Drug

Lanadelumab-flyo

136 flagged reaction(s) · 5,900 total co-reports · max PRR 853.6

Important: Reactions below are the flagged terms from this drug’s FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate disproportionality in spontaneous reporting, not causation. Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.

	Reaction	Co-reports (a)	PRR	ROR	Signal
1	Hereditary Angioedema	1,197	853.6	1,372.1	signal
2	Pharyngeal Swelling	121	84.8	88.1	signal
3	Weight Fluctuation	84	53.8	55.3	signal
4	Insurance Issue	113	50.8	52.6	signal
5	Product Availability Issue	79	23.4	24.0	signal
6	Body Height Decreased	32	19.7	19.9	signal
7	Poor Venous Access	30	19.3	19.5	signal
8	Stress	138	12.7	13.3	signal
9	Seasonal Allergy	25	11.8	11.8	signal
10	Pregnancy	35	11.5	11.6	signal
11	Infusion Site Pain	22	11.4	11.5	signal
12	Treatment Noncompliance	92	11.2	11.5	signal
13	Intentional Product Use Issue	146	11.0	11.5	signal
14	Product Prescribing Error	39	10.9	11.1	signal
15	Complication Associated With Device	19	9.5	9.6	signal
16	Drug Effect Less Than Expected	19	8.9	9.0	signal
17	Limb Injury	33	8.1	8.2	signal
18	Ligament Sprain	12	8.1	8.1	signal
19	Therapy Change	11	7.6	7.6	signal
20	Inability To Afford Medication	11	7.4	7.4	signal
21	Prescribed Overdose	21	7.2	7.2	signal
22	Weight Increased	239	7.1	7.6	signal
23	Product Prescribing Issue	21	6.8	6.9	signal
24	Injection Site Urticaria	25	6.8	6.9	signal
25	Inappropriate Schedule Of Product Administration	178	6.7	7.0	signal
26	Product Dose Omission Issue	273	6.4	6.9	signal
27	Skin Laceration	10	6.1	6.2	signal
28	Expired Product Administered	30	6.0	6.0	signal
29	Weight Decreased	234	5.6	5.9	signal
30	Product Use Issue	156	5.5	5.8	signal
31	Abdominal Distension	86	5.5	5.6	signal
32	Kidney Infection	16	5.4	5.4	signal
33	Illness	81	5.3	5.5	signal
34	Ovarian Cyst	8	5.3	5.3	signal
35	Temperature Intolerance	8	5.2	5.2	signal
36	Product Dose Omission In Error	21	5.2	5.2	signal
37	Nephrolithiasis	35	5.1	5.1	signal
38	Dysmenorrhoea	10	5.1	5.1	signal
39	Influenza	84	5.0	5.1	signal
40	Device Related Infection	11	4.7	4.7	signal
41	Injection Site Irritation	9	4.7	4.7	signal
42	Road Traffic Accident	29	4.6	4.6	signal
43	Swelling Face	44	4.5	4.5	signal
44	Swelling	63	4.5	4.5	signal
45	Gastroenteritis Viral	12	4.4	4.4	signal
46	Gastrointestinal Disorder	57	4.3	4.3	signal
47	Swollen Tongue	20	4.2	4.3	signal
48	Viral Infection	21	4.2	4.2	signal
49	Needle Issue	18	4.2	4.2	signal
50	Injection Site Reaction	43	4.2	4.2	signal
51	No Adverse Event	110	4.1	4.2	signal
52	Gastroenteritis	9	4.1	4.1	signal
53	Injection Site Swelling	46	4.0	4.1	signal
54	Condition Aggravated	182	4.0	4.2	signal
55	Incorrect Route Of Product Administration	10	3.9	4.0	signal
56	Covid-19	104	3.9	4.0	signal
57	Injection Site Bruising	46	3.9	3.9	signal
58	Product Use Complaint	9	3.8	3.9	signal
59	Joint Dislocation	6	3.8	3.8	signal
60	Ear Infection	15	3.7	3.8	signal
61	Pharyngitis	7	3.7	3.7	signal
62	Brain Oedema	7	3.7	3.7	signal
63	Toothache	10	3.7	3.7	signal
64	Procedural Pain	15	3.6	3.6	signal
