What the label lists and what reports show

Pertuzumab side effects

Pertuzumab's FDA label: “The most common adverse reactions (> 30%) with PERJETA in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.” FAERS holds 27,027 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (3,802 reports).

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Check it at the source: the pertuzumab FDA label on DailyMed (effective April 30, 2026, Genentech, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
The most common adverse reactions (> 30%) with PERJETA in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.

Table 3: Adverse Reactions (≥ 10%) in Patients Who Received PERJETA in Combination with Trastuzumab and Docetaxel in CLEOPATRA

Reaction	All Grades %	Grades 3 – 4 %	All Grades %	Grades 3 – 4 %
Diarrhea	67	8	46	5
Nausea	42	1	42	0.5
Vomiting	24	1	24	2
Stomatitis	19	0.5	15	0.3
Constipation	15	0	25	1
Alopecia	61	0	60	0.3
Rash	34	0.7	24	0.8
Nail disorder	23	1	23	0.3
Pruritus	14	0	10	0
Dry skin	11	0	4	0
Neutropenia	53	49	50	46
Anemia	23	2	19	4
Leukopenia	18	12	20	15
Febrile neutropenia In this table this denotes an adverse reaction that has been reported…	14	13	8	7
Fatigue	37	2	37	3
Mucosal inflammation	28	1	20	1
Asthenia	26	2	30	2
Peripheral edema	23	0.5	30	0.8
Pyrexia	19	1	18	0.5
Neuropathy peripheral	32	3	34	2
Headache	21	1	17	0.5
Dysgeusia	18	0	16	0
Dizziness	13	0.5	12	0
Decreased appetite	29	2	26	2
Myalgia	23	1	24	0.8

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued
The following adverse reactions are discussed in greater detail in other sections of the label: Left Ventricular Dysfunction [see Warnings and Precautions (5.1) ] Embryo-Fetal Toxicity [see Warnings and Precautions (5.2) ] Infusion-Related Reactions [see Warnings and Precautions (5.3) ] Hypersensitivity Reactions/Anaphylaxis [see Warnings and Precautions (5.4) ] Metastatic Breast Cancer The most common adverse reactions (> 30%) with PERJETA in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy. ( 6.1 ) Neoadjuvant Treatment of Breast Cancer The most common adverse reactions (> 30%) with PERJETA in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia. ( 6.1 ) The most common adverse reactions (>30%) with PERJETA in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia. ( 6.1 ) The most common adverse reactions (>30%) with PERJETA in combination with docetaxel, carboplatin, and trastuzumab (TCH) were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia. …

Source: FDA drug label, Genentech, Inc., effective April 30, 2026 (SPL set 17f85d17-ab71-4f5b-9fe3-0b8c822f69ff), via openFDA; the full label on DailyMed

What do FAERS reports show?

27,027 reports list pertuzumab among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,685 are coded as a death and 9,119 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 17 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Diarrhoea (named in the label)3,802
Off Label Use (a use or a product term, not a reaction)2,368
Nausea (named in the label)1,958
Fatigue (named in the label)1,921
Alopecia (named in the label)1,569
Myelosuppression1,555
Disease Progression (a use or a product term, not a reaction)1,336
Vomiting (named in the label)1,298
Dyspnoea (named in the label)1,197
Neuropathy Peripheral (named in the label)1,123
Death (an outcome recorded in the report)1,104
Pyrexia (named in the label)1,065
Neutropenia (named in the label)1,007
Rash (named in the label)940
Anaemia (named in the label)885
Asthenia (named in the label)843
Headache (named in the label)777
Febrile Neutropenia (named in the label)752
Ejection Fraction Decreased (named in the label)717
Decreased Appetite (named in the label)702
Metastases To Central Nervous System641
Pain637
Pruritus (named in the label)616
Pneumonia609
No Adverse Event (a use or a product term, not a reaction)599

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Pertuzumab: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions