PREMPRO® AND PREMPHASE® Adverse Reactions

(conjugated estrogens and medroxyprogesterone acetate)

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the labeling:

Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.1)]
Malignant Neoplasms [see Boxed Warning, Warnings and Precautions (5.2)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a 1-year clinical trial that included 678 postmenopausal women treated with PREMPRO and 351 postmenopausal women treated with PREMPHASE, the following adverse reactions occurred at a rate ≥ 1 percent, see Table 1.

TABLE 1: ALL TREATMENT RELATED ADVERSE REACTIONS AT A FREQUENCY ≥ 1 PERCENT
Body SystemPREMPRO
0.625 mg/2.5 mg
continuous
PREMPRO
0.625 mg/5 mg
continuous
PREMPHASE
0.625 mg/5 mg
sequential
  Adverse event (n = 340)(n = 338)(n = 351)

Body As A Whole

  Abdominal pain

35 (10%)

51 (15%)

58 (17%)

  Asthenia

13 (4%)

18 (5%)

21 (6%)

  Back pain

19 (6%)

16 (5%)

23 (7%)

  Chest pain

5 (1%)

4 (1%)

4 (1%)

  Flu syndrome

1 (<1%)

1 (<1%)

4 (1%)

  Generalized edema

12 (4%)

12 (4%)

8 (2%)

  Headache

64 (19%)

52 (15%)

66 (19%)

  Infection

2 (<1%)

4 (1)%

0

  Moniliasis

4 (1%)

3 (<1%)

4 (1%)

  Pain

12 (4%)

14 (4%)

15 (4%)

  Pelvic pain

11 (3%)

13 (4%)

16 (5%)

Cardiovascular System

  Hypertension

7 (2%)

7 (2%)

6 (2%)

  Migraine

6 (2%)

8 (2%)

7 (2%)

  Palpitation

2 (<1%)

3 (<1%)

4 (1%)

  Vasodilatation

2 (<1%)

7 (2%)

2 (<1%)

Digestive System

  Diarrhea

4 (1%)

3 (<1%)

7 (2%)

  Dyspepsia

5 (1%)

5 (1%)

7 (2%)

  Eructation

0

2 (<1%)

4 (1%)

  Flatulence

25 (7%)

27 (8%)

24 (7%)

  Increased appetite

1 (<1%)

5 (1%)

5 (1%)

  Nausea

26 (8%)

19 (6%)

26 (7%)

Metabolic and Nutritional

  Edema

5 (1%)

6 (2%)

3 (<1%)

  Glucose tolerance
  decreased

2 (<1%)

5 (1%)

4 (1%)

  Peripheral edema

11 (3%)

10 (3%)

11 (3%)

    Weight gain

9 (3%)

10 (3%)

11 (3%)

Musculoskeletal System

  Arthralgia

6 (2%)

2 (<1%)

7 (2%)

  Leg cramps

8 (2%)

11 (3%)

12 (3%)

Nervous System

  Depression

14 (4%)

26 (8%)

29 (8%)

  Dizziness

9 (3%)

8 (2%)

7 (2%)

  Emotional lability

5 (1%)

5 (1%)

6 (2%)

  Hypertonia

4 (1%)

4 (1%)

7 (2%)

  Insomnia

7 (2%)

6 (2%)

4 (1%)

  Nervousness

4 (1%)

9 (3%)

6 (2%)

Skin and Appendages

  Acne

1 (<1%)

5 (1%)

4 (1%)

  Alopecia

3 (<1%)

4 (1%)

0

  Dry skin

2 (<1%)

3 (<1%)

4 (1%)

  Pruritus

20 (6%)

18 (5%)

13 (4%)

  Rash

8 (2%)

6 (2%)

7 (2%)

  Sweating

2 (<1%)

4 (1%)

2 (<1%)

Urogenital System

  Breast engorgement

5 (1%)

5 (1%)

0

  Breast enlargement

14 (4%)

