLOEDEMA	29
60	CHEST PAIN	28
61	HIGH BLOOD PRESSURE	28
62	SURGERY	28
63	DEHYDRATION	27
64	PRODUCT DISPENSING ERROR	27
65	LOSS OF CONSCIOUSNESS	25
66	ABNORMAL BEHAVIOUR	24
67	ASTHMA	24
68	CONSTIPATION	24
69	INFECTION	24
70	COMMON COLD	24
71	PRODUCT USE ISSUE	24
72	ITCHING	24
73	PULMONARY HYPERTENSION	24
74	TYPE 1 DIABETES MELLITUS	24
75	BLOOD PRESSURE INCREASED	23
76	STROKE	23
77	COUGH	23
78	DISEASE RECURRENCE	23
79	INTRACRANIAL PRESSURE INCREASED	23
80	MUSCLE PAIN	23
81	URINARY TRACT INFECTION	23
82	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	23
83	ANEMIA	22
84	NOSEBLEED	22
85	EXCESS SWEATING	22
86	ILLNESS	22
87	MEMORY IMPAIRMENT	22
88	SINUSITIS	22
89	FAINTING	22
90	ABDOMINAL PAIN	21
91	EPIPHYSIOLYSIS	21
92	HEART RATE INCREASED	21
93	NEOPLASM RECURRENCE	21
94	NO ADVERSE EVENT	21
95	ADRENOCORTICAL INSUFFICIENCY ACUTE	20
96	MIGRAINE	20
97	CANCER MALIGNANT	20
98	OVERDOSE	20
99	PRODUCT QUALITY ISSUE	20
100	SEPSIS	20

Latest Known Outcomes for Reactions Reported for NORDITROPIN

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	1261
2	Patient recovered	631
3	Patient has not recovered/symtoms have not resolved	571
4	Patient is recovering/symptoms resolving	193
5	Patient died	93
6	Patient has recovered but has consequent health issues	28

Search all MedWatch and FAERS by keyword:

NORDITROPIN Total Reports

Male	Female	Unknown	Total
2150	1672	212	4,034

Top Countries Reporting

	Country	Number of Reports
1	United States	2107
2	United Kingdom	225
3	Canada	205
4	Japan	192
5	France	83
6	Germany	80
7	Turkey	48
8	Israel	35
9	Brazil	30
10	EU	27

Outcomes for Reports

Serious: 2786
Not Serious: 1248
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

Growth hormone deficiency
Product used for unknown indication
Hypopituitarism
Short stature
Noonan syndrome

Top Companies Reporting

NOVO NORDISK

Safety-Related FDA Updates

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.

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 NORDITROPIN 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.