. 2021 Jul 28;8(4):589–601. doi: 10.1007/s40801-021-00262-7

Table 4.

Most frequently reported adverse drug reactions (ADRs) by Preferred Term per route of administration, and System Organ Class

MedDRA classification	ADR		ADRs/MDADs
MedDRA classification	N	%	ADRs/MDADs
*Preferred term*
Local route of administration
1. Eye irritation	409	14.1	0.23^a
2. Application site pain	279	9.6	0.15^a
3. Application site erythema	194	6.7	0.11^a
4. Ocular hyperaemia	176	6.1	0.10^a
5. Application site pruritus	131	4.5	0.07^a
6. Other	1711	59.0	0.95^a
Total	2900	100.0	1.61
Parenteral route of administration
1. Injection site inflammation	380	14.6	4.66^a
2. Injection site pruritus	52	3.4	0.64^a
3. Injection site erythema	50	3.2	0.61^a
4. Rash	49	3.2	0.60^a
5. Injection site nodule	48	3.1	0.59^a
6. Other	960	62.3	11.76
Total	1539	100.0	18.85
Oral route of administration
1. Nausea	58	5.5	0.03^a
2. Rash	50	4.7	0.03^a
3. Pruritus	44	4.2	0.02^a
4. Abdominal pain	30	2.8	0.02^a
5. Palpitations	27	2.5	0.02^a
6. Other	851	80.3	0.48^a
Total	1060	100.0	0.59
*System organ class*
1. General disorders and administration site conditions	1896	34.4	0.52^b
2. Eye disorders	1030	18.7	0.28^b
3. Skin and subcutaneous tissue disorders	981	17.8	0.27^b
4. Gastrointestinal disorders	448	8.1	0.12^b
5. Respiratory, thoracic and mediastinal disorders	221	4.0	0.06^b
6. Other	930	16.9	0.25^b
Total	5506	100.0	1.50

MDADs maximum daily administration doses sold

^aCalculated as number of ADRs/MDAD per route of administration × 1 million

^bCalculated as number of ADRs/total MDAD × 1 million