14 (4%)

14 (4%)

  Breast neoplasm

2 (<1%)

2 (<1%)

4 (1%)

  Breast pain

110 (32%)

123 (36%)

109 (31%)

  Cervix disorder

10 (3%)

6 (2%)

10 (3%)

  Dysmenorrhea

26 (8%)

18 (5%)

44 (13%)

  Leukorrhea

19 (6%)

13 (4%)

29 (8%)

  Menstrual disorder

7 (2%)

1 (<1%)

5 (1%)

  Menorrhagia

0

1 (<1%)

5 (1%)

  Metrorrhagia

13 (4%)

5 (1%)

7 (1%)

  Papanicolaou smear
  suspicious

5 (1%)

0

8 (2%)

  Urinary incontinence

4 (1%)

2 (<1%)

1 (<1%)

  Uterine spasm

7 (2%)

4 (1%)

7 (2%)

  Vaginal hemorrhage

5 (1%)

3 (<1%)

8 (2%)

  Vaginal moniliasis

5 (1%)

6 (2%)

7 (2%)

  Vaginitis

13 (4%)

13 (4%)

10 (3%)

In addition, phargyngitis and sinusitis were reported as two of the more frequent adverse events (>5 percent) in the PREMPRO clinical study. For pharyngitis, of the 121 events, six events were considered by the investigator causally related to study drug. For sinusitis, of the 73 events, one event was considered as casually related to study drug.

During the first year of a 2-year clinical trial with postmenopausal women between 40 and 65 years of age (88 percent Caucasian), 989 postmenopausal women received continuous regimens of PREMPRO, and 332 received placebo tablets. Table 2 summarizes adverse reactions that occurred at a rate ≥ 1 percent in at least 1 treatment group.

TABLE 2: ALL TREATMENT RELATED ADVERSE REACTIONS AT A FREQUENCY OF ≥ 1 PERCENT


Body System
Adverse event
PREMPRO
0.625/2.5
continuous
(N=331)
PREMPRO
0.45/1.5
continuous
(N=331)
PREMPRO
0.3/1.5
continuous
(N=327)

PLACEBO
daily
(N=332)

Any adverse event

214 (65)

208 (63)

188 (57)

164 (49)

Body as a Whole

  Abdominal pain

38 (11)

33 (10)

24 (7)

21 (6)

  Asthenia

11 (3)

11 (3)

12 (4)

3 (1)

  Back pain

12 (4)

12 (4)

8 (2)

4 (1)

  Chest pain

4 (1)

2 (1)

1 (0)

2 (1)

  Generalized edema

7 (2)

5 (2)

6 (2)

8 (2)

  Headache

45 (14)

45 (14)

57 (17)

46 (14)

  Moniliasis

3 (1)

6 (2)

4 (1)

1 (0)

  Pain

9 (3)

10 (3)

17 (5)

14 (4)

  Pelvic pain

9 (3)

7 (2)

5 (2)

4 (1)

Cardiovascular System

  Hypertension

2 (1)

3 (1)

1 (0)

5 (2)

  Migraine

11 (3)

8 (2)

5 (2)

3 (1)

  Palpitation

1 (0)

1 (0)

2 (1)

4 (1)

  Vasodilatation

0

3 (1)

1 (0)

5 (2)

Digestive System

  Constipation

5 (2)

7 (2)

6 (2)

3 (1)

  Diarrhea

5 (2)

2 (1)

6 (2)

8 (2)

  Dyspepsia

10 (3)

9 (3)

6 (2)

14 (4)

  Flatulence

16 (5)

18 (5)

13 (4)

8 (2)

  Increased appetite

6 (2)

2 (1)

0

2 (1)

  Nausea

13 (4)

13 (4)

16 (5)

16 (5)

Metabolic and nutritional

  Peripheral edema

7 (2)

8 (2)

4 (1)

3 (1)

  Weight gain

9 (3)

