HYDROQUINONE

N/A

Manufactured by Obagi Cosmeceuticals LLC

1,310 FDA adverse event reports analyzed

Last updated: 2026-04-15

About HYDROQUINONE

HYDROQUINONE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Obagi Cosmeceuticals LLC. The most commonly reported adverse reactions for HYDROQUINONE include SQUAMOUS CELL CARCINOMA OF SKIN, FATIGUE, DRUG INEFFECTIVE, PAIN, PRURITUS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for HYDROQUINONE.

Top Adverse Reactions

SQUAMOUS CELL CARCINOMA OF SKIN44 reports
FATIGUE43 reports
DRUG INEFFECTIVE42 reports
PAIN41 reports
PRURITUS35 reports
PRODUCT USE IN UNAPPROVED INDICATION34 reports
OFF LABEL USE32 reports
CONDITION AGGRAVATED31 reports
ANXIETY30 reports
ARTHRALGIA27 reports
DIARRHOEA27 reports
RASH27 reports
CHRONIC KIDNEY DISEASE25 reports
NAUSEA23 reports
SKIN ATROPHY22 reports
DIZZINESS20 reports
DYSPNOEA19 reports
HEADACHE19 reports
INSOMNIA19 reports
PAIN IN EXTREMITY19 reports
ALOPECIA18 reports
EMOTIONAL DISTRESS18 reports
ASTHENIA16 reports
BACK PAIN16 reports
VOMITING16 reports
CONSTIPATION15 reports
DRY SKIN15 reports
ERYTHEMA15 reports
ACNE14 reports
NEOPLASM SKIN14 reports
PYREXIA14 reports
MUSCLE SPASMS13 reports
SKIN DISCOLOURATION13 reports
ABDOMINAL PAIN12 reports
CHEST PAIN12 reports
SKIN EXFOLIATION12 reports
APPLICATION SITE PAIN11 reports
COUGH11 reports
DEEP VEIN THROMBOSIS11 reports
FALL11 reports
MYALGIA11 reports
OCHRONOSIS11 reports
RENAL FAILURE11 reports
WEIGHT DECREASED11 reports
BLOOD PRESSURE INCREASED10 reports
INJECTION SITE PAIN10 reports
MEMORY IMPAIRMENT10 reports
PULMONARY EMBOLISM10 reports
WEIGHT INCREASED10 reports
ABDOMINAL PAIN UPPER9 reports
DEPRESSION9 reports
HYPERTENSION9 reports
NASOPHARYNGITIS9 reports
PERIPHERAL SWELLING9 reports
PRODUCT DOSE OMISSION ISSUE9 reports
SKIN BURNING SENSATION9 reports
URTICARIA9 reports
ACUTE KIDNEY INJURY8 reports
ANAEMIA8 reports
ANHEDONIA8 reports
BURNING SENSATION8 reports
CONTUSION8 reports
ECZEMA8 reports
INCORRECT DRUG ADMINISTRATION DURATION8 reports
OROPHARYNGEAL PAIN8 reports
RHEUMATOID ARTHRITIS8 reports
SINUSITIS8 reports
SWELLING FACE8 reports
ABDOMINAL DISTENSION7 reports
COVID 197 reports
GAIT DISTURBANCE7 reports
INJURY7 reports
MALAISE7 reports
MIGRAINE7 reports
SWELLING7 reports
THERAPY INTERRUPTED7 reports
ARTHRITIS6 reports
BONE DENSITY DECREASED6 reports
CELLULITIS6 reports
CHEST DISCOMFORT6 reports
DECREASED APPETITE6 reports
DISCOMFORT6 reports
DRUG HYPERSENSITIVITY6 reports
DRY EYE6 reports
ECONOMIC PROBLEM6 reports
END STAGE RENAL DISEASE6 reports
EYE SWELLING6 reports
GASTROOESOPHAGEAL REFLUX DISEASE6 reports
HAIR TEXTURE ABNORMAL6 reports
HYPERSENSITIVITY6 reports
ILLNESS6 reports
INTENTIONAL PRODUCT USE ISSUE6 reports
MUSCULOSKELETAL CHEST PAIN6 reports
NEUROPATHY PERIPHERAL6 reports
PIGMENTATION DISORDER6 reports
PSORIASIS6 reports
RASH ERYTHEMATOUS6 reports
SKIN HYPERPIGMENTATION6 reports
SKIN IRRITATION6 reports
SOMNOLENCE6 reports

Report Outcomes

Out of 559 classified reports for HYDROQUINONE:

Serious 56.9%Non-Serious 43.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female441 (86.1%)
Male68 (13.3%)
Unknown3 (0.6%)

Reports by Age

Age 4523 reports
Age 4717 reports
Age 5417 reports
Age 4616 reports
Age 5514 reports
Age 6314 reports
Age 5813 reports
Age 5911 reports
Age 419 reports
Age 579 reports
Age 629 reports
Age 428 reports
Age 488 reports
Age 498 reports
Age 538 reports
Age 648 reports
Age 658 reports
Age 397 reports
Age 517 reports
Age 527 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with HYDROQUINONE?

This profile reflects 1,310 FDA FAERS reports that mention HYDROQUINONE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for HYDROQUINONE?

Frequently reported terms in FAERS include SQUAMOUS CELL CARCINOMA OF SKIN, FATIGUE, DRUG INEFFECTIVE, PAIN, PRURITUS, PRODUCT USE IN UNAPPROVED INDICATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures HYDROQUINONE?

Labeling and FAERS entries often list Obagi Cosmeceuticals LLC in connection with HYDROQUINONE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.