DOXYCLYCLINE HYCLATE

N/A

Manufactured by Lupin Pharmaceuticals, Inc.

70,851 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DOXYCLYCLINE HYCLATE

DOXYCLYCLINE HYCLATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Lupin Pharmaceuticals, Inc.. The most commonly reported adverse reactions for DOXYCLYCLINE HYCLATE include DRUG HYPERSENSITIVITY, FATIGUE, NAUSEA, PAIN, RASH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOXYCLYCLINE HYCLATE.

Top Adverse Reactions

DRUG HYPERSENSITIVITY2,217 reports
FATIGUE1,603 reports
NAUSEA1,525 reports
PAIN1,358 reports
RASH1,313 reports
HEADACHE1,270 reports
OFF LABEL USE1,247 reports
DRUG INEFFECTIVE1,246 reports
DIARRHOEA1,211 reports
VOMITING1,196 reports
DYSPNOEA1,165 reports
PNEUMONIA1,068 reports
PRURITUS1,016 reports
CONDITION AGGRAVATED994 reports
DIZZINESS990 reports
ARTHRALGIA926 reports
ANXIETY885 reports
INFECTION880 reports
HYPERTENSION873 reports
SINUSITIS842 reports
MALAISE836 reports
HYPERSENSITIVITY810 reports
ABDOMINAL DISCOMFORT790 reports
PYREXIA779 reports
HYPOAESTHESIA764 reports
RHEUMATOID ARTHRITIS762 reports
PERIPHERAL SWELLING759 reports
NASOPHARYNGITIS758 reports
DECREASED APPETITE756 reports
URTICARIA751 reports
ASTHMA744 reports
ALOPECIA738 reports
JOINT SWELLING728 reports
INSOMNIA716 reports
WEIGHT INCREASED709 reports
WEIGHT DECREASED700 reports
HEPATIC ENZYME INCREASED688 reports
PAIN IN EXTREMITY683 reports
ASTHENIA678 reports
INFUSION RELATED REACTION672 reports
WHEEZING663 reports
DEPRESSION660 reports
CHEST PAIN646 reports
GENERAL PHYSICAL HEALTH DETERIORATION645 reports
CONFUSIONAL STATE640 reports
IMPAIRED HEALING628 reports
MUSCULOSKELETAL STIFFNESS621 reports
FIBROMYALGIA609 reports
SWELLING608 reports
DRUG INTOLERANCE607 reports
MOBILITY DECREASED601 reports
INJURY591 reports
CONTUSION587 reports
SYNOVITIS585 reports
ARTHROPATHY579 reports
PRODUCT USE IN UNAPPROVED INDICATION578 reports
HELICOBACTER INFECTION576 reports
GLOSSODYNIA573 reports
HAND DEFORMITY572 reports
TYPE 2 DIABETES MELLITUS571 reports
BLISTER567 reports
RHEUMATOID FACTOR POSITIVE563 reports
ABDOMINAL PAIN UPPER561 reports
FOLLICULITIS559 reports
CHRONIC KIDNEY DISEASE554 reports
WOUND554 reports
SYSTEMIC LUPUS ERYTHEMATOSUS549 reports
GAIT DISTURBANCE544 reports
STOMATITIS536 reports
DUODENAL ULCER PERFORATION533 reports
IRRITABLE BOWEL SYNDROME532 reports
DISCOMFORT526 reports
PSORIATIC ARTHROPATHY525 reports
ROAD TRAFFIC ACCIDENT521 reports
OSTEOARTHRITIS520 reports
BLOOD CHOLESTEROL INCREASED514 reports
GASTROINTESTINAL DISORDER510 reports
ARTHRITIS509 reports
DEATH506 reports
PERICARDITIS501 reports
MEMORY IMPAIRMENT499 reports
PRODUCT DOSE OMISSION ISSUE488 reports
OEDEMA PERIPHERAL486 reports
PEMPHIGUS486 reports
OEDEMA485 reports
PRODUCT USE ISSUE481 reports
MUSCLE INJURY479 reports
COUGH476 reports
SLEEP DISORDER474 reports
JOINT RANGE OF MOTION DECREASED473 reports
RHEUMATIC FEVER467 reports
MATERNAL EXPOSURE DURING PREGNANCY466 reports
AUTOIMMUNE DISORDER459 reports
DYSPEPSIA457 reports
LIVER INJURY455 reports
SCIATICA455 reports
DEEP VEIN THROMBOSIS POSTOPERATIVE453 reports
MUSCLE SPASMS450 reports
LOWER LIMB FRACTURE448 reports
C REACTIVE PROTEIN ABNORMAL444 reports

Report Outcomes

Out of 15,907 classified reports for DOXYCLYCLINE HYCLATE:

Serious 59.0%Non-Serious 41.0%

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

Female10,124 (69.0%)
Male4,522 (30.8%)
Unknown24 (0.2%)

Reports by Age

Age 44599 reports
Age 43376 reports
Age 59243 reports
Age 63243 reports
Age 50223 reports
Age 61223 reports
Age 64216 reports
Age 68213 reports
Age 71211 reports
Age 69208 reports
Age 72208 reports
Age 70203 reports
Age 65201 reports
Age 62200 reports
Age 67192 reports
Age 66187 reports
Age 56185 reports
Age 73184 reports
Age 76184 reports
Age 74178 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 DOXYCLYCLINE HYCLATE?

This profile reflects 70,851 FDA FAERS reports that mention DOXYCLYCLINE HYCLATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DOXYCLYCLINE HYCLATE?

Frequently reported terms in FAERS include DRUG HYPERSENSITIVITY, FATIGUE, NAUSEA, PAIN, RASH, HEADACHE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DOXYCLYCLINE HYCLATE?

Labeling and FAERS entries often list Lupin Pharmaceuticals, Inc. in connection with DOXYCLYCLINE HYCLATE. 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.