8 (2)

6 (2)

14 (4)

Musculoskeletal System

  Arthralgia

2 (1)

3 (1)

3 (1)

5 (2)

  Leg cramps

13 (4)

7 (2)

10 (3)

4 (1)

Nervous System

  Anxiety

5 (2)

4 (1)

1 (0)

4 (1)

  Depression

23 (7)

11 (3)

11 (3)

17 (5)

  Dizziness

3 (1)

8 (2)

6 (2)

5 (2)

  Emotional lability

10 (3)

10 (3)

9 (3)

8 (2)

  Insomnia

8 (2)

7 (2)

9 (3)

14 (4)

  Nervousness

6 (2)

3 (1)

4 (1)

6 (2)

Skin and Appendages

  Acne

7 (2)

3 (1)

0

3 (1)

  Alopecia

1 (0)

6 (2)

4 (1)

2 (1)

  Pruritus

8 (2)

10 (3)

9 (3)

3 (1)

  Rash

0

6 (2)

4 (1)

2 (1)

  Skin discoloration

5 (2)

1 (0)

3 (1)

1 (0)

  Sweating

3 (1)

1 (0)

0

4 (1)

Urogenital System

  Breast disorder

7 (2)

6 (2)

5 (2)

6 (2)

  Breast enlargement

18 (5)

9 (3)

5 (2)

3 (1)

  Breast neoplasm

8 (2)

7 (2)

5 (2)

7 (2)

  Breast pain

87 (26)

66 (20)

41 (13)

26 (8)

  Cervix disorder

7 (2)

2 (1)

2 (1)

0

  Dysmenorrhea

14 (4)

18 (5)

9 (3)

2 (1)

  Hematuria

4 (1)

3 (1)

1 (0)

2 (1)

  Leukorrhea

7 (2)

14 (4)

9 (3)

6 (2)

  Metrorrhagia

7 (2)

14 (4)

4 (1)

1 (0)

  Urinary tract infection

0

1 (0)

1 (0)

4 (1)

  Uterine spasm

13 (4)

11 (3)

7 (2)

2 (1)

  Vaginal dryness

2 (1)

1 (0)

0

6 (2)

  Vaginal hemorrhage

18 (5)

14 (4)

7 (2)

0

  Vaginal moniliasis

13 (4)

11 (3)

8 (2)

5 (2)

  Vaginitis

6 (2)

8 (2)

7 (2)

1 (0)

In addition, the following events were considered as related to the study drug with an incidence less than 1 percent, including accidental injury, infection, myalgia, cough increased, rhinitis, sinusitis, and upper respiratory infection.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of PREMPRO or PREMPHASE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Genitourinary System

Abnormal uterine bleeding, dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata, vaginitis, vaginal candidiasis, amenorrhea, changes in cervical secretion, ovarian cancer, endometrial hyperplasia, endometrial cancer.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes, breast cancer.

Cardiovascular

Deep and superficial venous thrombosis, pulmonary embolism, superficial thrombophlebitis, myocardial infarction, stroke, increase in blood pressure.

Gastrointestinal

Nausea, vomiting, abdominal pain, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis, changes in appetite, ischemic colitis.

Skin

Chloasma or melasma that may persist when drug is discontinued, erythema multiforme, erythema nodosum, loss of scalp hair, hirsutism, pruritus, urticaria, rash, acne.

Eyes

Retinal vascular thrombosis, intolerance of contact lenses.

Central Nervous System

Headache, migraine, dizziness, mental depression, exacerbation of chorea, mood disturbances, anxiety, irritability, exacerbation of epilepsy, dementia, growth potentiation of benign meningioma.

Miscellaneous

Increase or decrease in weight, arthralgia, glucose intolerance, edema, changes in libido, exacerbation of asthma, increased triglycerides, hypersensitivity.

Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.