65	Tooth Infection	7	3.5	3.5	signal
66	Dermatitis Contact	6	3.5	3.5	signal
67	Spinal Disorder	5	3.5	3.5	signal
68	Migraine	49	3.4	3.5	signal
69	Musculoskeletal Chest Pain	8	3.4	3.4	signal
70	Syringe Issue	9	3.4	3.4	signal
71	Injection Site Erythema	63	3.4	3.4	signal
72	Accident	6	3.3	3.3	signal
73	Bladder Disorder	5	3.3	3.3	signal
74	Localised Infection	12	3.3	3.3	signal
75	Tooth Disorder	11	3.3	3.3	signal
76	Tooth Abscess	5	3.2	3.2	signal
77	Poor Quality Product Administered	5	3.2	3.2	signal
78	Injection Site Pain	148	3.2	3.3	signal
79	Sinusitis	50	3.2	3.3	signal
80	Scratch	5	3.2	3.2	signal
81	Post Procedural Complication	9	3.1	3.1	signal
82	Joint Injury	10	3.1	3.1	signal
83	Product Use In Unapproved Indication	114	3.1	3.2	signal
84	Pharyngitis Streptococcal	5	3.1	3.1	signal
85	Angioedema	20	3.0	3.0	signal
86	Sars-cov-2 Test Positive	6	3.0	3.0	signal
87	Nerve Compression	4	2.9	2.9	no signal
88	Aphonia	6	2.9	2.9	signal
89	Intestinal Obstruction	16	2.8	2.8	signal
90	Spinal Pain	5	2.8	2.8	signal
91	Lip Swelling	14	2.8	2.8	signal
92	Wrist Fracture	5	2.8	2.8	signal
93	Crying	15	2.7	2.7	signal
94	Urticaria	68	2.7	2.7	signal
95	Fear	11	2.7	2.7	signal
96	Eye Swelling	15	2.7	2.7	signal
97	Product Storage Error	35	2.7	2.7	signal
98	Anaphylactic Reaction	22	2.7	2.7	signal
99	Salivary Hypersecretion	4	2.7	2.7	no signal
100	Depressed Mood	21	2.6	2.7	signal
101	Therapy Interrupted	27	2.6	2.6	signal
102	Injection Site Discomfort	4	2.6	2.6	no signal
103	Exposure During Pregnancy	24	2.6	2.6	signal
104	Burning Sensation	27	2.6	2.6	signal
105	Pharyngeal Oedema	6	2.5	2.6	signal
106	Underdose	28	2.5	2.6	signal
107	Ill-defined Disorder	23	2.5	2.5	signal
108	Abdominal Pain Lower	9	2.4	2.4	signal
109	Post Procedural Haemorrhage	4	2.3	2.3	no signal
110	Systemic Lupus Erythematosus	12	2.2	2.3	signal
111	Injection Site Pruritus	22	2.2	2.2	signal
112	Injection Site Rash	10	2.2	2.2	signal
113	Lymphoma	5	2.1	2.1	no signal
114	Hernia	6	2.1	2.1	no signal
115	Injection Site Induration	4	2.0	2.0	no signal
116	Adverse Event	28	2.0	2.0	signal
117	Circumstance Or Information Capable Of Leading To Medication Error	10	2.0	2.0	no signal
118	Influenza Like Illness	24	1.9	1.9	no signal
119	Breast Pain	3	1.9	1.9	no signal
120	Application Site Pain	6	1.8	1.8	no signal
121	Maternal Exposure During Pregnancy	24	1.8	1.8	no signal
122	Incorrect Product Administration Duration	5	1.6	1.6	no signal
123	Hepatic Cytolysis	3	1.6	1.6	no signal
124	Injection Site Mass	9	1.6	1.6	no signal
125	Injection Site Discolouration	3	1.6	1.6	no signal
126	Product Preparation Error	5	1.6	1.6	no signal
127	Injection Site Extravasation	3	1.6	1.6	no signal
128	Menstruation Irregular	6	1.5	1.5	no signal
129	Therapeutic Response Shortened	7	1.5	1.5	no signal
130	Injection Site Haemorrhage	15	1.3	1.3	no signal
131	Abortion Spontaneous	7	1.2	1.2	no signal
132	Device Issue	15	1.1	1.1	no signal
133	Injury Associated With Device	3	1.0	1.0	no signal
134	Injection Site Warmth	3	1.0	1.0	no signal
135	Breast Cancer	11	0.8	0.8	no signal
136	Application Site Erythema	3	0.8	0.8	no signal