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Adverse Reactions

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the labeling:

Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.1)]
Malignant Neoplasms [see Boxed Warning, Warnings and Precautions (5.2)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In a 1-year clinical trial that included 678 postmenopausal women treated with PREMPRO and 351 postmenopausal women treated with PREMPHASE, the following adverse reactions occurred at a rate ≥ 1 percent, see Table 1.

TABLE 1: ALL TREATMENT RELATED ADVERSE REACTIONS AT A FREQUENCY ≥ 1 PERCENT
Body SystemPREMPRO
0.625 mg/2.5 mg
continuous
PREMPRO
0.625 mg/5 mg
continuous
PREMPHASE
0.625 mg/5 mg
sequential
  Adverse event (n = 340)(n = 338)(n = 351)

Body As A Whole

  Abdominal pain

35 (10%)

51 (15%)

58 (17%)

  Asthenia

13 (4%)

18 (5%)

21 (6%)

  Back pain

19 (6%)

16 (5%)

23 (7%)

  Chest pain

5 (1%)

4 (1%)

4 (1%)

  Flu syndrome

1 (<1%)

1 (<1%)

4 (1%)

  Generalized edema

12 (4%)

12 (4%)

8 (2%)

  Headache

64 (19%)

52 (15%)

66 (19%)

  Infection

2 (<1%)

4 (1)%

0

  Moniliasis

4 (1%)

3 (<1%)

4 (1%)

  Pain

12 (4%)

14 (4%)

15 (4%)

  Pelvic pain

11 (3%)

13 (4%)

16 (5%)

Cardiovascular System

  Hypertension

7 (2%)

7 (2%)

6 (2%)

  Migraine

6 (2%)

8 (2%)

7 (2%)

  Palpitation

2 (<1%)

3 (<1%)

4 (1%)

  Vasodilatation

2 (<1%)

7 (2%)

2 (<1%)

Digestive System

  Diarrhea

4 (1%)

3 (<1%)

7 (2%)

  Dyspepsia

5 (1%)

5 (1%)

7 (2%)

  Eructation

0

2 (<1%)

4 (1%)

  Flatulence

25 (7%)

27 (8%)

24 (7%)

  Increased appetite

1 (<1%)

5 (1%)

5 (1%)

  Nausea

26 (8%)

19 (6%)

26 (7%)

Metabolic and Nutritional

  Edema

5 (1%)

6 (2%)

3 (<1%)

  Glucose tolerance
  decreased

2 (<1%)

5 (1%)

4 (1%)

  Peripheral edema

11 (3%)

10 (3%)

11 (3%)

    Weight gain

9 (3%)

10 (3%)

11 (3%)

Musculoskeletal System

  Arthralgia

6 (2%)

2 (<1%)

7 (2%)

  Leg cramps

8 (2%)

11 (3%)

12 (3%)

Nervous System

  Depression

14 (4%)

26 (8%)

29 (8%)

  Dizziness

9 (3%)

8 (2%)

7 (2%)

  Emotional lability

5 (1%)

5 (1%)

6 (2%)

  Hypertonia

4 (1%)

4 (1%)

7 (2%)

  Insomnia

7 (2%)

6 (2%)

4 (1%)

  Nervousness

4 (1%)

9 (3%)

6 (2%)

Skin and Appendages

  Acne

1 (<1%)

5 (1%)

4 (1%)

  Alopecia

3 (<1%)

4 (1%)

0

  Dry skin

2 (<1%)

3 (<1%)

4 (1%)

  Pruritus

20 (6%)

18 (5%)

13 (4%)

  Rash

8 (2%)

6 (2%)

7 (2%)

  Sweating

2 (<1%)

4 (1%)

2 (<1%)

Urogenital System

  Breast engorgement

5 (1%)

5 (1%)

0

  Breast enlargement

14 (4%)

14 (4%)

14 (4%)

  Breast neoplasm

2 (<1%)

2 (<1%)

4 (1%)

  Breast pain

110 (32%)

123 (36%)

109 (31%)

  Cervix disorder

10 (3%)

6 (2%)

10 (3%)

  Dysmenorrhea

26 (8%)

18 (5%)

44 (13%)

  Leukorrhea

19 (6%)

13 (4%)

29 (8%)

  Menstrual disorder

7 (2%)

1 (<1%)

5 (1%)

  Menorrhagia

0

1 (<1%)

5 (1%)

  Metrorrhagia

13 (4%)

5 (1%)

7 (1%)

  Papanicolaou smear
  suspicious

5 (1%)

0

8 (2%)

  Urinary incontinence

4 (1%)

2 (<1%)

1 (<1%)

  Uterine spasm

7 (2%)

4 (1%)

7 (2%)

  Vaginal hemorrhage

5 (1%)

3 (<1%)

8 (2%)

  Vaginal moniliasis

5 (1%)

6 (2%)

7 (2%)

  Vaginitis

13 (4%)

13 (4%)

10 (3%)

In addition, phargyngitis and sinusitis were reported as two of the more frequent adverse events (>5 percent) in the PREMPRO clinical study. For pharyngitis, of the 121 events, six events were considered by the investigator causally related to study drug. For sinusitis, of the 73 events, one event was considered as casually related to study drug.

During the first year of a 2-year clinical trial with postmenopausal women between 40 and 65 years of age (88 percent Caucasian), 989 postmenopausal women received continuous regimens of PREMPRO, and 332 received placebo tablets. Table 2 summarizes adverse reactions that occurred at a rate ≥ 1 percent in at least 1 treatment group.

TABLE 2: ALL TREATMENT RELATED ADVERSE REACTIONS AT A FREQUENCY OF ≥ 1 PERCENT


Body System
Adverse event
PREMPRO
0.625/2.5
continuous
(N=331)
PREMPRO
0.45/1.5
continuous
(N=331)
PREMPRO
0.3/1.5
continuous
(N=327)

PLACEBO
daily
(N=332)

Any adverse event

214 (65)

208 (63)

188 (57)

164 (49)

Body as a Whole

  Abdominal pain

38 (11)

33 (10)

24 (7)

21 (6)

  Asthenia

11 (3)

11 (3)

12 (4)

3 (1)

  Back pain

12 (4)

12 (4)

8 (2)

4 (1)

  Chest pain

4 (1)

2 (1)

1 (0)

2 (1)

  Generalized edema

7 (2)

5 (2)

6 (2)

8 (2)

  Headache

45 (14)

45 (14)

57 (17)

46 (14)

  Moniliasis

3 (1)

6 (2)

4 (1)

1 (0)

  Pain

9 (3)

10 (3)

17 (5)

14 (4)

  Pelvic pain

9 (3)

7 (2)

5 (2)

4 (1)

Cardiovascular System

  Hypertension

2 (1)

3 (1)

1 (0)

5 (2)

  Migraine

11 (3)

8 (2)

5 (2)

3 (1)

  Palpitation

1 (0)

1 (0)

2 (1)

4 (1)

  Vasodilatation

0

3 (1)

1 (0)

5 (2)

Digestive System

  Constipation

5 (2)

7 (2)

6 (2)

3 (1)

  Diarrhea

5 (2)

2 (1)

6 (2)

8 (2)

  Dyspepsia

10 (3)

9 (3)

6 (2)

14 (4)

  Flatulence

16 (5)

18 (5)

13 (4)

8 (2)

  Increased appetite

6 (2)

2 (1)

0

2 (1)

  Nausea

13 (4)

13 (4)

16 (5)

16 (5)

Metabolic and nutritional

  Peripheral edema

7 (2)

8 (2)

4 (1)

3 (1)

  Weight gain

9 (3)

8 (2)

6 (2)

14 (4)

Musculoskeletal System

  Arthralgia

2 (1)

3 (1)

3 (1)

5 (2)

  Leg cramps

13 (4)

7 (2)

10 (3)

4 (1)

Nervous System

  Anxiety

5 (2)

4 (1)

1 (0)

4 (1)

  Depression

23 (7)

11 (3)

11 (3)

17 (5)

  Dizziness

3 (1)

8 (2)

6 (2)

5 (2)

  Emotional lability

10 (3)

10 (3)

9 (3)

8 (2)

  Insomnia

8 (2)

7 (2)

9 (3)

14 (4)

  Nervousness

6 (2)

3 (1)

4 (1)

6 (2)

Skin and Appendages

  Acne

7 (2)

3 (1)

0

3 (1)

  Alopecia

1 (0)

6 (2)

4 (1)

2 (1)

  Pruritus

8 (2)

10 (3)

9 (3)

3 (1)

  Rash

0

6 (2)

4 (1)

2 (1)

  Skin discoloration

5 (2)

1 (0)

3 (1)

1 (0)

  Sweating

3 (1)

1 (0)

0

4 (1)

Urogenital System

  Breast disorder

7 (2)

6 (2)

5 (2)

6 (2)

  Breast enlargement

18 (5)

9 (3)

5 (2)

3 (1)

  Breast neoplasm

8 (2)

7 (2)

5 (2)

7 (2)

  Breast pain

87 (26)

66 (20)

41 (13)

26 (8)

  Cervix disorder

7 (2)

2 (1)

2 (1)

0

  Dysmenorrhea

14 (4)

18 (5)

9 (3)

2 (1)

  Hematuria

4 (1)

3 (1)

1 (0)

2 (1)

  Leukorrhea

7 (2)

14 (4)

9 (3)

6 (2)

  Metrorrhagia

7 (2)

14 (4)

4 (1)

1 (0)

  Urinary tract infection

0

1 (0)

1 (0)

4 (1)

  Uterine spasm

13 (4)

11 (3)

7 (2)

2 (1)

  Vaginal dryness

2 (1)

1 (0)

0

6 (2)

  Vaginal hemorrhage

18 (5)

14 (4)

7 (2)

0

  Vaginal moniliasis

13 (4)

11 (3)

8 (2)

5 (2)

  Vaginitis

6 (2)

8 (2)

7 (2)

1 (0)

In addition, the following events were considered as related to the study drug with an incidence less than 1 percent, including accidental injury, infection, myalgia, cough increased, rhinitis, sinusitis, and upper respiratory infection.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of PREMPRO or PREMPHASE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Genitourinary System

Abnormal uterine bleeding, dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata, vaginitis, vaginal candidiasis, amenorrhea, changes in cervical secretion, ovarian cancer, endometrial hyperplasia, endometrial cancer.

Breasts

Tenderness, enlargement, pain, nipple discharge, galactorrhea, fibrocystic breast changes, breast cancer.

Cardiovascular

Deep and superficial venous thrombosis, pulmonary embolism, superficial thrombophlebitis, myocardial infarction, stroke, increase in blood pressure.

Gastrointestinal

Nausea, vomiting, abdominal pain, bloating, cholestatic jaundice, increased incidence of gallbladder disease, pancreatitis, changes in appetite, ischemic colitis.

Skin

Chloasma or melasma that may persist when drug is discontinued, erythema multiforme, erythema nodosum, loss of scalp hair, hirsutism, pruritus, urticaria, rash, acne.

Eyes

Retinal vascular thrombosis, intolerance of contact lenses.

Central Nervous System

Headache, migraine, dizziness, mental depression, exacerbation of chorea, mood disturbances, anxiety, irritability, exacerbation of epilepsy, dementia, growth potentiation of benign meningioma.

Miscellaneous

Increase or decrease in weight, arthralgia, glucose intolerance, edema, changes in libido, exacerbation of asthma, increased triglycerides, hypersensitivity.

Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.

Medication Guide

Health Professional Information

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Resources

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FDA Medwatch

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